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Completed

NCT Number: NCT07132177

Targeted Naltrexone to Support Individuals Participating in Dry January

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.

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Key information

Conditions

Alcohol Misuse

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Brigham and Women's hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naltrexone (oral tablets)

Drug

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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.

  2. Alcohol Withdrawal

    Time frame: Up to 3 business days following baseline visitn

    Clinical Institute Withdrawal Assessment (CIWA)8: Tool for assessing alcohol withdrawal.

  3. 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.

  4. Alcohol Craving

    Time frame: Up to 3 business days following baseline visit

    Penn Alcohol Craving Scale:13 A measure of craving for alcohol.

  5. 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.

  6. 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.

  7. Acceptability of Intervention

    Time frame: Up to 3 business days following baseline visit

    Acceptability of Intervention Measure (AIM): 4 item scale

  8. Safety Check

    Time frame: Up to 3 business days following baseline visit

    Liver Function Test: lab work/blood test

Other outcomes

  1. Interview Outcomes

    Time frame: At final study visit

    A qualitative interview at follow-up will explore participants' experiences using naltrexone during Dry January.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 20, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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