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Sustained-release naltrexone for opioid dependence
Hege Kornør1, Philipp Paul K Lobmaier2, Nikolaj Kunøe3,4
1Norwegian Centre for Sports and Mental Health, Oslo, Norway.
The Cochrane Database of Systematic Reviews
|May 9, 2025
Summary
Sustained-release naltrexone (SRN) shows mixed results for opioid dependence treatment. While it reduces illicit opioid use compared to treatment as usual, it may increase use and adverse events versus opioid agonists, with uncertain benefits over placebo or oral naltrexone.
Area of Science:
- Pharmacology and Addiction Medicine
- Evidence-Based Medicine
- Clinical Trial Analysis
Background:
- Opioid dependence is a chronic disorder with significant mortality and psychosocial burdens.
- Sustained-release naltrexone (SRN) offers a long-acting opioid antagonist treatment option.
- SRN formulations include monthly injections and longer-lasting implants (up to six months).
Purpose of the Study:
- To systematically assess the benefits and harms of sustained-release naltrexone (SRN) for treating opioid dependence.
- To synthesize evidence from randomized controlled trials comparing SRN with various control groups.
Main Methods:
- Comprehensive database searches (2007-2023) identified 22 randomized controlled trials (3416 participants).
- Studies compared injectable or implantable SRN against opioid agonist treatment, oral naltrexone, placebo, treatment as usual, or psychosocial interventions.
- Primary outcomes included illicit opioid use, treatment retention, acceptability, and adverse events, analyzed using meta-analysis and GRADE certainty assessment.
Main Results:
- Compared to treatment as usual, SRN significantly reduced illicit opioid use (high-certainty evidence) and probably reduced serious adverse events (moderate-certainty evidence).
- SRN may slightly increase illicit opioid use and serious adverse events compared to opioid agonist treatment (low-to-moderate certainty).
- Evidence for SRN versus oral naltrexone or placebo showed mixed results, often with low certainty or uncertainty regarding treatment retention and acceptability.
Conclusions:
- Sustained-release naltrexone demonstrates effectiveness in reducing illicit opioid use and potentially serious adverse events when compared to treatment as usual.
- Evidence suggests SRN may be less effective than opioid agonist treatment regarding illicit opioid use and adverse events, with uncertain comparative benefits over oral naltrexone or placebo.
- Significant research gaps exist, necessitating larger, higher-quality studies, investigations into different formulations, long-term outcomes, and diverse populations, including synthetic opioid users.
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