NCT07325266招募中2 期
Human Laboratory Study of Apremilast for Alcohol Use Disorder
National Institute on Alcohol Abuse and Alcoholism (NIAAA)3 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年4月3日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Alcohol Craving
研究概览
简要总结
Primary: The primary objective of this study is to compare the efficacy of two different maintenance doses of apremilast (tablets) in reducing alcohol craving among subjects with moderate to severe alcohol use disorder (AUD) after two weeks of daily dosing.
Secondary: Secondary objectives include evaluation of two different maintenance doses of apremilast compared with matched placebo on other measures of self-reported alcohol consumption, alcohol craving, alcohol-related negative consequences, AUD symptoms, pain, sleep disturbances, depression, anxiety, quality of life, cigarette smoking, other nicotine use, cannabis use, retention in the study, and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(not exhaustive list):
- •Be at least 21 years of age.
- •Have a current (past 12 months) DSM-5 diagnosis of AUD (4 or more symptoms) assessed using the MINI neuropsychiatric interview version 7.0.2 (at least moderate severity).
- •Have a BAC by breathalyzer equal to 0.000 when s/he signed the informed consent document (either just prior to or immediately after signing consent).
- •Be seeking treatment for problems with alcohol and express a goal of abstinence or a reduction in drinking.
- •Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol.
- •Agree (if the participant is female and of childbearing potential) to use at least one of the following methods of birth control, unless she is surgically sterile, partner is surgically sterile or she is postmenopausal:
- •oral contraceptives,
- •contraceptive sponge,
- •double barrier (diaphragm/spermicidal or condom/spermicidal),
- •intrauterine contraceptive system,
- •etonogestrel implant,
- •medroxyprogesterone acetate contraceptive injection,
- •complete abstinence from sexual intercourse, and/or
- •hormonal vaginal contraceptive ring.
- •Be willing to adhere to the investigational product dosing schedule.
- •Complete all assessments required at screening and baseline.
- •Have a place to live in the 2 weeks prior to randomization and not be at risk that s/he will lose his/her housing by Study Week
- •Not anticipate any significant problems with transportation arrangements or available time to travel to the study site by Study Week
- •Not have any plans to move within Study Week 6 to a location which would make continued participation in the study impractical.
- •Provide contact information of someone, such as a family member, spouse, or significant other, who may be able to contact the participant in case of a missed clinic appointment.
- •Be someone who in the opinion of the investigator would be expected to complete the study protocol.
- •Agree to the schedule of visits, verbally acknowledge that s/he will be able to attend each scheduled visit, participate in phone visits and that s/he does not have any already scheduled events or a job that may substantially interfere with study participation.
- •If taking a medication for depression, must have been taking a stable dose in the 2-months prior to randomization and plan to continue during the study. This includes drugs such as the following:
- •Dual uptake inhibitors
- •Tricyclic antidepressants
- •Bupropion
- •Not currently taking apremilast and agree not to take non-study supplied apremilast for the duration of the study.
- •Have normal renal function defined as creatinine clearance ≥ 60 mL per minute by the Cockcroft-Gault equation.
排除标准
- •Contact study site for exclusion criteria
研究组 & 干预措施
Oral Apremilast 60 mg/day
Active Comparator
Apremilast, 30mg per capsule, administered twice daily (AM/PM), Placebo, administered once daily (AM)
干预措施: Apremilast (Drug)
Oral Apremilast 90 mg/day
Active Comparator
Apremilast, 30mg per capsule, 2 capsules (AM) and 1 capsule (PM)
干预措施: Apremilast (Drug)
Oral Matched Placebo
Placebo Comparator
Placebo, capsule, 2 capsules (AM) and 1 capsule (PM)
干预措施: Placebo (Drug)
结局指标
主要结局
Alcohol Craving
时间窗: Week 4
The primary outcome measure of this study is to compare the efficacy of two different maintenance doses of apremilast (tablets) in reducing alcohol craving among participants with moderate to severe alcohol use disorder (AUD) after two weeks of daily dosing.
次要结局
- Heavy drinking days per week(Weeks 2-5)
- Participants abstinent from cigarette smoking(Weeks 4-5)
- Number of drinks per drinking day(Weeks 2-5)
- Number of days of cannabis use per week(Weeks 4-6)
- Participants with no heavy drinking days(Weeks 2-5)
- Participants abstinent from alcohol(Weeks 2-5)
- Days abstinent from alcohol per week.(Weeks 2-5)
- Participants with at least a WHO 2-level decrease in alcohol consumption(Weeks 2-5)
- Number of drinks per week(Weeks 2-5)
- Alcohol Use Disorder Symptoms(Week 6)
- Sleep Disturbance(Weeks 4,6)
- PROMIS pain intensity score(Weeks 4,6)
- Global Health Score(Weeks 4,6)
- Alcohol Negative Consequences Score(Weeks 4,6)
- PROMIS-Anxiety Scale score(Weeks 4-6)
- Inflammatory Markers(Weeks 3, 6)
- HAM-D17 score(Weeks 2,4,6)
- Urge to Drink scale scores(Weeks 2-5)
研究者
研究点 (3)
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