Targeted Naltrexone to Support Individuals Participating in Dry January (NCT07132177) | Clinical Trial Compass
CompletedPhase 2
Targeted Naltrexone to Support Individuals Participating in Dry January
United States19 participantsStarted 2025-11-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recruitment feasibility
Timeframe: Up to 3 business days following baseline visit
2
Retention feasibility
Timeframe: Up to 3 business days following baseline visit
3
Intervention acceptability
Timeframe: Up to 3 business days following baseline visit
4
Naltrexone adherence
Timeframe: 1 month during the month of Januaray 2026
5
Safety Measure
Timeframe: Up to 3 business days following baseline visit