Heroin detoxification with buprenorphine on an inpatient ...
Heroin detoxification with buprenorphine on an inpatient psychiatric unit . Journal of Substance Abuse Treatment , Volume 23 , Issue 3 , Pages 163 - 169 B . DiPaula , R . Schwartz , I . Montoya , D . Barrett , C . Tang
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| | |The purpose of this open-label, uncontrolled study was to evaluate the feasibility of administering off-label buprenorphine in combination with ancillary|
| | |medications for inpatient short-term detoxification of heroin-dependent patients at a psychiatric facility. A sample of 20 heroin-dependent patients |
| | |admitted to an urban psychiatric hospital was administered buprenorphine 6, 4, and 2 mg/day during the first, second, and third day of detoxification, |
| | |respectively, and then observed during the fourth and fifth day. Eighty-five percent of the subjects abused other substances, 75% reported cocaine |
| | |abuse/dependence, 75% had comorbid mood disorders. All subjects completed the medication phase of the study. No clinically significant adverse events |
| | |were reported. There was a significant decrease in the Clinical Investigation Narcotic Assessment (CINA) total score between baseline and days 2 through |
| | |5. The results suggest that buprenorphine is well tolerated and may be beneficial for medically supervised short-term withdrawal from heroin for |
| | |hospitalized psychiatric patients. |
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Opioid dependence - Management
How should I prescribe buprenorphine for someone on street heroin who wants to undergo detoxification?
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▪ Buprenorphine detoxification may be carried out at different rates according to the person's preference, drug use, and history, although expert opinion is that detoxification should happen very fast over a 10-day period (see Table 1) or more slowly (2 mg to 4 mg per week). The dose of buprenorphine determines the speed of reduction:
o With higher doses, reduction can be fast.
o With middle-range doses, the reduction is slower.
o With lower doses, reduction may be faster, particularly when aided by lofexidine.
Table 1. Proposed schedule for very fast detoxification from heroin using buprenorphine.
|Day of detoxification |
▪ Expert opinion differs on whether or not diazepam should be given. It should only be given as part of an agreed detoxification schedule in people who are not known to abuse it. Benzodiazepines do not reduce the severity of withdrawal symptoms, but help the person feel better. Diazepam may be appropriate in someone with acute withdrawal who is requesting detoxification with buprenorphine rather than maintenance treatment. When diazepam is prescribed as part of the management of illicit drug use, it should be issued on the FP10MDA-SS (blue) prescription form for daily pick-up from the pharmacy:
o The person must be in withdrawal before buprenorphine can be commenced, and will often be agitated.
o Diazepam (10 mg to 20 mg) can be taken the night before detoxification with buprenorphine is started.
o A second dose (10 mg to 20 mg) may be taken the following night, but it is very rare that any further doses will
o be needed.
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How should I prescribe methadone for detoxification from street heroin?
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▪ Methadone is not a good drug to use for detoxification from street heroin.
▪ Some clinicians and their patients may choose to use methadone. This requires titration of the dose until symptoms and signs of withdrawal have disappeared (see Starting maintenance treatment with methadone) and then a reduction at a speed dependent on the individual person but usually reducing the dose by 5 mg weekly. It is also possible to reduce to a dose of methadone 30 mg/day or less and then switching to buprenorphine for the final reduction. See Starting maintenance treatment with buprenorphine.
Basis for recommendation
▪ Methadone is the standard treatment for people who are taking maintenance treatment but is less preferred for detoxification [RCGP, 2005b; Ford, Personal Communication, 2006].
▪ Methadone is more commonly used for maintenance rather that detoxification. Our reviewers stressed that buprenorphine is the first choice drug for detoxification. Withdrawing from methadone is a reduction leading to abstinence rather than a detoxification. The suggested regime is based on feedback from expert reviewers.
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Buprenorphine and carbamazepine as a treatment for detoxification of opiate addicts with multiple drug misuse: a pilot study
U. Schneider 2 , W. Paetzold 2 , V. Eronat 2 , T. J. Huber 2 , J. Seifert 2 , B. Wiese 1 H. M. Emrich 2
2 Department of Clinical Psychiatry and Psychotherapy, School of Medicine, Hannover, Germany 1 Department of Biometry, School of Medicine, Hannover, Germany
Correspondence to: PD Dr U. Schneider, Department of Clinical Psychiatry and Psychotherapy, School of Medicine, 30625 Hannover, Germany Tel: 0511 5326559; Fax: 0511 5322415; e-mail: schneider.udo@mh-hannover.de
Copyright 2000 Society for the Study of Addiction to Alcohol and Other Drugs
Abstract
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The growing tendency of opioid addicts to misuse multiple other drugs leads to the investigation of new pharmacostrategies to prevent patients from suffering life-threatening complications and minimize the withdrawal symptoms. The short-term efficacy of a 10-day low-dose buprenorphine/19-day carbamazepine regime (n = 15) to a 14-day oxazepam/19-day carbamazepine regime (n = 12) in an open-labelled 21-day inpatient detoxification treatment was compared. Twenty-seven men and women dependent on opioids and misusing other drugs admitted to a detoxification unit were included in this protocol. Eighteen of 27 patients (67%) completed the study. Four non-completers (27%) received buprenorphine/carbamazepine (four of 15) and five non-completers (42%) were treated with oxazepam/carbamzepine (five of 12), but the difference in the dropout rate between the two treatment strategies was not significant.The buprenorphine/carbamazepine regime provided significantly more effective relief of withdrawal symptoms during the first week of treatment. No severe side effects occurred during treatment in both groups. The present study supports the hypothesis that buprenorphine/carbamazepine is more effective than oxazepam/carbamazepine in rapid opioid detoxification in patients with additional multiple drug misuse and both regimens were safe with no unexpected side effects.
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2
AU - Kutz I
AU - Reznik V
AD - Psychiatric Services, Meir General Hospital, Kfar-Saba, Israel. ikutz@.il
TI - Rapid heroin detoxification using a single high dose of buprenorphine
AB - To test the effect of 32 mg of buprenorphine on the withdrawal process from heroin, 10 street-heroin using subjects were given 32 mg of sublingual buprenorphine, following heroin abstinence of 24 hours. Withdrawal symptoms were monitored during the first few hours, and followed for six days after buprenorphine administration, after which naltrexone (50 mg) was introduced to prevent future heroin use. Nine subjects completed detoxification with negligible withdrawal symptoms and a smooth transition to naltrexone. One subject was excluded from the study due to methadone ingestion prior to experiment. These results strongly suggest that painless detoxification from heroin can be obtained by a single high dose of buprenorphine
UR - PM:11476266
SO - J Psychoactive Drugs 2001 Apr ;33(2):191-193
11
AU - Gowing L
AU - Ali R
AU - White J
AD - Evidence-Based Practice Unit, Drug and Alcohol Services Council, 161 Greenhill Road, Parkside, SA, Australia, 5067. gowing.linda@saugov..au
TI - Buprenorphine for the management of opioid withdrawal
AB - BACKGROUND: Managed withdrawal, or detoxification, is not in itself a treatment for opioid dependence, but it is a required first step for many forms of longer-term treatment. It may also represent the end point of an extensive period of treatment such as methadone maintenance. As such, managed withdrawal is an essential component of an effective treatment system. This review is one of a series that aims to assess the evidence as to the effectiveness of the variety of approaches to managing opioid withdrawal. OBJECTIVES: To assess the effectiveness of interventions involving the short-term use of buprenorphine to manage the acute phase of opioid withdrawal. SEARCH STRATEGY: Multiple electronic databases, including Medline, Embase, Psychlit, Australian Medical Index and Current Contents, were searched using a strategy designed to retrieve references broadly addressing the management of opioid withdrawal. Reference lists of retrieved studies, reviews and conference abstracts were handsearched. SELECTION CRITERIA: We included randomised or quasi-randomised controlled clinical trials or prospective controlled cohort studies comparing buprenorphine (treatment 10 days or less) with another form of treatment. Studies were required to provide detailed information on the type and dose of drugs used and the characteristics of patients treated. Studies were also required to provide information on the nature of withdrawal signs and symptoms experienced, the occurrence of adverse effects OR rates of completion of the withdrawal episode. DATA COLLECTION AND ANALYSIS: Potentially relevant studies were assessed for inclusion by one reviewer (LG). Inclusion decisions were confirmed by consultation between reviewers. Included studies were assessed by all reviewers. One reviewer (LG) undertook data extraction with the process confirmed by consultation between all three reviewers. MAIN RESULTS: Five studies met the criteria for inclusion in the review. No data tables are included in this review and no meta-analysis has been undertaken because of differences in treatment regimes and the assessment of outcomes in these studies. Four studies compared buprenorphine with clonidine. All found withdrawal to be less severe in the buprenorphine treatment group. In three of these studies all participants were withdrawing from heroin. Participants in one study were withdrawing from methadone, with doses reduced to 10mg/day prior to treatment with buprenorphine. Three of the studies commented on residual symptoms experienced by participants treated with buprenorphine to manage heroin withdrawal. Aches, restlessness, yawning, mydriasis, tremor, insomnia, nausea and mild anxiety were reported as being experienced by some participants. Rates of completion of withdrawal were able to be calculated for all studies included in the review but the definition of completion varied between studies. Rates ranged from 65% to 100%. None of the studies included in the review reported adverse effects. However, approximately approximately Lintzeris 1999a approximately approximately (a single-group study which therefore did not meet the inclusion criteria) reported 50% of participants withdrawing from heroin experienced headaches, 28% sedation, 21% nausea, 21% constipation, 21% anxiety, 17% dizziness and 17% itchiness during withdrawal. These adverse effects were most common in the first 2-3 days of treatment and then subsided. In four of the five studies treatment was undertaken on an inpatient basis. Only approximately approximately O'Connor 1997 approximately approximately provided outpatient treatment. However, two studies that did not meet the inclusion criteria ( approximately approximately Diamant 1998 approximately approximately and approximately approximately Lintzeris 1999a approximately approximately ) also provided outpatient treatment. The findings of these studies support the feasibility of heroin withdrawal being managed with buprenorphine on an outpatient basis
UR - PM:10908521
SO - Cochrane Database Syst Rev 2000 ;(3):CD002025
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12
AU - Blennow G
AU - Fergusson A
AU - Medvedeo A
AD - Universitetssjukhuset MAS, Malmo. blennow@swipnet.se
TI - [Buprenorphine as a new alternative for detoxification of heroin addicts. It causes only mild withdrawal problems, abating quickly]
AB - Buprenorphine might be an alternative drug to be used in opiate detoxification. Its main advantage is that it carries a low risk for respiratory depression, it gives less euphoria and limited withdrawal effects. In a pilot detoxification project ten heroin addicts were given buprenorphine; seven completed the course. Before detoxification seven patients showed five or more signs on the Himmelsbach scale [6]. After the second day four patients showed no signs, four patients displayed one sign, two patients two signs. Buprenorphine may be a valuable alternative to clonidine, dextropropoxiphene and methadone in the detoxification of opiate addicts
UR - PM:10815411
SO - Lakartidningen 2000 Apr 12 ;97(15):1830-1833
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14
AU - Umbricht A
AU - Montoya ID
AU - Hoover DR
AU - Demuth KL
AU - Chiang CT
AU - Preston KL
AD - NIDA Intramural Research Program, Addiction Research Center, Baltimore, MD, USA. aumbri@intra.nida.
TI - Naltrexone shortened opioid detoxification with buprenorphine
AB - This double-blind, randomized, placebo-controlled clinical trial evaluated the impact on withdrawal symptoms of (i) combining naltrexone with a 4-day buprenorphine taper for short opioid detoxification (NB Group), compared to (ii) using a 4-day buprenorphine taper alone, followed by naltrexone on day 8 (PB Group). Sublingual buprenorphine was administered on days 1-4 (26 mg total). For the NB Group (n = 32) escalating doses of oral naltrexone were given on days 2-8 (placebo day 1). For the PB Group (n = 28) placebo was given on days 1-7 and naltrexone on day 8. Main outcome measures were Observed Opioid Withdrawal scores (OOW, 0-30) and use of medications to treat opioid withdrawal. Of 32 patients in the NB group, 59% experienced clinically relevant withdrawal (defined as OOW > or = 5) on day 2, but, after day 5, none experienced withdrawal. In the PB group, the number of patients experiencing withdrawal increased over time. The first naltrexone dose induced comparable withdrawal in both groups: peak OOW scores were (mean +/- SD) 5.2 +/- 3.3 on day 2 for the NB group, and 4.0 +/- 3.9 on day 8 for the PB group (NS), though, on day 2, 7 patients dropped out in the NB group and none in the PB group, while only one patient dropped out in the PB group on day 8. Throughout the 8-day study, patients in both groups received similar amount of adjunct medication: 0.64 +/- 0.07 mg (NB group) of clonidine vs 0.73 +/- 0.15 mg (PB group; NS). Only 25% of patients required use of sedatives (up to 20 mg diazepam). Starting naltrexone on day 2 appeared to abolish withdrawal symptoms after day 5 and, thus, to shorten the duration of withdrawal symptoms. Peak withdrawal symptoms after naltrexone were of moderate intensity, suggesting that naltrexone combined with buprenorphine is an acceptable and safe treatment for shortened opioid detoxification and induction of naltrexone maintenance
UR - PM:10529020
SO - Drug Alcohol Depend 1999 Oct 1 ;56(3):181-190
15
AU - Liu ZM
AU - Cai ZJ
AU - Wang XP
AU - Ge Y
AU - Li CM
AD - National Institute on Drug Dependence, Beijing Medical University, China
TI - Rapid detoxification of heroin dependence by buprenorphine
AB - AIM: To evaluate the clinical efficacy of buprenorphine (Bup) in treatment of acute heroin withdrawal. METHODS: Bup was given sublingually daily to 60 cases of heroin addicts in 3 groups: low, medium, and high doses. Withdrawal signs and symptoms of heroin were rated by Clinical Institute Narcotic Assessment. Craving for heroin during detoxification was assessed by Visual Analogue Scale. The side effects of Bup was assessed by Treatment Emergent Symptom Scale. RESULTS: The mean daily consumption of Bup in low, medium, and high group was 2.0, 2.9, and 3.6 mg, respectively. Bup not only suppressed objective signs and withdrawal symptoms for heroin withdrawal, but also reduced the duration for heroin detoxification over 7-8 d. CONCLUSION: Bup is an effective and rapid detoxification agent with fewer side effects for treatment of acute heroin withdrawal
