Targeted Naltrexone to Support Individuals Participating in Dry January

NCT07132177 | Completed Phase 2 FDA Drug

• 1 other identifier: 2025P000000
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Misuse

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (8)

• Change in Overall Drinking

  Up to 3 business days following baseline visit

• Alcohol Withdrawal

  Up to 3 business days following baseline visitn

• Quality of Life Assessment

  Up to 3 business days following baseline visit

• Alcohol Craving

  Up to 3 business days following baseline visit

• Overall Alcohol Consumption

  Up to 3 business days following baseline visit

Other Outcomes (1)

• Interview Outcomes

  At final study visit

Study Arms (1)

Naltrexone

EXPERIMENTAL

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

Drug: Naltrexone (oral tablets)

Interventions

Naltrexone (oral tablets) DRUG

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

Naltrexone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Interventions

Naltrexone

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Joji Suzuki, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Addiction Psychiatry

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 20, 2025
• Study Start: November 3, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)