MedDataX Logo

Targeted Naltrexone to Support Individuals Participating in Dry January

NCT ID: NCT07132177

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-03

Study Completion Date

2026-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alcohol Misuse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Naltrexone

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

Group Type EXPERIMENTAL

Naltrexone (oral tablets)

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Naltrexone (oral tablets)

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Joji Suzuki, MD

Director, Division of Addiction Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Joji Suzuki, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Brigham and Women's hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Joji Suzuki, MD

Role: CONTACT

Phone: 6177325752

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2025P000000

Identifier Type: -

Identifier Source: org_study_id