Targeted Naltrexone to Support Individuals Participating in Dry January

This pilot open-label study will assess the feasibility, acceptability, and preliminary efficacy of targeted (as-needed) oral naltrexone in individuals participating in "Dry January," a month-long voluntary abstinence or reduction in alcohol use. Participants who do not meet criteria for alcohol use disorder (AUD) but are interested in reducing or abstaining from alcohol will receive a 31-day supply of 50mg oral naltrexone to take either prior to anticipated drinking or daily as a precaution. The study will evaluate recruitment, retention, adherence, and safety, as well as changes in alcohol use patterns, craving, mood, liver function, and quality of life. A qualitative interview at follow-up will explore participants' experiences using naltrexone during Dry January. Results will inform future randomized trials testing low-intensity, scalable interventions for non-treatment-seeking individuals seeking to reduce alcohol consumption.

NCT Number	NCT07132177
Lead Sponsor	Brigham and Women's Hospital
Conditions	Alcohol Misuse
Enrollment	19 participants
Start Date	2025-11-03
Primary Completion	2026-04-01 (estimated)
Study Completion	2026-04-01 (estimated)
Updated on ClinicalTrials.gov	2026-04-29