drugset / Trial / NCT07132177

Targeted Naltrexone to Support Individuals Participating in Dry January

NCT07132177

Phase 2 Completed 19 enrolled Brigham and Women's Hospital
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2025-11-03
Primary completion
2026-04-01
Completion
2026-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Naltrexone Small molecule 50 mg Oral

Indications