Journal
ADDICTION
Volume 108, Issue 9, Pages 1628-1637Publisher
WILEY
DOI: 10.1111/add.12208
Keywords
Craving; depot naltrexone; extended-release naltrexone; heroin dependence; injectable naltrexone; opioid dependence; long-term safety; naltrexone; sustained release formulations
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Funding
- Alkermes, Inc.
- National Institute on Drug Abuse [R43DA013531]
- National Institute on Alcohol Abuse and Alcoholism [N43AA001002]
- Alkermes
- Titan Pharmaceuticals
- Hythiam
- Reckitt Benckiser
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Aims To describe drug use and safety with intramuscular injectable extended-release naltrexone (XR-NTX) in opioid dependence during a 1-year open-label extension phase. Design Following 6 months of randomized, double-blind, placebo (PBO)-controlled injections given every 28 days, patients receiving XR-NTX 380 mg continued and PBO patients were switched to open-label XR-NTX, with monthly individual drug counseling, for a further year. Setting Thirteen clinical sites in Russia. Participants Adult opioid-dependent outpatients. Measurements Monthly urine samples; reports of craving and functioning; adverse events. Findings For the open-label extension (n = 114), 67 continued on XR-NTX and 47 switched from PBO during the double-blind phase to XR-NTX during the open-label phase. Overall, 62.3% (95% CI: 52.7%, 71.2%) completed the extension. Discontinuation occurred most commonly because of withdrawal of consent (18.4%) and loss to follow-up (11.4%); two patients discontinued as a result of lack of efficacy and one because of adverse events. Urine testing revealed that 50.9% (41.5%, 60.4%) were abstinent from opioids at all assessments during the 1-year open-label phase. Adverse events reported by 21.1% of patients were judged to be study drug-related. Injection site reactions were infrequent (6.1%) and the majority were mild. Elevations in liver function tests occurred for 16.7% of patients, but none of these elevations was judged to be clinically significant. No patients died, overdosed or discontinued as a result of severe adverse events. Conclusions During a 1-year open-label extension phase of injectable XR-NTX for the prevention of relapse in opioid dependence, 62.3% of patients completed the phase and 50.9% were abstinent from opioids. No new safety concerns were evident.
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