Targeted Naltrexone to Support Individuals Participating in Dry January
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Recruitment feasibility
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Naltrexone
All participants will receive 31 pills of 50mg Naltrexone to take as needed over the month of January 2026
干预措施: Naltrexone (oral tablets) (Drug)
结局指标
主要结局
Recruitment feasibility
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 1 month during the month of Januaray 2026
The total number of naltrexone tablets taken will be assessed by pill count.
Safety Measure
时间窗: 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.
次要结局
- Change in Overall Drinking(Up to 3 business days following baseline visit)
- Alcohol Withdrawal(Up to 3 business days following baseline visitn)
- Quality of Life Assessment(Up to 3 business days following baseline visit)
- Alcohol Craving(Up to 3 business days following baseline visit)
- Overall Alcohol Consumption(Up to 3 business days following baseline visit)
- Medication Adherence(1 month during the month of January 2026)
- Acceptability of Intervention(Up to 3 business days following baseline visit)
- Safety Check(Up to 3 business days following baseline visit)
研究者
Joji Suzuki, MD
Director, Division of Addiction Psychiatry
Brigham and Women's Hospital