UR - PM:10072959
SO - Zhongguo Yao Li Xue Bao 1997 Mar ;18(2):112-114
AU - Vignau J
AD - Centre Hospitalier et Universitaire, Lille, France. jvignau@nordnet.fr
TI - Preliminary assessment of a 10-day rapid detoxification programme using high dosage buprenorphine
AB - The original French therapeutic strategy for the treatment of opioid addiction was a rapid detoxification occasionally accompanied by treatment for withdrawal symptoms. In 1995, substitution therapy using opioids was introduced with the aim of maintenance, utilising methadone and the partial agonist buprenorphine, introduced in 1996. As well as being a maintenance agent, buprenorphine has been prescribed for rapid detoxification due to its reduced tendency to cause any withdrawal effects and its ability to block the effects of other opioids. This trial was initiated to measure the efficacy of buprenorphine in rapid detoxification and to assess whether additional medication would be required. Participants in this open study had requested rapid detoxification and were referred to the addiction clinic as inpatients. Patients were assessed by the clinician and during counselling sessions, and an initial dose was agreed upon. This dose was then gradually decreased over ten days in a flexible dosing schedule, with concurrent toxicological urinalysis to ensure no illicit drug use. During the trial, 25% of patients transferred to a maintenance programme and 58% remained in the study. The large transfer of patients to maintenance programmes may indicate that many people requesting rapid detoxification are actually asking for a more generalised form of assistance. No opioid-positive urines were noted after the fourth day in any patients, and the study indicates that buprenorphine should prove to be a useful detoxification agent, particularly in less hardened addicts. Step-down buprenorphine detoxification minimises withdrawal symptoms and, therefore, reduces the need for concurrent medication
UR - PM:9767204
SO - Eur Addict Res 1998 ;4 Suppl 1():29-31
Tramadol versus Buprenorphine for the Management of Acute Heroin Withdrawal: A Retrospective Matched Cohort Controlled Study
Authors: Melinda Threlkeld - Dr. Threlkeld is now in the Department of Emergency Medicine, Carolina State Medical Center, Charlotte, NC.a; Theodore V. Parran Jr. abc; Christopher A. Adelman bd; Scott F. Grey de; Jaehak Yu cf
|Affiliations: |a Department of Medicine, Case Western Reserve University School of Medicine, Cleveland, Ohio |
| |b St. Vincent Charity Hospital and Rosary Hall, Cleveland, Ohio |
| |c Cleveland VA Medical Center, Cleveland, Ohio |
| |d Department of Family Medicine, Case Western Reserve University School of Medicine, Cleveland, Ohio |
| |e Division of Epidemiology and Bio-statistics, Case Western Reserve University School of Medicine, Cleveland, Ohio |
| |f Department of Psychiatry, University Hospitals of Cleveland, Cleveland, Ohio |
DOI: 10.1080/10550490500528712
Publication Frequency: 6 issues per year
Published in: [pic]American Journal on Addictions, Volume 15, Issue 2 May 2006 , pages 186 - 191
Subject: Addiction & Treatment;
Formats available: HTML (English) : PDF (English)
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|Abstract |
|Many medications have been used over the past thirty years for the treatment of opioid withdrawal, including propoxyphene, methadone, |
|clonidine, parenteral buprenorphine, and, more recently, sublingual buprenorphine. Each has been found to have clinical strengths and |
|limitations. Tramadol is a centrally acting synthetic analgesic with opiate activity primarily due to the binding of a metabolite to |
|the μ receptor. Despite this μ receptor activity, tramadol appears to have low abuse potential and is a non-scheduled analgesic. The |
|pharmacologic profile of tramadol makes it a candidate for opiate withdrawal treatment. A chart review was undertaken to |
|retrospectively compare treatment outcomes of heroin-dependent patients when detoxified with parenteral buprenorphine (1996-1997) |
|versus tramadol (1999-2000). Inclusion criteria for this study were heroin as drug of choice, current opioid physical dependence (ie, |
|withdrawal symptoms), no current abuse of oral opioid analgesics, and no alcohol or benzodiazepine withdrawal symptoms. Patient cases |
|that met inclusion criteria were group-matched between buprenorphine and tramadol on the basis of age, sex, and amount of heroin used |
|(bags/day). Charts were audited for patient demographics, daily heroin use at admission, withdrawal symptoms, and discharge status. In|
|total, 129 patient charts were reviewed, and 115 met all inclusion criteria and were group-matched (45 patients in the buprenorphine |
|group, seventy in the tramadol group). There were no differences in demographics between the two groups of patients. Fifty-six percent|
|of the buprenorphine group and 71% of the tramadol group completed detoxification; tramadol-treated patients had significantly higher |
|average withdrawal symptoms when compared to the buprenorphine group and a greater reduction in withdrawal symptoms over time. |
|Finally, the number of side effects was small and did not differ between the groups. The results of this study are consistent with |
|previous pilot reports that indicated few clinical differences between parenteral buprenorphine and oral tramadol protocols when used |
|in the management of acute heroin withdrawal. As a consequence, tramadol shows some promise as an opioid withdrawal management |
|medication. |
Received: 22.1.2005 Accepted: 1.6.2005
Journal of Research in Medical Sciences May & June 2006; Vol 11, No 3 185
Original Article
Tramadol versus methadone for the management of
acute opioid withdrawal: an add-on study
M. Salehi*, M. Amanatkar**, M. Barekatain*
ABSTRACT
BACKGROUND: Opioid agonists such as methadone have been used widely in controlling opioid withdrawal symptoms.
Tramadol, a partial opioid agonist, also has been prescribed to manage acute and chronic pain. We sought to compare
the efficacy of tramadol and methadone in reducing the severity of opioid withdrawal symptoms.
METHODS: In a double blind clinical trial 70 opioid dependent patients who used daily opium equal to 15 mg methadone
randomly were assigned in two groups. In one group, methadone was started at 15 mg/day while in the other
group 450 mg/day tramadol was prescribed. Both drugs were tapered in a week and placebo was prescribed in the 2nd
week. The severity of withdrawal symptoms were assessed five times by short opioid withdrawal scale (SOWS). Data
were analyzed by Repeated Measures Analysis of Variance, Mann-Whitney U, and Wilcoxon tests.
RESULTS: There were statistically significant differences between two groups in the severity of anxiety (P = 0.015), irritability
(P = 0.044), palpitation (P = 0.018), agitation (P = 0.037), and dysphoria (P = 0.044) that all were more common
in methadone group. Comparison of side effects revealed statistically significant differences in sweating (P = 0.003) and
drowsiness (P = 0.019) between two groups that were more frequent in methadone group.
DISCUSSION: Tramadol was more efficacious in controlling opioid withdrawal symptoms with lower side effects.
KEYWORDS: Methadone, tramadol, opioid withdrawal
Bringing Buprenorphine-Naloxone Detoxification to Community Treatment Providers: The NIDA Clinical Trials Network Field Experience
Leslie Amass, Ph.D., Walter Ling, M.D., Thomas E. Freese, Ph.D., Chris Reiber, Ph.D., M.P.H., Jeffrey J. Annon, M.A., Allan J. Cohen, M.A., M.F.T., Dennis McCarty, Ph.D., Malcolm S. Reid, Ph.D., Lawrence S. Brown, Jr., M.D., Cynthia Clark, M.S.N., C.R.N.P., Douglas M. Ziedonis, M.D., Jonathan Krejci, Ph.D., Susan Stine, M.D., Ph.D., Theresa Winhusen, Ph.D., Greg Brigham, Ph.D., Dean Babcock, M.S.W., L.C.S.W., Joan A. Muir, Ph.D., Betty J. Buchan, Ph.D., and Terry Horton, M.D.
In October 2002, the U.S. Food and Drug Administration approved buprenorphine-naloxone (Suboxone®) sublingual tablets as an opioid dependence treatment available for use outside traditionally licensed opioid treatment programs. The NIDA Center for Clinical Trials Network (CTN) sponsored two clinical trials assessing buprenorphine-naloxone for short-term opioid detoxification. These trials provided an unprecedented field test of its use in twelve diverse community-based treatment programs. Opioid-dependent men and women were randomized to a thirteen-day buprenorphine-naloxone taper regimen for short-term opioid detoxification. The 234 buprenorphine-naloxone patients averaged 37 years old and used mostly intravenous heroin. Direct and rapid induction onto buprenorphine-naloxone was safe and well tolerated. Most patients (83%) received 8 mg buprenorphine-2 mg naloxone on the first day and 90% successfully completed induction and reached a target dose of 16mg buprenorphine-4 mg naloxone in three days. Medication compliance and treatment engagement was high. An average of 81% of available doses was ingested, and 68% of patients completed the detoxification. Most (80.3%) patients received some ancillary medications with an average of 2.3 withdrawal symptoms treated. The safety profile of buprenorphine-naloxone was excellent. Of eighteen serious adverse events reported, only one was possibly related to buprenorphine-naloxone. All providers successfully integrated buprenorphine-naloxone into their existing treatment milieus. Overall, data from the CTN field experience suggest that buprenorphine-naloxone is practical and safe for use in diverse community treatment settings, including those with minimal experience providing opioid-based pharmacotherapy and/or medical detoxification for opioid dependence.
