Clinical Question

Is injectable extended-release naltrexone (Vivitrol) as effective as daily oral buprenorphine/naloxone (Suboxone) for preventing relapse in adults with opioid use disorder?

Bottom Line

Injectable extended-release naltrexone administered every four weeks is similar in efficacy to daily oral buprenorphine/naloxone for the treatment of opioid use disorder. Patients using extended-release naltrexone reported higher satisfaction with treatment and were more likely to recommend it to others. (Level of Evidence = 1b–)

Synopsis

The use of oral medications to treat opioid use disorder is fraught with low adherence and a high dropout rate. These investigators identified 159 adults, 18 to 60 years of age, who met standard diagnostic criteria for opioid use disorder. Study participants randomly received (concealed allocation assignment) ora l buprenorphine/naloxone, 4 to 24 mg per day administered in a controlled environment, or intramuscular extended-release naltrexone, 380 mg every four weeks. Although individuals who assessed outcomes were not masked to treatment group assignments, individual primary outcomes were objective and minimally prone to biased reporting (e.g., study retention rate, number of days with negative urine drug tests, number of days of heroin and other illicit opioid use). Missing urine drug tests was considered positive for opioids. Complete follow-up occurred for 66% of participants at 12 weeks. More individuals in the daily buprenorphine/naloxone group failed to complete follow-up than in the extended-release naltrexone group (23 vs. 15, respectively).

Using intention-to-treat analysis, no significant differences occurred between the extended-release naltrexone group and the oral buprenorphine/naloxone group in study retention time, negative opioid urine drug tests, and days of heroin and other illicit opioid use. Similarly, no group differences occurred in the use of amphetamines, cocaine, alcohol, cannabis, or injected drugs. Significantly more patients in the extended-release naltrexone group had a reduction in days of benzodiazepine use and higher reported satisfaction, and significantly more were likely to recommend their treatment to others. No significant differences occurred in dropout rates due to adverse events.

Study design: Randomized controlled trial (single-blinded)

Funding source: Foundation

Allocation: Concealed

Setting: Outpatient (specialty)

Reference:TanumLSolliKKLatifZEet alEffectiveness of injectable extended-release naltrexone vs daily buprenorphine-naloxone for opioid dependence: A randomized clinical noninferiority trial. JAMA Psychiatry2017;74(12):1197–1205.