This study is a pragmatic, randomized, open-label clinical trial of 24 weeks of extended-release naltrexone (XR-NTX) versus oral naltrexone (O-NTX) using a COMBINE-adapted medical management primary care treatment model. We recruited 237 adults 18 years of age or older with alcohol dependence from the community into treatment at a major New York City primary care site—the adult primary care clinic at NYC Health + Hospitals/Bellevue. The primary outcome is a dichotomous good clinical outcome defined by abstinence or moderate drinking, as measured by the Timeline Followback Method and analyzed using an intention-to-treat approach among all randomized participants.

This study concluded recruitment in August 2017 and completed the final study visit in October 2018. Overall, participants reported improved longitudinal drinking outcomes and treatment retention remain high throughout the study. There was insufficient evidence of any differences in primary and secondary self-reported drinking outcomes between monthly XR-NTX and daily O-NTX. Cost and value comparisons will be taken from Week 5-24 data.

This study is supported by the National Institute on Alcohol Abuse and Alcoholism (NCT01893827).