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RECRUITING
NCT07132177
PHASE2

Targeted Naltrexone to Support Individuals Participating in Dry January

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-11-03

Completion Date

2026-05-01

Last Updated

2025-11-06

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Naltrexone (oral tablets)

All participants will receive 31 pills of 50 mg Naltrexone to take as needed over the month of January 2026.

Locations (1)

Brigham and Women's hospital

Boston, Massachusetts, United States