An Open-Label Pilot Study of Pregabalin as Treatment for Alcohol Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Maximum Dose of Pregabalin:
研究概览
简要总结
The proposed protocol is an 8 week open label outpatient pilot trial of the safety and efficacy of pregabalin (Lyrica) in the treatment of alcohol use disorder. The primary objective of the study is to determine the efficacy of pregabalin in promoting alcohol abstinence among individuals with an alcohol use disorder.
详细描述
The proposed protocol is an open label outpatient pilot trial of the safety and efficacy of pregabalin (Lyrica) in the treatment of alcohol use disorder. Pregabalin is commonly used for the treatment of pain issues such as fibromyalgia (chronic pain in your body), diabetic nerve pain, spinal cord injury nerve, and pain after shingles. We plan to enroll 20 participants in an 8-week trial.The ideal dosing, tolerability, and safety of pregabalin will be tested in outpatients with Alcohol Use Disorder (AUD). The primary objective of the study is to determine the efficacy of pregabalin in promoting alcohol abstinence among individuals with an alcohol use disorder.
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 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 AUD, that in the investigator's judgment might require intervention over the course of the study.
- •Subjects receiving psychotropic medication treatment
- •Evidence of moderate-to-severe alcohol withdrawal (CIWA-Ar > 13)
- •History of alcohol withdrawal seizures or alcohol withdrawal delirium
- •History of allergic reaction to candidate medication (pregabalin)
- •Pregnancy, lactation, or failure in females 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 use disorders. A diagnosis of a mild substance use disorder will not be exclusionary, as long as the current primary substance use disorder is alcohol.
- •Are legally mandated to participate in alcohol use disorder treatment program
- •Cognitively impaired
研究组 & 干预措施
pregabalin
pregabalin up to daily dose of 600 mg
干预措施: Pregabalin (Drug)
结局指标
主要结局
Maximum Dose of Pregabalin:
时间窗: over the course of the 8 week trial or participants' length of participation
Defined as the highest amount of medication per day maintained for a 7 day period.
次要结局
未报告次要终点
研究者
John Mariani MD
Research psychiatrist
New York State Psychiatric Institute