Feasibility and safety of extended-release naltrexone treatment of opioid and alcohol use disorder in HIV clinics: A pilot/feasibility randomized trial.
This is the primary outcomes article for CTN-0055.
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. This non-blinded, randomized trial, CTN-0055 (CHOICES), compared 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. The study was set in HIV primary care clinics in Vancouver, British Columbia, and Chicago, Illinois. Fifty-one HIV-infected patients seeking treatment for opioid use disorder (OUD, n=16), alcohol use disorder (AUD, n=27), or both (n=8) were randomized. 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.
Results found that two-thirds (68%) of participants assigned to XR-NTX initiated treatment, and 88% of these were retained on XR-NTX at 16 weeks. By 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 18-13 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. The findings underscore the need for a multi-site trial to test the potential of XR-NTX for improving engagement in the HIV care continuum. Use of long-acting addiction pharmacotherapies such as XR-NTX may improve the capacity for HIV-infected patients with substance use disorders to better engage in HIV treatment and close gaps in the HIV care continuum.
Related protocols: CTN-0055