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Opioid use disorder (OUD) is a major global public health problem, with overdose rates rising precipitously over the last two decades in the U.S. Conventionally, methadone and buprenorphine-naloxone are used to treat OUD; they also reduce opioid use, overdose, and criminal activity. However, as these treatments are themselves opioids, physical dependence continues, illicit use can occur, and access to treatment can be a major challenge. Naltrexone is an opioid antagonist without these problems, and when given in an extended-release form (ERN; i.e., monthly injections), it increases abstinence compared with placebo. Enthusiasm for its widespread use has been dampened by poor adherence rates. In a noninferiority trial of ERN compared with daily buprenorphine-naloxone, researchers recruited 159 participants with opioid dependence from outpatient or inpatient detoxification centers in Norway.
Buprenorphine-naloxone (mean dose, 11 mg/day; target dose, 16 mg/day) or ERN (380 mg intramuscularly every fourth week) was given for 12 weeks. By the final week, ERN showed somewhat higher, statistically noninferior retention (dropouts: ERN, 24; buprenorphine-naloxone, 29). Treatment outcomes (urine drug tests and self-reported use) with ERN were also noninferior. However, the ERN group had somewhat lower mean past-month opioid use days at baseline (but not years of use and rates of intravenous opioid use), which could have biased results.
Tanum L et al. The effectiveness of injectable extended-release naltrexone vs daily buprenorphine-naloxone for opioid dependence: A randomized clinical noninferiority trial. JAMA Psychiatry 2017 Oct 18; [e-pub]. (http://dx.doi.org/10.1001/jamapsychiatry.2017.3206)
Comment
Results from this Norwegian study, the first published prospective clinical trial comparing ERN to buprenorphine-naloxone, indicate that ERN should be considered an equally efficacious treatment. Non-opioid OUD treatments are especially attractive for high-risk individuals who previously have had issues with diversion or for whom overdose is of greater concern, as in patients who also misuse benzodiazepines. Larger studies in other populations are needed to confirm these promising findings.