Alcohol Misuse
Conditions
Brief 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.
Interventions
All participants will receive 31 pills of 50 mg Naltrexone to take as needed over the month of January 2026.
Sponsors
Brigham and Women's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Measure | Up to 3 business days following baseline visit | The incidence and severity of adverse events (AEs) will be documented using the Patient Rated Inventory of Side Effects (PRISE)6: A self-report tool to qualify side effects. For each domain, the patient rates whether the symptoms are tolerable or distressing. |
| Recruitment feasibility | Up to 3 business days following baseline visit | 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. |
| Retention feasibility | Up to 3 business days following baseline visit | Proportion of those enrolling who successfully complete all study visits. Greater than 80% retention will be considered excellent, and greater than 70% retention will be considered good. |
| Intervention acceptability | Up to 3 business days following baseline visit | The 4-item Acceptability of Intervention Measure (AIM) will be used, measured on a 5-point scale. |
| Naltrexone adherence | 1 month during the month of Januaray 2026 | The total number of naltrexone tablets taken will be assessed by pill count. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence | 1 month during the month of January 2026 | Morisky Medication Adherence Scale-MMAS: a 4 item self-report tool designed to assess how well patients stick to their prescribed medication regimens. |
| Acceptability of Intervention | Up to 3 business days following baseline visit | Acceptability of Intervention Measure (AIM): 4 item scale |
| Change in Overall Drinking | Up to 3 business days following baseline visit | Drinks per drinking days (DDD) will be calculated using the Time-Line Follow Back (TLFB)7, a gold-standard method of evaluating substance use. The TLFB results will also calculate proportion of heavy drinking days and proportion of days abstinent during the 4-week intervention. |
| Safety Check | Up to 3 business days following baseline visit | Liver Function Test: lab work/blood test |
| Alcohol Withdrawal | Up to 3 business days following baseline visitn | Clinical Institute Withdrawal Assessment (CIWA)8: Tool for assessing alcohol withdrawal. |
| Quality of Life Assessment | Up to 3 business days following baseline visit | WHO Quality of Life (WHOQOL-BREF)71: A 26-item quality of life scale. |
| Alcohol Craving | Up to 3 business days following baseline visit | Penn Alcohol Craving Scale:13 A measure of craving for alcohol. |
| Overall Alcohol Consumption | Up to 3 business days following baseline visit | PEth: An alcohol biomarker to assess overall alcohol consumption of the prior 2-4 weeks. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Interview Outcomes | At final study visit | A qualitative interview at follow-up will explore participants' experiences using naltrexone during Dry January. |
Countries
United States
Contacts
Primary ContactJoji Suzuki, MD
Outcome results
None listed