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Buprenorphine Rescue from Naltrexone-Induced Opioid Withdrawal During Relatively Rapid Detoxification from High-Dose Methadone: A Novel Approach
April 2008
by Vanessa Urban, MD; and Rolly Sullivan, MD
Dr. Urban is Clinical Instructor and Dr. Sullivan is Professor, Department of Behavioral Health and Psychiatry, West Virginia University of Medicine, Morgantown, Virginia.
Abstract
This small series of case reports illustrates a significantly faster and well tolerated method for a relatively rapid detoxification from high-dose methadone as compared to traditional methadone detoxification regimens. After inducing a withdrawal state using oral naltrexone, the patients were quickly “rescued” with buprenorphine (a combination of buprenorphine/naloxone). By administering a medication that attenuates withdrawal symptoms, patients immediately began to feel better and were better able to invest themselves in the overall treatment. The patients were then able to taper off opioids in a matter of days with minimal discomfort. The average length of stay was seven days, and no patients left before completing the program.
Key Words
methadone, buprenorphine, suboxone, naltrexone, revia, rapid detoxification, high dose
Introduction
Opioid dependence is a growing concern in the United States. The 2003 National Survey on Drug Use and Health showed 3.2 percent of Americans misused prescription drugs. Abstinence remains the goal of treatment, but often patients relapse when going through the physical withdrawal symptoms that present with opioid cessation. In today’s managed healthcare climate, there is an ever-increasing pressure to treat patients quickly, and this is especially true for inpatient treatments. Often patients request a faster method of detoxification than the standard methadone taper as set forth by methadone clinics.[1 ]We propose a novel approach to address the issue of providing a relatively rapid method of inpatient detoxification from high dose methadone (>70mg in our review) by using a combination of oral naltrexone followed by sublingual buprenorphine/naltrexone.
Methods
The author performed a 12-month retrospective chart review of all inpatients of the addiction unit at a university hospital in Morgantown, West Virginia. Five patients (3 men, 2 women) each requesting detoxification from methadone were admitted on doses of methadone ranging from 70mg to 130mg per day. All endorsed receiving their regular methadone dose the day prior to admission. Patients chosen for this retrospective chart review received naltrexone followed by buprenorphine/naltrexone during their detoxification. Information was obtained from medical records.
Background. Buprenorphine acts as a Mu partial agonist and a moderate kappa antagonist.[1–3] The properties that make it ideal as a detoxification medication are its high affinity for and slow dissociation from the Mu opioid receptors, its minimal withdrawal when stopped abruptly, its minimal euphoric effects, its safety in overdose, and its ability to block receptors from illicit opioid ingestion.[1,4,5] There is preliminary data that it may also reduce opioid cravings.[1,4] Because buprenorphine has a higher affinity for the opioid receptor than methadone, but only 40 percent of methadone’s efficacy, a direct methadone to buprenorphine/naloxone regimen has proven clinically difficult unless the daily methadone dose is 30mg or less.[1,6]
Participants. After a chart review spanning a 12-month period, five patients met the inclusion criteria of a maintenance methadone dosage of 70mg or more per day. Patients included in this case review were adults 18 years of age or older who had a full history and physical as well as standard laboratory work done at the time of their admission. The daily methadone doses of the five cases in this review were 70mg, 75mg, 100mg, 100mg, and 130mg.
Procedure. On admission, all patients were given the choice of clonidine 0.2mg tablets on an as needed basis or weekly TTS-2 (0.2mg/24 hours) clonidine patches. The patients were then educated regarding the induction of opioid withdrawal with naltrexone as well as the pharmacologic properties of sublingual buprenorphine/naloxone that render it ineffective if not taken sublingually. It was explained that after the initial oral dose of naltrexone 25mg, opioid withdrawal symptoms typically took 30 to 45 minutes to be strong enough to warrant a buprenorphine/naloxone dose. After this orientation to the procedure, the patients were then given their initial naltrexone doses, encouraged to self-report any symptoms of opioids withdrawal, and were monitored by the staff for signs and symptoms of withdrawal.
Assessments. Full opioid withdrawal was assessed by staff’s observation of vital signs, onset of nausea, vomiting, diarrhea, rhinorrhea, and yawning in conjunction with patient’s self-reporting of muscle aches, abdominal cramping, irritability, and anxiety. An initial dose of 4 to 6mg of sublingual buprenorphine/naloxone was then given. The dosage for maintenance of symptom relief was then obtained during the first 24-hour period of buprenorphine/naloxone treatment. This dose was then tapered off over several days based on the individual’s clinical course.
Results
The induction/rescue technique had promising results. Typical opioid withdrawal symptoms occurred within 45 minutes of the naltrexone dose, and using it to induce withdrawal circumvented a premature methadone to buprenorphine/naloxone transfer. All patients placed on the intermediate step of naltrexone induction followed by buprenorphine/naloxone rescue completed the detoxification process and expressed gratitude at the efficiency of the process.
Discussion
Traditionally, detoxification from high-dose methadone is a long process. The lowest daily dose of methadone we treated was 70mg daily, which would have taken 15 weeks using a traditional outpatient taper. Our average detoxification was seven days with naltrexone-induced withdrawal followed by a sublingual buprenorphine/naloxone rescue.
We opted to use the “rescue” approach rather than a direct methadone to buprenorphine approach for several reasons. The first was that withdrawal could be quickly and predictably initiated, thus starting buprenorphine treatment sooner. Another was the concern that if a direct methadone to buprenorphine transfer is initiated, significant withdrawal would result due to buprenorphine being a partial agonist but at the same time having the highest affinity for the Mu receptors. Therefore, the withdrawal would not be able to be reversed by the addition of other opioids, which could potentially cause a higher treatment dropout rate. The final reason was that it was felt in a dependent population, a medicine that could quickly reverse withdrawal symptoms would increase patient confidence in the medication and thus increase overall adherence with treatment. Although patients had to enter naltrexone-induced withdrawal before receiving buprenorphine/naloxone, they then had a sufficient “rescue” experience, which allowed them to complete the program. The total number of patients reviewed was small, but there were no dropouts with this method. At the time of the review, the issue of natural versus induced withdrawal was not addressed in the literature. It would be helpful if double-blind, placebo-controlled studies were done to compare outcomes between the methods of predicating withdrawal versus waiting for the natural course of withdrawal to ensue before initiating buprenorphine treatment.
Conclusion
Although this is a small series of cases, it raises some interesting possibilities. Methadone maintenance dosages usually range from 80mg to 120mg, and current literature endorses a slow 3 to 5mg per week taper of this drug.6 Patients’ attempts to wean themselves faster than this may foster relapse as signs and symptoms of withdrawal emerge, thus discouraging them from future attempts. Buprenorphine offers relief from withdrawal and acts as a deterrent to future illicit opioid usage secondary to its high opioid receptor affinity. It may prove beneficial to study the methods outlined in this paper of a naltrexone-induced withdrawal followed by a buprenorphine/naloxone rescue in controlled clinical trials.
References
1. Graham W, Schultz TK, Mayo-Smith MF, et al (eds). Principles of Addiction Medicine, Third Edition. Maryland, Md: American Society of Addiction Medicine, Inc., 2003.
2. Rothman RB, Ni Q, Xu H. Buprenorphine: A review of the binding literature. In: Cowan A, Lewi JW (eds). Buprenorphine: Combating Drug Abuse with a Unique Opioid. New York, NY: Wiley-Liss, 1995:19–30.
3. Johnson RE, Strain EC, Amass L. Buprenorphine: How to use it right. Drug Alcohol Depend 2003;70:S59–S77.
4. Fudala, PJ, et al. Office-based treatment of opiate addiction with a sublingual-tablet formulation of buprenorphine and naloxone. N Engl J Med 2003;349(10):949–58.
