Targeted Naltrexone to Support Individuals Participating in Dry January
Completed · Phase 2
Conditions studied: Alcohol Misuse
In brief
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 facts
- Study ID
- NCT07132177
- Run by
- Brigham and Women's Hospital
- People needed
- 19
- Starts
- 2025-11-03
- Expected to finish
- 2026-04-01
- Last updated by the study team
- 2026-04-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Brigham and Women's hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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