Injectable extended-release naltrexone effective for opioid dependence

Référence

Tanum L, Solli KK, Latif Z, et al. Effectiveness of injectable extended-release naltrexone vs daily buprenorphine-naloxone for opioid dependence. A randomized clinical noninferiority trial. JAMA Psychiatry 2017;74(12):1197-1205.

Sommaire

The use of oral medications to treat opioid dependence is fraught with low adherence and a high dropout rate. These investigators identified 159 adults, aged 18 years to 60 years, who met standard diagnostic criteria for opioid dependence. Study participants randomly received (concealed allocation assignment) oral buprenorphine-naloxone 4 mg to 24 mg per day administered in a controlled environment or intramuscular ER naltrexone 380 mg every 4 weeks. Although individuals who assessed outcomes were not masked to treatment group assignments, individual primary outcomes were objective and minimally prone to biased reporting (eg, study retention rate, number of days with negative urine drug tests (UDTs), number of days of heroin and other illicit opioid use). Missing UDTs were 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 ER naltrexone group. (23 vs 15, respectively). Using intention-to-treat analysis, no significant differences occurred between the ER naltrexone group and the oral buprenorphine-naloxone group in study retention time, negative opioid UDTs, and days of use of heroin and other illicit opioids. Similarly, no group differences occurred in the use of amphetamines, cocaine, alcohol, cannabis, or injected drugs. Significantly more patients in the ER 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.