5. Johnson, RE. Buprenorphine and naloxone for heroin dependence. Curr Psychiatry Rep 2000;2(6):519–26.
6. McNicholas L. Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction: A Treatment Improvement Protocol TIP 40. Department of Health and Human Services, 2004. Available at: . Access date: April 7, 2008.
Titre du document / Document title
Low-dose buprenorphine detoxification in long term methadone addicts
Auteur(s) / Author(s)
JANIRI L. ; MANNELLI P. ; SERRETTI A. ; TEMPESTA E. ;
Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)
Catholic univ., dep. psychiatry, drug addiction unit, Rome, ITALIE
Résumé / Abstract
Discontinuation from long-term methadone is considered a problematic issue. Various pharmacological protocols for detoxification have been proven. Buprenorphine has recently been proposed as a promising drug in treating opioid withdrawal syndrome. The aim of this study was to describe the time course of withdrawal symptomatology of long-term methadone addicts treated with low doses of buprenorphine. Long-term methadone dependent inpatients were included in a 9-day open detoxification trial. Characterization of subjective, objective and psychological opioid withdrawal symptoms was performed through an evaluation of the time course (days 0-8) of single items of a 27 items rating scale. Buprenorphine resulted to be an active and well tolerated drug
Revue / Journal Title
Regulatory peptides ISSN 0167-0115 CODEN REPPDY
Source / Source
Congrès
INRC : international narcotics research conference No24, Skövde , SUEDE (10/07/1993)
1994, SUP1 (4 ref.), pp. S289-S290
Langue / Language
Anglais
Editeur / Publisher
Elsevier, Amsterdam, PAYS-BAS (1980) (Revue)
Mots-clés anglais / English Keywords
Drug addiction ; Withdrawal syndrome ; Deintoxication ; Treatment ; Chemotherapy ; Human ; Opiates ;
Mots-clés français / French Keywords
Toxicomanie ; Sevrage syndrome ; Désintoxication ; Buprénorphine ; Traitement ; Chimiothérapie ; Homme ; Opiacés ;
Mots-clés espagnols / Spanish Keywords
Toxicomanía ; Destete síndrome ; Desintoxicación ; Tratamiento ; Quimioterapia ; Hombre ; Opiados ;
Localisation / Location
INIST-CNRS, Cote INIST : 18854, 35400004933769.1410
|Buprenorphine versus dihydrocodeine for opiate detoxification in primary care: a randomised controlled trial |
|Nat MJ Wright1 [pic], Laura Sheard1 [pic], Charlotte NE Tompkins1 [pic], Clive E Adams2 [pic], Victoria L Allgar1 [pic]and Nicola S Oldham3 |
|[pic] |
|1Centre for Research in Primary Care, 71-75 Clarendon Road, Leeds, LS2 9PL, UK |
|2Department of Psychiatry, 15 Hyde Terrace, Leeds, LS2 9L, UK |
|3Formerly of NFA Health Centre for Homeless People, 68 York Street, Leeds, LS9 8AA, UK |
|[pic]author email[pic] corresponding author email |
|BMC Family Practice 2007, 8:3doi:10.1186/1471-2296-8-3 |
|The electronic version of this article is the complete one and can be found online at: |
|Received: |
|16 May 2006 |
| |
|Accepted: |
|8 January 2007 |
| |
|Published: |
|8 January 2007 |
| |
|© 2007 Wright et al; licensee BioMed Central Ltd. |
|This is an Open Access article distributed under the terms of the Creative Commons Attribution License |
|(), which permits unrestricted use, distribution, and reproduction in any medium, provided the |
|original work is properly cited. |
|Abstract |
|Background |
|Many drug users present to primary care requesting detoxification from illicit opiates. There are a number of detoxification agents but no |
|recommended drug of choice. The purpose of this study is to compare buprenorphine with dihydrocodeine for detoxification from illicit |
|opiates in primary care. |
|Methods |
|Open label randomised controlled trial in NHS Primary Care (General Practices), Leeds, UK. Sixty consenting adults using illicit opiates |
|received either daily sublingual buprenorphine or daily oral dihydrocodeine. Reducing regimens for both interventions were at the discretion|
|of prescribing doctor within a standard regimen of not more than 15 days. Primary outcome was abstinence from illicit opiates at final |
|prescription as indicated by a urine sample. Secondary outcomes during detoxification period and at three and six months post detoxification|
|were recorded. |
|Results |
|Only 23% completed the prescribed course of detoxification medication and gave a urine sample on collection of their final prescription. |
|Risk of non-completion of detoxification was reduced if allocated buprenorphine (68% vs 88%, RR 0.58 CI 0.35–0.96, p = 0.065). A higher |
|proportion of people allocated to buprenorphine provided a clean urine sample compared with those who received dihydrocodeine (21% vs 3%, RR|
|2.06 CI 1.33–3.21, p = 0.028). People allocated to buprenorphine had fewer visits to professional carers during detoxification and more were|
|abstinent at three months (10 vs 4, RR 1.55 CI 0.96–2.52) and six months post detoxification (7 vs 3, RR 1.45 CI 0.84–2.49). |
|Conclusion |
|Informative randomised trials evaluating routine care within the primary care setting are possible amongst drug using populations. This |
|small study generates unique data on commonly used treatment regimens. |
|Background |
|In the United Kingdom (UK), policy directives have highlighted the importance of offering either maintenance or detoxification to illicit |
|opiate users within an agreed plan of care [1]. This is in response to routine practice by some treatment providers of 'gradual reduction' |
|of opiate maintenance treatment – a regimen without a supporting evidence base [2]. Opiate detoxification, using one of various therapeutic |
|agents, remains an important part of drug management for some illicit opiate users. However, neither the evidence base nor UK national |
|guidelines recommend a 'drug of choice' [1]. Understandably, there has been a call for randomised controlled trials (RCTs) in this area [3].|
|In primary care, methadone is commonly used, with reductions in the dose over 7–21 days [4]. Methadone has a long half life [5,6] and |
|patients often report distressing withdrawal symptoms in the latter stages of detoxification [6]. This has meant increasing use of |
|alternative agents such as clonidine, lofexidine, dihydrocodeine and, more recently, buprenorphine. The hypotensive effects of clonidine [4]|
|have make it unacceptable for use in primary care and the reduced ability of lofexidine to control withdrawal, coupled with its high cost |
|have resulted in limited clinical uptake [4]. |
|The use of sublingual buprenorphine is relatively new in the UK for opiate detoxification and there have been only two randomised controlled|
|trials (RCTs) comparing it with methadone for this purpose [7,8]. Buprenorphine has been more commonly used as a drug of comparison in |
|trials of opiate maintenance [9-16]. A recent Cochrane review assessing methadone and buprenorphine for the management of opioid withdrawal |
|found no significant difference between these two agents [17]. In this context, buprenorphine has a good safety profile, better retention in|
|treatment and lower withdrawal severity [18-22]. Sublingual buprenorphine is increasingly being prescribed by General Practitioners (GPs) |
|for opiate detoxification [23] despite limited clinical and research evidence. |
|Dihydrocodeine has a shorter half life than methadone and has been widely used in both primary care and prison drug treatment settings for |
|opiate detoxification. Whilst some commentators have documented success with dihydrocodeine [24,25] others have expressed concerns regarding|
|its effects, particularly the potential diversion into the street economy [26]. Despite routine use, dihydrocodeine has rarely been studied |
|for the purposes of opiate detoxification [24] but has been compared in a randomised controlled trial with buprenorphine for postoperative |
|pain [27]. |
|When comparing methadone, dihydrocodeine and buprenorphine it is important to note several factors which may impact upon prescribing and use|
|of these agents. Dihydrocodeine is cheaper than methadone and both methadone and dihydrocodeine are substantially cheaper than |
|buprenorphine. The latter has been subject to heavy pharmaceutical marketing. Buprenorphine and dihydrocodeine have a better safety profile |
|than methadone, which has a high toxicity which (rarely) can result in death [28]. All three agents have the potential for street diversion |
|but dihydrocodeine is the hardest to control, with consumption usually being unsupervised. Methadone is the easiest to manage and |
|buprenorphine seems to be somewhere in-between. |
|The care of people using illicit opiates has changed over recent years. Strang et al (2005) [29] surveyed GPs and found that half had seen |
|at least one opiate user in a four week period, compared to only 19% in a 1986 survey [30]. There has been a significant increase in the |
|number of GPs becoming involved in the care of drug users [31]. Consequently, many short term opiate detoxifications are now undertaken in |
|primary care. The absence of robust evidence underpinning many of the clinical decisions made within primary care has already been |
|highlighted [32]. LEEDS (Leeds Evaluation of Efficacy of Detoxification Study) is a response to this challenge and compared dihydrocodeine |
|with buprenorphine for opiate detoxification within the UK primary care setting. |
|Methods |
|Design and setting |
|LEEDS was conducted in ten general practices (6 of which randomised participants) in Leeds, UK (population ~750,000). We used a randomised |
