Targeted Naltrexone to Support Individuals Participating in Dry January

Phase 2RecruitingNCT07132177

Brigham and Women's Hospital20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Alcohol Misuse

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Recruitment feasibility

Recruitment: Proportion of those screened who successfully enroll in the trial. Greater than 75% enrollment will be considered excellent, and greater than 50% enrollment will be considered good.