Feasibility and safety of extended-release naltrexone treatment of opioid and alcohol use disorder in HIV clinics: A pilot/feasibility randomized trial

Background and aims HIV-infected persons with substance use disorders are least likely to benefit from advances in HIV treatment. Integration of extended-release naltrexone (XR-NTX) into HIV clinics may increase engagement in the HIV care continuum by decreasing substance use. We aimed to compare 1) XR-NTX treatment initiation, 2) retention, and 3) safety of XR-NTX versus treatment as usual (TAU) for treating opioid use disorder (OUD) and/or alcohol use disorder (AUD) in HIV clinics. Design Non-blinded randomized trial of XR-NTX versus pharmacotherapy TAU Setting HIV primary care clinics in Vancouver, BC, Canada and Chicago, IL, USA. Participants 51 HIV-infected patients seeking treatment for OUD (n = 16), AUD (n = 27) or both OUD and AUD (n = 8). Measurements Primary outcomes were XR-NTX initiation (receipt of first injection within 4 weeks of randomization) and retention at 16 weeks. Secondary outcomes generated point estimates for change in substance use, HIV viral suppression (HIV RNA pcr < 200 copies/mL), and safety. Findings Two-thirds (68%) of participants assigned to XR-NTX initiated treatment, and 88% of these were retained on XR-NTX at 16 weeks. In comparison, 96% of TAU participants initiated treatment, but only 50% were retained on medication at 16 weeks. Mean days of opioid use in past 30 days decreased from 19 to 10 for TAU (n = 12) and from 18 to 13 for XR-NTX (n = 10). Mean heavy drinking days decreased from 18 to 7 for TAU (n = 11) and 13 to 6 for XR-NTX (n = 12). Among those with OUD, HIV suppression improved from 67% to 80% for XR-NTX and 58% to 75% for TAU. XR-NTX was well-tolerated, with no precipitated withdrawals and 1 serious injection site reaction. Conclusions Extended-release naltrexone (XR-NTX) is feasible and safe for treatment of opioid use disorder and alcohol use disorder in HIV clinics. Treatment initiation appears to be lower and retention greater for XR-NTX compared with treatment as usual. (clinicaltrials.gov NCT01908062).