|controlled trial design to compare open giving of oral dihydrocodeine tartrate with open giving of sublingual buprenorphine. Randomisation |
|was by random block size, stratified by practice, using Microsoft Excel RAND function. This was undertaken by the Department of Psychiatry, |
|University of Leeds, and was concealed from clinicians prescribing interventions. The name of the allocated intervention was obscured within|
|fully opaque sealed envelopes [33]. All envelopes were opened in strict order, confirmed by an investigator independent of the clinical |
|interface. The outside of the randomisation envelope contained a brief information form to be completed which requested the patient's |
|practice number, date of birth, contact telephone number and date of first prescription. Two questions also served to rate the severity of |
|addiction of the participant from the view of the GP. Once the GP/drug worker opened the LEEDS envelope both practitioner and patient knew |
|the intervention, standard clinical care resumed and the patient made subsequent appointments with the GP and/or drugs worker. To detect |
|with 80% power a difference in treatment effectiveness of 25% between groups (50% versus 25%) at 5% level of significance, it was calculated|
|that 120 participants would be needed in the study. However within the time frame for recruitment we were only able to recruit 60 |
|participants. Randomisation took place between August 2002 and May 2004. Full methods are reported elsewhere [33]. |
|The Leeds Teaching Hospitals Local NHS Research Ethics Committee (LREC) approved the study in April 2002. Informed written consent was |
|obtained from each patient following receipt of a participant information leaflet prior to their involvement in the trial. |
|Interventions |
|Buprenorphine was prescribed on an FP10 MDA prescription. This allows daily dispensing under supervision of a pharmacist. Daily supervised |
|administration of dihydrocodeine tablets is not possible in the UK as it cannot be prescribed on FP10 MDA prescriptions. As such, |
|buprenorphine was dispensed either as 8 mg, 2 mg or 0.4 mg sublingual tablet preparation under daily supervision. Dihydrocodeine was |
|dispensed as 30 mg rapid release tablet preparation in take home installments. Each installment was for a minimum of three and a maximum of |
|4 daily doses. The reducing regimens for both interventions were at the discretion of the prescribing doctor and within the standard regimen|
|which was approximately 15 days (Tables 1 and 2). However, clinicians were free to titrate doses against withdrawal symptoms. What was being|
|randomised was the open giving of the drugs even if that meant that participants were not given in the opinion of the prescribing doctor |
|pharmacologically equivalent dosages. |
|Table 1. Standard buprenorphine detoxification |
|Table 2. Standard dihydrocodeine detoxification |
|Inclusion and exclusion criteria |
|Patients were eligible for the study if they were: aged 18 years or over, using street opiates as confirmed by a urine sample taken at first|
|assessment, wishing to detoxify through the standard monitored process, willing to remain abstinent from opiates and to give informed |
|consent. Patients were excluded if they had contra-indications to dihydrocodeine or buprenorphine or had been randomised into the trial |
|previously. |
|Outcomes |
|The primary outcome was abstinence from illicit heroin at final prescription, as indicated by urine test. A priori we classed unsuccessful |
|detoxification as: the final urine tested positive for metabolic breakdown products of heroin (morphine or 6-mono-acetyl morphine); urine |
|tested positive for opiates commonly found in street heroin (codeine); the patient did not provide a final urine sample; did not finish |
|detoxification or reported using street opiates during the period of detoxification. We recorded the secondary outcomes of inappropriate use|
|of prescribed medication, overdose and admission to hospital or Accident and Emergency (A&E) and number of GP/drug worker visits during the |
|detoxification period. At three and six month post detoxification, follow up data were recorded. These outcomes were: whether the person was|
|still alive, abstinent from opiates, in receipt of sickness certification and their pattern of service use. |
|Statistical analysis |
|Outcome data were analysed using Epi Info v 3.3.2 and SPSS software with relative risk tests for categorical data and unpaired t-tests for |
|continuous data. |
|Results |
|Sixty people using illicit opiates took part in LEEDS (Figure 1). This comprised of 42 men and 18 women, with an average age of 28 years. |
|58% were homeless or unstably housed. There were no significant differences for those allocated to one regimen or the other (Table 3). |
|[pic]Figure 1. |
|Table 3. Demographic characteristics and prognostic factors |
|Overall, only 13 people (23%) completed the prescribed course of detoxification medication and gave a urine sample on collection of their |
|final prescription (Table 4). There was an increased chance of completing the prescribing regime if allocated buprenorphine though this |
|finding was of borderline statistical significance (68% vs 88%, RR 0.58 CI 0.35–0.96, p = 0.065). At completion of detoxification, by |
|intention to treat analysis we found a higher proportion of people allocated to buprenorphine provided a urine sample negative for opiates |
|(abstinent) compared with those who received dihydrocodeine (21% vs 3%, RR 2.06 CI 1.33–3.21, p = 0.028). This suggestion of an enhanced |
|therapeutic effect with buprenorphine was negated if we assumed that the proportions of those returning with clean urine per group were |
|representative of those who did not return. Had all the medication been both prescribed and dispensed according to the standard regimes, an |
|expected mean prescribed dose for each dihydrocodeine detoxification would be 4560 mg and 56 mg for each buprenorphine dose. The actual |
|amount of milligrams (mean) and duration of detoxification in days (mean) prescribed for each dihydrocodeine detoxification was 4111 mg (90%|
|of expected dose) over 12 days and 32.9 mg (59% of expected dose) of buprenorphine over 9 days (both rounded to nearest day). This would |
|indicate under-prescribing by doctors for both regimes as 4290 mg (94% of expected dose) would have expected to be prescribed over 12 days |
|for dihydrocodeine and 47.6 mg (85% of expected dose) over 9 days for buprenorphine. |
|Table 4. Results |
|There was no statistically significant differences for any other outcomes although throughout the trial people allocated to buprenorphine |
|did better than those on dihydrocodeine. For example people allocated to buprenorphine had fewer visits to the GP and drugs worker during |
|detoxification, and more were abstinent at the three month (10 vs 4, RR 1.55 CI 0.96–2.52) and six month (7 vs 3, RR 1.45 CI 0.84–2.49) |
|follow up. These findings were of borderline statistical significance. No serious adverse events were reported for any participants. |
|Discussion |
|Commentators have listed significant barriers to conducting randomised controlled trials in the primary care setting [34,35]. Barriers |
|certainly may include lack of clinical equipoise towards interventions and patient preference for a particular treatment, [36] as well as |
|logistical problems (principally the busy primary care workplace as not being conducive to practitioner participation) and over-optimism |
|regarding recruitment [37]. This study, however, was at the outset designed collaboratively between primary care and secondary care |
|researchers to be conducted specifically in the primary care setting. It did not greatly complicate routine treatment and recorded clear and|
|concrete outcomes of relevance to the primary care drug treatment field [33]. The LEEDS project team sought GPs experience of being involved|
|in the trial through a cross sectional survey. Details of the practicalities of conducting LEEDS (including recruitment issues and |
|equipoise) have been fully described elsewhere [38]. |
|LEEDS is the first randomised controlled trial to compare buprenorphine and dihydrocodeine for opiate detoxification. Sixty people with |
|problems of opiate dependence agreed to take part in this randomised trial. Thirty five of these people were recruited from a medical centre|
|for the homeless. Recruitment of practitioners was problematic though recruitment of participants was not a substantial problem for |
|practitioners committed to recruiting into the trial. This study ran on a very low budget (50% research assistant time). LEEDS illustrates |
|how such studies, undertaken in the context of routine care, even with such potentially problematic clientele, are both possible and |
|feasible. |
|One limitation of LEEDS was that it was underpowered to detect with confidence clear differences for secondary outcomes between regimens. |
|Selecting a data collection point for the primary outcome at completion of detoxification could be seen as a limitation of the study. |
|However, this outcome was selected after careful consideration. Ideally urine collection would be several days post-detoxification to allow |
|for all prescribed opiates to be clear from the test. We thought, however, many users would not attend primary care after completion of |
|detoxification simply to provide a urine test, particularly as much of the recruitment was from a homeless population who have been |
