Phase 2 Study of Apremilast in Women and Men With Alcohol Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Alcohol Consumption
研究概览
简要总结
For this protocol, the investigators plan to collect data to evaluate apremilast (60mg/day) vs placebo in adults with Alcohol Use Disorders (AUD).
详细描述
This human laboratory study is a Phase 2 double-blind, placebo-controlled, parallel group design which will compare apremilast (60mg/day) to placebo in non-treatment seeking adults meeting criteria for DSM 5 alcohol use disorders (n=80, 40 per cell, 50% females).
Eligibility screening consists of an intake session and a physical exam. Subjects meeting eligibility criteria will be assigned to apremilast (60mg/day) or placebo. Titration to steady state medication levels occur over 6 days (Day 1-6). Subjects will then complete three laboratory sessions (Days 7-24). During each laboratory session, personalized imagery (within-subject factor, either stress or stimulation or neutral, order counterbalanced) will precede a 2-hour alcohol self-administration period. Participants will remain on study medication for a 28-day period, during which naturalistic drinking will be evaluated.
No taper medication is needed. Following the discontinuation of medication (Day 30), participants will be assessed for an additional 1-month period.
Adverse events are evaluated at each study appointment and will be tabulated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to read and write English.
- •Meets DSM-5 criteria for current (past 6 months) AUD.
- •Drinking criteria: males - drinks > 14 drinks per week and exceeds 4 drinks per day at least twice per week; females - drinks > 7 drinks per week and exceeds 3 drinks per day at least twice per week. They must meet drinking criteria during a consecutive 30-day period prior to baseline.
- •Laboratory sessions will be scheduled such that subjects will not have major responsibilities on the following day which might limit drinking during the self-administration session (e.g., job interview, exam).
- •Able to take oral medications and willing to adhere to medication regimen.
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
排除标准
- •Subjects with any significant current medical conditions (neurological, cardiovascular, endocrine, thyroid, renal, liver), seizures, delirium or hallucinations, or other unstable medical conditions, including HIV.
- •Current DSM-5 substance use disorder (other than AUD or tobacco use disorder).
- •A positive test result at intake appointment on urine drug screens conducted for illicit drugs.
- •Past 30-day use of psychoactive drugs may be included at the discretion of the study MD as long as the concurrent treatment does not compromise the study integrity by virtue of its type, duration, or intensity.
- •Women who are pregnant or nursing, or fail to use one of the following methods of birth control unless she or her partner is surgically sterile or she is postmenopausal (hormone contraceptives [oral, implant, injection, patch, or ring], contraceptive sponge, double barrier [diaphragm or condom plus spermicide], or IUD).
- •Suicidal, homicidal, or evidence of current (past 6 months) mental illness such as schizophrenia, bipolar disorder or major depression, or anxiety disorders.
- •Only one member per household can participate in the study.
- •Specific exclusions for administration of apremilast not already specified include: known hypersensitivity to apremilast; cytochrome P450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin).
- •Drugs that may influence study outcomes (e.g., disulfiram, naltrexone, acamprosate, anticonvulsants).
- •Subjects likely to exhibit clinically significant alcohol withdrawal during the study. We will exclude subjects who a) have a history of perceptual distortions, seizures, delirium, or hallucinations upon withdrawal, or b) have a score of > 8 on the Clinical Institute Withdrawal Assessment scale at intake appointments.
- •Subjects who have taken any investigational drug within 4 weeks immediately preceding admission to the study period.
- •Participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current application.
- •Individuals who are currently in treatment for drinking or who have attempted to quit drinking within the past 3 months in order to exclude participants seeking treatment.
- •Individuals with a history of serious withdrawal, and individuals who have repeatedly undergone alcohol detoxification.
研究组 & 干预措施
Apremilast 60mg/day
Apremilast 60mg/day. Administered orally twice daily at 8:00 AM and 8:00 PM while titrating to the full dose. Titration schedule: Day 1 10mg AM; Day 2 10mg AM, 10mg PM; Day 3 10mg AM, 20mg PM; Day 4 20mg AM, 20mg PM; Day 5 20 mg AM, 30mg PM; Day 6 30mg AM, 30mg PM. Once at steady state, administration is orally twice daily at 8:00 AM (30mg) and 8:00 PM (30mg).
干预措施: Apremilast 60mg (Drug)
Apremilast 90mg/day
Apremilast 90mg/day. Administered orally twice daily at 8:00 AM and 8:00 PM while titrating to the full dose. Titration schedule: Day 1 10mg AM; Day 2 10mg AM, 10mg PM; Day 3 10mg AM, 20mg PM; Day 4 20mg AM, 20mg PM; Day 5 20 mg AM, 30mg PM; Day 6 30mg AM, 30mg PM; Day 7 40mg AM, 30mg PM; Day 8 50mg AM, 30mg PM; Day 9 60mg AM, 30mg PM. Once at steady state, administration is orally twice daily at 8:00 AM (60mg) and 8:00 PM (30mg).
干预措施: Apremilast 90mg (Drug)
Placebo
Administered orally twice daily at 8:00 AM and 8:00 PM.
干预措施: Placebo (Other)
结局指标
主要结局
Alcohol Consumption
时间窗: Lab Sessions (Days 10, 17 & 24)
For the ad-libitum drinking sessions (120 mins), the primary outcome variable will be calculated as percent milliliters consumed = number of milliliters consumed/total amount available.
次要结局
未报告次要终点