Evidence map›Paper›PMID 16461865›Full record

Trial reportArchives of general psychiatry2006

Injectable, sustained-release naltrexone for the treatment of opioid dependence: a randomized, placebo-controlled trial.

Sandra D Comer, Maria A Sullivan, Elmer Yu, Jami L Rothenberg, Herbert D Kleber, Kyle Kampman, Charles Dackis, Charles P O'Brien

Registry-linked trialAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Archives of general psychiatry, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03678792 (Time to Detox), which is not on this map. Cited by 170 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
170citing papers in PubMed, 11 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03678792 phase3withdrawnnot on this mapstarted 2019, after this paper: background citation

Time to Detox: A Patient-Centered Comparison of Length of Detoxification Treatment and Time to Naltrexone Maintenance Therapy in Opioid-Dependent Individuals

TypeinterventionalSponsorUniversity of Alabama at BirminghamRan2019 to 2020Enrolled0ConditionsOpioid-Related Disorders, Opioid WithdrawalArmsBuprenorphine/naloxone, Morphine, Tramadol
3 · Its place in the literature

Who cites it

170 citing papers in PubMed, 11 syntheses or guidelines pooled it.

  1. Sustained-release naltrexone for opioid dependence.The Cochrane database of systematic reviews · 2025
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  9. Opioid dependence.BMJ clinical evidence · 2011
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  10. Opioid dependence.BMJ clinical evidence · 2009
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  11. Sustained-release naltrexone for opioid dependence.The Cochrane database of systematic reviews · 2008
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110 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors.

Sandra D ComerDivision on Substance Abuse, New York State Psychiatric Institute, and Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York 10032, USA. sdc10@columbia.edu
Maria A Sullivan
Elmer Yu
Jami L Rothenberg
Herbert D Kleber
Kyle Kampman
Charles Dackis
Charles P O'Brien

Funding

PHARMACOLOGICAL TREATMENT OF MARIJUANA DEPENDENCEP50DA009236 · NIDA · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · PI KLEBER, HERBERT DAVID · 1994 to 2013
$39.4M
TREATMENT STRATEGIES FOR METHODONE NONRESPONDERSP60DA005186 · NIDA · UNIVERSITY OF PENNSYLVANIA · PI O'BRIEN, CHARLES P · 1997 to 2012
$28.1M
NCI NIH HHS P60 CA05186NIDA NIH HHS N01DA-1-8817NIDA NIH HHS N01DA-3-8829NIDA NIH HHS P50 DA009236NIDA NIH HHS P50 DA09236NIDA NIH HHS P60 DA005186
6 · The paper itself

Abstract

contextOral naltrexone can completely antagonize the effects produced by opioid agonists. However, poor compliance with naltrexone has been a major obstacle to the effective treatment of opioid dependence.

objectiveTo evaluate the safety and efficacy of a sustained-release depot formulation of naltrexone in treating opioid dependence. DESIGN AND

settingRandomized, double-blind, placebo-controlled, 8-week trial conducted at 2 medical centers.

participantsSixty heroin-dependent adults.

interventionsParticipants were stratified by sex and years of heroin use (> or = 5 vs < 5) and then were randomized to receive placebo or 192 or 384 mg of depot naltrexone. Doses were administered at the beginning of weeks 1 and 5. All participants received twice-weekly relapse prevention therapy, provided observed urine samples, and completed other assessments at each visit.

main outcome measuresRetention in treatment and percentage of opioid-negative urine samples.

resultsRetention in treatment was dose related, with 39%, 60%, and 68% of patients in the placebo, 192 mg of naltrexone, and 384 mg of naltrexone groups, respectively, remaining in treatment at the end of 2 months. Time to dropout had a significant main effect of dose, with mean time to dropout of 27, 36, and 48 days for the placebo, 192 mg of naltrexone, and 384 mg of naltrexone groups, respectively. The percentage of urine samples negative for opioids, methadone, cocaine, benzodiazepines, and amphetamine varied significantly as a function of dose. When the data were recalculated without the assumption that missing urine samples were positive, a main effect of group was not found for any drugs tested except cocaine, where the percentage of cocaine-negative urine samples was lower in the placebo group. Adverse events were minimal and generally mild. This formulation of naltrexone was well tolerated and produced a robust, dose-related increase in treatment retention.

conclusionThese data provide new evidence of the feasibility, efficacy, and tolerability of long-lasting antagonist treatments for opioid dependence.

Indexed as

AdolescentAdultCocaineDelayed-Action PreparationsDouble-Blind MethodDrug Administration ScheduleFemaleHeroin DependenceHumansInjections, SubcutaneousMaleMethadoneMiddle AgedNaltrexoneNarcoticsPlacebosCocaineDelayed-Action PreparationsMethadoneNaltrexoneNarcoticsPlacebos

Identifiers

PMID16461865
PMCPMC4200530

What OpenQuestion holds

Textmetadata
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.