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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naltrexone | Experimental | All participants will receive 31 pills of 50mg Naltrexone to take as needed over the month of January 2026 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naltrexone (oral tablets) | Drug | All participants will receive 31 pills of 50 mg Naltrexone to take as needed over the month of January 2026. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 3 business days following baseline visit |
| Retention feasibility | 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. | Up to 3 business days following baseline visit |
| Intervention acceptability | The 4-item Acceptability of Intervention Measure (AIM) will be used, measured on a 5-point scale. | Up to 3 business days following baseline visit |
| Naltrexone adherence | The total number of naltrexone tablets taken will be assessed by pill count. | 1 month during the month of Januaray 2026 |
| Safety Measure | 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. | Up to 3 business days following baseline visit |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Overall Drinking | 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. | Up to 3 business days following baseline visit |
| Measure | Description | Time Frame |
|---|---|---|
| Interview Outcomes | A qualitative interview at follow-up will explore participants' experiences using naltrexone during Dry January. | At final study visit |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joji Suzuki, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's hospital | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D009271 | Naltrexone |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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| Alcohol Withdrawal | Clinical Institute Withdrawal Assessment (CIWA)8: Tool for assessing alcohol withdrawal. | Up to 3 business days following baseline visitn |
| Quality of Life Assessment | WHO Quality of Life (WHOQOL-BREF)71: A 26-item quality of life scale. | Up to 3 business days following baseline visit |
| Alcohol Craving | Penn Alcohol Craving Scale:13 A measure of craving for alcohol. | Up to 3 business days following baseline visit |
| Overall Alcohol Consumption | PEth: An alcohol biomarker to assess overall alcohol consumption of the prior 2-4 weeks. | Up to 3 business days following baseline visit |
| Medication Adherence | Morisky Medication Adherence Scale-MMAS: a 4 item self-report tool designed to assess how well patients stick to their prescribed medication regimens. | 1 month during the month of January 2026 |
| Acceptability of Intervention | Acceptability of Intervention Measure (AIM): 4 item scale | Up to 3 business days following baseline visit |
| Safety Check | Liver Function Test: lab work/blood test | Up to 3 business days following baseline visit |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |