Targeted Naltrexone to Support Individuals Participating in Dry January

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 Overview

• Status: Completed
• Conditions: Alcohol Misuse
• Intervention / Treatment: Drug: Naltrexone (oral tablets)

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Naltrexone; All participants will receive 31 pills of 50mg Naltrexone to take as needed over the month of January 2026	Drug: Naltrexone (oral tablets); All participants will receive 31 pills of 50 mg Naltrexone to take as needed over the month of January 2026.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Principal Investigator: Joji Suzuki, MD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2025
• Primary Completion (Actual): April 1, 2026
• Study Completion (Actual): April 1, 2026

Study Registration Dates

• First Submitted: July 30, 2025
• First Submitted That Met QC Criteria: August 18, 2025
• First Posted (Actual): August 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Naloxone; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Naltrexone
• Other Study ID Numbers: 2025P000000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No