Alcohol MisusePhase 2NCT07132177
Targeted Naltrexone to Support Individuals Participating in Dry January
A Phase 2 study testing Naltrexone (oral tablets) in people with Alcohol Misuse, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Misuse
- What is being tested?
- Naltrexone (oral tablets)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2025to 1 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's hospital
Boston, Massachusetts, 02115
About this study
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
- Being tested
- Naltrexone (oral tablets)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naltrexone (oral tablets)Drug
All participants will receive 31 pills of 50 mg Naltrexone to take as needed over the month of January 2026.
| Study group | Role | What they receive |
|---|---|---|
| Naltrexone | Experimental | All participants will receive 31 pills of 50mg Naltrexone to take as needed over the month of January 2026 Receives: Drug: Naltrexone (oral tablets) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to 3 business days following baseline visit
Naltrexone adherence
The total number of naltrexone tablets taken will be assessed by pill count.
Measured: 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.
Measured: Up to 3 business days following baseline visit
Secondary outcomes (8)
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.
Measured: Up to 3 business days following baseline visit
Alcohol Withdrawal
Clinical Institute Withdrawal Assessment (CIWA)8: Tool for assessing alcohol withdrawal.
Measured: 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.
Measured: Up to 3 business days following baseline visit
Alcohol Craving
Penn Alcohol Craving Scale:13 A measure of craving for alcohol.
Measured: 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.
Measured: 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.
Measured: 1 month during the month of January 2026
Acceptability of Intervention
Acceptability of Intervention Measure (AIM): 4 item scale
Measured: Up to 3 business days following baseline visit
Safety Check
Liver Function Test: lab work/blood test
Measured: Up to 3 business days following baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start3 Nov 2025
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol MisuseStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joji Suzuki, MD, Brigham and Women's Hospital
- Investigators
- Joji Suzuki, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132177
- Sponsor's protocol ID
- 2025P000000
- Status last verified
- Apr 2026
- First submitted
- 30 Jul 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Naltrexone to Support Individuals Participating in Dry January
- ClinicalTrials.gov ID
- NCT07132177
- Acronym / sponsor ID
- 2025P000000
- Conditions
- Alcohol Misuse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Naltrexone | Experimental | Drug: Naltrexone (oral tablets)All participants will receive 31 pills of 50mg Naltrexone to take as needed over the month of January 2026 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naltrexone (oral tablets)All participants will receive 31 pills of 50 mg Naltrexone to take as needed over the month of January 2026. | Drug | Naltrexone |
Primary outcome
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.
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.
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.
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.
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.
8 secondary outcomes
Change in Overall Drinking
Time frame: Up to 3 business days following baseline visit
Alcohol Withdrawal
Time frame: Up to 3 business days following baseline visitn
Quality of Life Assessment
Time frame: Up to 3 business days following baseline visit
Alcohol Craving
Time frame: Up to 3 business days following baseline visit
Overall Alcohol Consumption
Time frame: Up to 3 business days following baseline visit
Medication Adherence
Time frame: 1 month during the month of January 2026
Acceptability of Intervention
Time frame: Up to 3 business days following baseline visit
Safety Check
Time frame: Up to 3 business days following baseline visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joji Suzuki, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Naltrexone (oral tablets) in people with Alcohol Misuse, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment feasibility (time frame: Up to 3 business days following baseline visit). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.