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Sustained-release naltrexone for opioid dependence.

P Lobmaier¹, H Kornør, N Kunøe

¹University of Oslo, Norvegian Centre for Addiction Research, Kirkeveien 166, Oslo, Norway, 0407. p.p.lobmaier@medisin.uio.no

The Cochrane Database of Systematic Reviews

|April 22, 2008

Summary

This summary is machine-generated.

Sustained-release naltrexone injections may increase treatment duration for opioid dependence, but evidence is limited. Adverse effects were more frequent with naltrexone depot compared to placebo.

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Area of Science:

Pharmacology and Addiction Medicine
Clinical Trials and Evidence Synthesis

Background:

Naltrexone, an opioid antagonist, is used for heroin dependence.
Oral naltrexone treatment has high dropout rates, prompting investigation into sustained-release formulations like depot injections and implants.
A systematic review of sustained-release naltrexone's effectiveness is lacking.

Purpose of the Study:

To systematically review the effectiveness of sustained-release naltrexone for opioid dependence.
To evaluate the adverse effects of sustained-release naltrexone across different populations (opioid-dependent, alcohol-dependent, healthy volunteers).

Main Methods:

Comprehensive literature search of multiple databases (inception to November 2007) and manual searches of reference lists and proceedings.
Inclusion of randomized controlled trials (RCTs) for effectiveness and any clinical trials reporting adverse effects.
Independent data extraction and quality assessment by reviewers, with separate analyses for different participant groups.

Main Results:

One RCT indicated high-dose naltrexone depot injections (384 mg) significantly increased treatment duration compared to placebo and low-dose.
No significant differences in patient retention rates were observed between groups.
Seventeen reports on adverse effects found them to be more frequent with naltrexone depot than placebo, particularly in alcohol-dependent samples; however, systematic assessment was scarce.

Conclusions:

Insufficient evidence exists to confirm the effectiveness of sustained-release naltrexone for opioid dependence treatment.
Naltrexone injections are associated with frequent, moderate, and time-limited administration site adverse effects.
More data on side effects and adverse events are required for a comprehensive harm-benefit evaluation of naltrexone implants.