Targeted Naltrexone to Support Individuals Participating in Dry January
Brigham and Women's Hospital
20 participants
Nov 3, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria16
- 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
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Interventions
All participants will receive 31 pills of 50 mg Naltrexone to take as needed over the month of January 2026.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07132177