|traditionally difficult to engage and retain in treatment services [39]. Indeed, only 23% of participants provided a final urine sample. |
|Reasons for this are varied and multiple (Figure 1). Fourteen people did not collect their final prescription and therefore were not |
|available at this time point to provide a urine sample. Five people never returned to the GP practice to collect any prescriptions after |
|their first consultation with the GP or drugs worker. Additionally, 24 people failed to collect a prescription somewhere between the second |
|and penultimate. The high numbers of people who did not provide a urine sample demonstrates the difficulty in retaining injecting drug users|
|in treatment services. This pragmatic, low budget study only sought to record contact with GPs and drugs workers and did not have sufficient|
|capacity to make personal contact during the detoxification period to obtain abstinence status independent of that recorded through medical |
|contact. |
|The main objectives of LEEDS were to have some indication of whether one regimen was associated with better odds of completing |
|detoxification and to test methods for larger studies. We recognize that these are limited goals but found no indication from the literature|
|or even experts in the field that data was known for these outcomes. Of course, retention in treatment services post-detoxification is an |
|important part of the whole treatment package offered to drug users so we also recorded the frequency of medical service utlisation by |
|participants. |
|An additional limitation of the study is that we were unable to collect data on the numbers and demographics of those people who declined to|
|participate. This was due to the busy nature of the primary care treatment setting. |
|Currently many drug users arrested for crimes related to drug misuse are offered a choice of legally mandated treatment (referred to by some|
|as 'coerced' treatment) [40] or a custodial sentence. No participant in LEEDS had been legally mandated to enter treatment from the criminal|
|justice system. Consequently, all participants expressed self motivation to undergo detoxification. Yet, regardless of which detoxification |
|drug people were randomised to, completion rates were poor. This study suggests that even in this relatively self motivated group of people,|
|completion rates were between only 13% and 32%. In secondary care others have reported completion rates in the range of 33% [41]. However |
|comparisons with study retention rates from trials undertaken in secondary care should be made with caution as it is possible that |
|participants were not equivalent in terms of motivation and self-efficacy. More evaluation of treatment effects in different health settings|
|would therefore seem prudent and we have nearly completed a larger study in the prison setting. The results of this current study, however, |
|are generalisable to those patients presenting for detoxification from illicit opiates in primary care. We would be less confident of |
|generalising our findings to the residential or inpatient setting. |
|This trial suggests that buprenorphine may be able to deliver 20% more completion than dihydrocodeine. If completion of detoxification is |
|associated with remaining abstinent, use of buprenorphine as an agent of opiate detoxification could be a very important step forward. |
|Whilst clinicians prescribing the interventions were not blinded beyond the point of randomisation, the difference favouring buprenorphine |
|could be due to increased professional input for that intervention. However there was no evidence to suggest that this was the case. Rather,|
|there was no suggestion of a difference in GP/drug worker visits between the two groups. LEEDS was a "real-world" trial with a pragmatic |
|rather than explanatory design. As such it randomised interventions which are used in everyday clinical practice. Previous commentators have|
|spoken about the need to balance issues of methodological rigour (commonly referred to as internal validity) versus the feasibility of |
|conducting trials in the real world clinical environment (commonly referred to as external validity) [42]. Inevitably there is a trade off |
|between rigour and feasibility. For example in this case whilst the use of dummy pills was considered at the design stage, it was deemed |
|unfeasible as it would both add to the cost of the research and also limit the independence of the trial from pharmaceutical company |
|funding. |
|It could also be argued that the superior percentage of those achieving abstinence as a result of the buprenorphine intervention was because|
|mean buprenorphine and dihydrocodeine doses were not equivalent in terms of the pharmacological opiate effect. However this is not possible |
|to verify as the two interventions are not identical in terms of action on opiate receptors. Buprenorphine has the unusual property of being|
|both a partial MU receptor (one of a number of opiate receptors) agonist and partial opiate antagonist whereas dihydrocodeine is a full |
|opiate receptor agonist. |
|Conclusion |
|Only 23% of participants completed their detoxification and gave a final urine sample. This finding suggests a high non-completion rate of |
|primary care opiate detoxifications. A higher proportion of people randomised to buprenorphine provided a final urine sample negative for |
|illicit opiates compared with those who received dihydrocodeine. Those allocated buprenorphine made fewer visits to the GP and drugs worker |
|during detoxification. Additionally, more of those allocated buprenorphine were abstinent at three and six months post detoxification when |
|compared to the dihydrocodeine group. |
|Currently in some treatment services in the UK the open giving of dihydrocodeine has continued despite an absence of evidence to support its|
|clinical effectiveness. More recently, there has been a marked increase in the prescribing of buprenorphine in the UK [23]. Such an increase|
|is in line with emerging best practice primary care guidance based primarily upon face validity for opiate detoxification. This guidance |
|supports the use of buprenorphine but not dihydrocodeine for opiate detoxification in the primary care setting [43]. The LEEDS findings |
|begin to support this guidance with good evidence but there is some way to go before fully confident recommendations can be made. |
|The findings will also have relevance to any review of current Department of Health best practice guidelines for the treatment of substance |
|misuse [4]. Launched in 1999, they argued that GP prescribing of buprenorphine requires a greater level of clinical experience than the |
|prescribing of dihydrocodeine. The guidelines recommend buprenorphine should only be given by a "specialist general practitioner" and |
|dihydrocodeine by an "experienced" GP [4]. LEEDS provides little evidence to support the continued prescribing of dihydrocodeine as a first |
|line agent for opiate detoxification by less experienced GPs in primary care, but larger, well designed, conducted and reported trials are |
|necessary. |
|Competing interests |
|The author(s) declare that they have no competing interests. |
|Authors' contributions |
|NW and CA designed the study, offered project supervision and drafted the manuscript. NW was principal investigator. CA centrally managed |
|the randomisation process and conducted statistical analysis. LS coordinated and managed the project during the latter stages, collected |
|data and drafted the manuscript. CT conducted data collection and drafted the manuscript. VA conducted statistical analysis and commented on|
|the results section. NO was the initial project coordinator, who assisted in the design of the study and collected data. All authors have |
|read and approved the final manuscript. |
|Funding body |
|Leeds Primary Care Trusts Research Consortium Priorities and Needs Funding. |
|Ethics committee |
|Leeds Teaching Hospitals Local Research Ethics Committee. |
|Acknowledgements |
|We are grateful to all patients at surgeries in Leeds who participated in the trial. We would particularly like to thank Drs Paul Glynn, |
|Sally Read and Will Bolland, drug workers and reception. |
|Staff who form the LEEDS project collaborative. We also thank Leeds Primary Care Trusts Research Consortium Priorities and Needs Funding who|
|funded the project. |
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Methadone detoxification of tramadol dependence . Journal of Substance Abuse Treatment , Volume 19 , Issue 3 , Pages 297 - 299 R . Leo
|bstract |
| | |Tramadol hydrochloride is a centrally acting analgesic with a partial affinity |
| | |for the opiate receptor (μ), having an analgesic potency estimated to be one |
| | |tenth that of morphine. While preclinical investigations suggested that abuse |
| | |liability associated with tramadol use is low, there are increasing numbers of |
| | |cases reported to the U.S. Food and Drug Administration of abuse, dependence, |
| | |and withdrawal associated with tramadol use. A case of a patient with tramadol |
| | |dependence requiring detoxification with methadone is presented. Acute |
| | |management of significant tramadol dependence has not yet been reported in the |
| | |literature. Long-term treatment issues are also discussed. |
Differences in heroin addicts seeking inpatient detoxification, ambulatory detoxification, or methadone maintenance.
