Targeted Naltrexone to Support Individuals Participating in Dry January

April 28, 2026 updated by: Joji Suzuki, MD, Brigham and Women's Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment feasibility
Time Frame: 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.
Up to 3 business days following baseline visit
Retention feasibility
Time Frame: 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.
Up to 3 business days following baseline visit
Intervention acceptability
Time Frame: 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.
Up to 3 business days following baseline visit
Naltrexone adherence
Time Frame: 1 month during the month of Januaray 2026
The total number of naltrexone tablets taken will be assessed by pill count.
1 month during the month of Januaray 2026
Safety Measure
Time Frame: 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.
Up to 3 business days following baseline visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Overall Drinking
Time Frame: 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.
Up to 3 business days following baseline visit
Alcohol Withdrawal
Time Frame: Up to 3 business days following baseline visitn
Clinical Institute Withdrawal Assessment (CIWA)8: Tool for assessing alcohol withdrawal.
Up to 3 business days following baseline visitn
Quality of Life Assessment
Time Frame: Up to 3 business days following baseline visit
WHO Quality of Life (WHOQOL-BREF)71: A 26-item quality of life scale.
Up to 3 business days following baseline visit
Alcohol Craving
Time Frame: Up to 3 business days following baseline visit
Penn Alcohol Craving Scale:13 A measure of craving for alcohol.
Up to 3 business days following baseline visit
Overall Alcohol Consumption
Time Frame: Up to 3 business days following baseline visit
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
Time Frame: 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.
1 month during the month of January 2026
Acceptability of Intervention
Time Frame: Up to 3 business days following baseline visit
Acceptability of Intervention Measure (AIM): 4 item scale
Up to 3 business days following baseline visit
Safety Check
Time Frame: Up to 3 business days following baseline visit
Liver Function Test: lab work/blood test
Up to 3 business days following baseline visit

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Interview Outcomes
Time Frame: At final study visit
A qualitative interview at follow-up will explore participants' experiences using naltrexone during Dry January.
At final study visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brigham and Women's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joji Suzuki, MD, Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 3, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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