Targeted Naltrexone to Support Individuals Participating in Dry January
Purpose
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.
Condition
- Alcohol Misuse
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- English speaking adults aged 18 and above - Intending to participate in "Dry January" in January of 2026 by either completely stopping or moderating (reducing) their drinking - Available to travel to BWH CCI outpatient facilities for study visits
Exclusion Criteria
- DSM-5 diagnosis of moderate or severe AUD - Seeking treatment for AUD - Currently receiving medications for treating AUD (naltrexone, acamprosate, disulfiram) - CIWA score > 3 at the time of enrollment - Blood alcohol level (BAL) > 0 at enrollment - Current DSM-5 diagnosis of any other SUD except for tobacco use disorder - History of any inpatient alcohol withdrawal (i.e. "detox") admission - History of severe withdrawal syndrome including withdrawal seizure or delirium tremens - Active psychosis, mania, suicidality or homicidally or any psychiatric condition that impair ability to provide informed consent - Liver function test greater than 3 times upper normal limit or severe renal impairment - History of hypersensitivity or allergy to naltrexone - Currently or anticipating requiring opioid analgesics for pain during the trial - Pregnant or breastfeeding - Anticipated to permanently leave the Boston area during the duration of the trial. - Anticipated to be enrolled in another clinical drug trial during participation of this trial - Any other reason or clinical condition that the investigators judge may interfere with study participation and/or be unsafe for a participant
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Naltrexone |
All participants will receive 31 pills of 50mg Naltrexone to take as needed over the month of January 2026 |
|
Recruiting Locations
Boston 4930956, Massachusetts 6254926 02115
More Details
- Status
- Recruiting
- Sponsor
- Brigham and Women's Hospital