Steer RA.
Fifteen psychosocial characteristics of 300 male and 90 female heroin addicts admitted for inpatient detoxification, ambulatory detoxification, and methadone maintenance within the same multiphasic drug-abuse program were compared to determine whether or not their characteristics differentiated those seeking each type of treatment approach; there were 100 men and 30 women randomly drawn to represent each of the three approaches. Only two variables differed among the three approaches for both men and women--length of daily heroin use and educational attainment. The ambulatory detoxification patients had started using heroin daily at a later age than the inpatients who, in turn, had started using heroin daily at a later age than the methadone maintenance patients, and the ambulatory detoxification patients were more educated than the inpatients. The other variables differentiating the three approaches for each sex were discussed, and the conclusion was drawn that addicts with higher socioeconomic levels preferred ambulatory detoxification over methadone maintenance.
PMID: 510180 [PubMed - indexed for MEDLINE]
Suspected determinants of enrollment into detoxification and methadone maintenance treatment among injecting drug users.
Schütz CG, Rapiti E, Vlahov D, Anthony JC.
National Institute on Drug Abuse/Intramural Research Program, Etiology Branch, Baltimore, MD 21224.
Our primary aim in this study has been to evaluate selected conditions thought to influence the entry of injecting drug users (IDU) into detoxification and methadone maintenance programs, making use of a prospective study design to strengthen a cross-sectional investigation of these conditions. To begin our investigation, we analyzed cross-sectionally gathered data on 2879 IDUs who had been recruited through extensive community outreach efforts and who were interviewed at the time of recruitment. We then tested our hypotheses about suspected determinants of entry into treatment by analyzing prospectively gathered data on 1039 active drug users who had no recent history of being treated for drug problems. Among these 1039 IDUs (a subset of the initial cross-sectional sample), 144 entered a detoxification program between their recruitment interview and their next follow-up interview, conducted about six months after recruitment (range: 3.5-9.5 months) and 64 entered a methadone maintenance program during that observation interval. Using multiple logistic regression analyses, we found that a recent drug overdose, relatively higher frequency of injecting drugs, and a history of prior arrest or treatment were independent predictors of entry into detoxification. Being married or living with a partner, being female, a lengthy duration of drug use (> 10 years), and a history of prior treatment were independent predictors of entry into methadone maintenance. These findings shed light on what appears to be a different profile of suspected determinants of entry into a detoxification treatment versus methadone maintenance treatment, and help to clarify some potential differences between treated and untreated drug users that ought to be considered when evaluating results of investigations with IDU participants recruited solely from treatment settings.
PMID: 7851280 [PubMed - indexed for MEDLINE]
Symptoms discriminating between heroin addicts seeking ambulatory detoxification or methadone maintenance.
Steer RA.
The self-report symptom inventory, SCL-90-R, was administered to 240 heroin addicts seeking ambulatory detoxification and 240 requesting methadone maintenance. Controlling for age, a stepwise discriminant analysis employing a backward elimination model was performed with the SCL-90-R's nine symptom factors to determine if the addicts described different levels of symptomatology. Interpersonal sensitivity and depression differentiated between the two groups; the ambulatory detoxification patients were more depressed and described less interpersonal sensitivity than the methadone maintenance patients. The results supported the contention that heroin addicts seeking ambulatory detoxification or methadone maintenance may display different symptoms.
PMID: 7128452 [PubMed - indexed for MEDLINE]
Ability to remain abstinent after methadone detoxification. A six-year study
B. Stimmel, J. Goldberg, E. Rotkopf and M. Cohen
Three hundred thirty-five persons successfully detoxified from methadone hydrochloride maintenance were followed up for as long as six years to determine their ability to remain abstinent from narcotic use. At the end of the observation period, of the 269 persons located, 35% were narcotic-free, 58% had returned to narcotic use, and 8% were either jailed or deceased. The ability of a person to refrain from narcotic use was found to be highly associated with staff's assessment of progress and duration of methadone maintenance treatment. Relapse to narcotic use occurred regardless of length of abstinence, with 35% of relapses occurring after three or more years. While abstinence after narcotic dependency is possible, it is not a realistic goal for all. Premature detoxification from methadone maintenance is associated with a high recidivism rate to narcotics.
J Subst Abuse Treat. 2000 Oct ;19 (3):301-5 11027902 (P,S,G,E,B)
Dihydrocodeine: a useful tool in the detoxification of methadone-maintained patients.
[My paper] J Banbery, K Wolff, D Raistrick
Leeds Addiction Unit, 19 Springfield Mount, LS2 9NG, Leeds, UK.
We investigated the merit of dihydrocodeine tartrate for withdrawal in detoxifying 20 methadone-maintained patients presenting for treatment at the Leeds Addiction Unit (LAU). Thirteen patients (65%) successfully completed methadone detoxification and were abstinent from both methadone and opiate-type drugs at the end of the 2-week program. On completion, three patients began treatment with Naltrexone and another was abstinent at a follow-up appointment, 1 week later. A further patient relapsed back to heroin use but remained in contact with the LAU. The remaining six patients dropped out of the 2-week detoxification program between days 3 and 11 of the dihydrocodeine cross-over period. We believe dihydrocodeine may have advantages in detoxifying methadone-maintained patients.
Mesh-terms: Methadone :: administration & dosage; Adolescent; Adult; Analgesics, Opioid :: administration & dosage; Codeine :: administration & dosage; Codeine :: analogs & derivatives; Comparative Study; Cross-Over Studies; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Human; Male; Opioid-Related Disorders :: rehabilitation; Retrospective Studies; Treatment Outcome;
Other papers by authors
CKS adresse ===
▪ It is important that there is a clear distinction between maintenance and detoxification so that the person does not slip between the two. This may occur if the reduction rate is too slow and the person becomes unstable on the reduced dose. It is important to avoid a situation whereby a lower level of substitute drug is reached and the user stays on this dose long-term using illicit drugs 'on top' and therefore failing to achieve their detoxification goals. In this situation, increase the dose of methadone until illicit drug use has stopped, and then restart a slow reduction in methadone dose.
▪ At the later stages of detoxification, symptomatic treatments, such as anti-diarrhoeal medication, nonsteroidal anti-inflammatory drugs, hypnotics, or anxiolytics, may be helpful. Advise that the person may feel withdrawal symptoms 2–3 days after stopping the final dose (due to the long half-life of methadone).
▪ Detoxification with buprenorphine for the final stages may be preferred. Switch to buprenorphine when a daily dose of 30 mg methadone has been reached and the person is stabilized (see Starting maintenance treatment with buprenorphine). Once stable on buprenorphine, the person should remain on that dose for 2–3 days and then the dose of buprenorphine may be reduced by 2 mg per day over 5–10 days. A more rapid detoxification regimen should only be attempted after specialist advice.
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