Targeted Naltrexone to Support Individuals Participating in Dry January

Mass General Brigham

Status and phase: Enrolling; Phase 2

Conditions: Alcohol Misuse

Treatments: Drug: Naltrexone (oral tablets)

Study type: Interventional

Funder types: Other

Identifiers

NCT07132177

2025P000000

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Naltrexone

Experimental group

Description:

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

Treatment:

Drug: Naltrexone (oral tablets)