A Double-blind, Placebo-Controlled Trial of Pregabalin for the Treatment of Alcohol Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in proportion of heavy drinking days
研究概览
简要总结
In a 10-week randomized double-blind placebo-controlled outpatient pilot trial the efficacy of pregabalin in the treatment of alcohol dependence will be studied in 50 treatment-seeking outpatients. Participants will report drinking a minimum of 5 standard drinks for men or 4 standard drinks for women at least 4 days per week over the past 28 days.
详细描述
In a 10-week double-blind placebo controlled outpatient clinical trial, the safety and efficacy ofpregabalin will be tested in 50 outpatients with Alcohol Use Disorder.Participants will be randomly allocated (1:1) to receive pregabalin or an identical-appearing, inert placebo. All study medication (placebo and pregabalin) will be over-capsulated with riboflavin to assess compliance. Pregabalin will be administered in 75 mg and 100 capsules; placebo capsules will appear identical to the pregabalin capsules. Participants in both study arms will receive the same number of capsules. Pregabalin will be titrated over a 3-week period to the FDA maximum (600 mg per day) or the maximum tolerated dose.
Study visits will occur daily for the first 4 days of the study period, then approximately every other day for the remainder of week 1, for a total of 5 study visits (study days 1,2,3,4, and 5 or 7). During the second week, study visits will continue every other day for a total of 3 study visits (study days 8,10, and 12). During the remainder of the 8-week medication study period, study visits will occur twice weekly. There will be two visits during a post-study taper week (week 9) and a follow-up visit during week 10. One visit per week will be with the research psychiatrist. All participants will have a weekly supportive behavioral treatment session with the research psychiatrist using a manual designed for pharmacotherapy trials in subjects with alcohol use disorders
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, Investigator, Outcomes Assessor)
盲法说明
Pregabalin will be administered in 75 mg and 100 capsules; placebo capsules will appear identical to the pregabalin capsules. Participants in both study arms will receive the same number of capsules.
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
- •Meets DSM-5 criteria for current alcohol use disorder
- •Reports drinking a minimum of 5 standard drinks for men or 4 standard drinks for women at least 4 days per week over the past 28 days
- •Between the ages of 18 and 65
- •Able to provide informed consent and comply with study procedures
排除标准
- •Subjects with any current psychiatric disorder as defined by DSM-5, other than Alcohol use disorder, that in the investigator's judgment likely requiring ongoing dosage adjustments of their current medications or requiring changes in their medication and/or might require intervention over the course of the study, including schizophrenia, schizoaffective disorder, psychotic disorders other than transient psychosis due to drug abuse, bipolar disorder, and current suicidality with plan and intent. Individuals who are currently stable on a psychotropic medication for at least 3 months may be included if in the investigator's opinion the psychotropic medication is compatible with the study medication (pregabalin). The medications being allowed are commonly used antidepressants, including the SSRIs (e.g., fluoxetine, paroxetine, fluvoxamine, sertraline, citalopram, escitalopram), SNRI's (e.g., venlafaxine, desvenlafaxine, duloxetine), and bupropion.
- •Evidence of moderate-to-severe alcohol withdrawal Clinical Institute Withdrawal Assessment (revised version) (CIWA-Ar score ≥10)
- •History of alcohol withdrawal seizures or alcohol withdrawal delirium
- •History of allergic reaction to candidate medication (pregabalin)
- •Pregnancy, lactation, or failure in female patients to use adequate contraceptive methods
- •Unstable physical disorders which might make participation hazardous
- •Subjects who have a current DSM-5 diagnosis of moderate or severe substance use disorder, with the exception of alcohol, nicotine and caffeine dependence. A diagnosis of a mild substance use disorder will not be exclusionary, as long as the current primary substance use disorder is alcohol dependence.
- •Are legally mandated to participate in alcohol use disorder treatment program
研究组 & 干预措施
Pregabalin
Treatment with pregabalin administered in 75 mg and 100 capsules in dosages up to 600 mg per day for up to 8 weeks (including a 3 week titration run up) followed by a one week taper.
干预措施: Pregabalin (Drug)
Placebo
Individuals will receive the placebo capsules that appear identical to the pregabalin capsules and will receive the same number of capsules.
干预措施: Placebo (Other)
结局指标
主要结局
Change in proportion of heavy drinking days
时间窗: measured weekly over the 8 weeks of the medication phase of the trial or length of each individual's participation
Change in heavy drinking days as quantified by the proportion of heavy drinking days (defined as any day where the number of standard drinks was at least 5 for men and at least 4 for women) per week as measured by the timeline follow-back (TLFB) method.
次要结局
未报告次要终点
研究者
John Mariani MD
Research Psychiatrist
New York State Psychiatric Institute