A Randomized Controlled Clinical Trial of the Neuroimmune Modulator Ibudilast for the Treatment of Alcohol Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Percent Heavy Drinking Days
研究概览
简要总结
This study is a double-blind, placebo-controlled randomized clinical trial of Ibudilast (IBUD) (50mg twice a day) for the treatment of Alcohol Use Disorder (AUD). Eligible participants will undergo a 12-week medication treatment period and 5 in-person visits over 16 weeks.
详细描述
The study design consists of a 12-week, double-blind, placebo-controlled randomized clinical trial of IBUD (50mg twice a day) for the treatment of AUD. The investigators will randomize 132 treatment-seekers with current AUD over the course of 4 years. Participants will complete telephone screening, followed by in-person eligibility assessment, a physical exam for medical eligibility, randomization to study medication or matched placebo, and in-person follow-up visits at 4, 8, and 12 weeks of treatment. Timeline Followback (TLFB) assessment of drinking outcomes will also occur by telephone on weeks 2, 6, and 10. A final safety check visit will occur on week 16, consisting of repeated clinical labs and electrocardiography (ECG).
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be between the ages of 18 and 65
- •Meet current (i.e., past 12 months) Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for alcohol use disorder moderate or severe
- •Be treatment-seeking for alcohol use disorder (AUD)
- •Report drinking at least 28 drinks per week if male (21 drinks per week if female) in the 28 days prior to consent
排除标准
- •Have a current (last 12 months) DSM-5 diagnosis of substance use disorder for any psychoactive substances other than alcohol and nicotine
- •Have a lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder
- •Have a positive urine screen for narcotics, amphetamines, or sedative hypnotics;
- •Have clinically significant alcohol withdrawal symptoms as indicated by a score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-R)
- •Be pregnant, nursing, or planning to become pregnant while taking part in the study; and must agree to one of the following methods of birth control (if female), unless she or partner are surgically sterile:
- •Oral contraceptives
- •Contraceptive sponge
- •Double barrier
- •Intrauterine contraceptive device
- •Etonogestrel implant
- •Medroxyprogesterone acetate contraceptive injection
- •Complete abstinence from sexual intercourse
- •Hormonal vaginal contraceptive ring
- •Have a medical condition that may interfere with safe study participation (e.g., unstable cardiac, renal, or liver disease, uncontrolled hypertension or diabetes)
- •Have aspartate aminotransferase (AST), alanine transaminase (ALT), or gamma-glutamyl transferase (GGT) ≥ 3 times upper normal limit
- •Have attempted suicide in the past 3 years and/or have had serious suicidal intention or plan in the past year
- •Currently be on prescription medication that contraindicates use of ibudilast (IBUD), including alpha or beta agonists, theophylline, or other sympathomimetic
- •Currently be on any medications for AUD or any psychotropic medications (e.g., psychostimulants and benzodiazepines) with the exception of stable antidepressants (stable dose for ≥4 weeks)
- •Have any other circumstances that, in the opinion of the investigators, compromises participant safety.
研究组 & 干预措施
Ibudilast
10mg delayed-release capsules, target dose 50mg twice daily (5 x 10mg capsules twice daily) for 12 weeks
干预措施: Ibudilast (Drug)
Placebo Oral Capsule
matched to experimental drug
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Percent Heavy Drinking Days
时间窗: 12 week-treatment period
Heavy drinking days defined as 5+ drinks for men and 4+ for women. Reported outcome measures are proportions of heavy drinking days.
次要结局
- Drinks Per Day(12-week treatment period)
- Drinks Per Drinking Day(12-week treatment period)
- Percent Days Abstinent(12-week treatment period)
研究者
Lara Ray, PhD
Professor
University of California, Los Angeles