Research on Translational Outcomes of Alcohol (Project RETRO)
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Alcohol Consumption
研究概览
简要总结
The primary aim of the current study is to assess the effect of a single dose of carbidopa-levodopa on ad libitum alcohol consumption and alcohol craving in young adults with a history of binge drinking.
详细描述
This is a small (N = 42) 2-arm, double-blind, randomized controlled pilot study to assess the effect of a single dose of immediate release carbidopa-levodopa (50mg/500mg) to acutely reduce alcohol consumption and craving in college students with a history of heavy episodic drinking. Participants will be between 21-24 years old from 2- and 4- year colleges in the Seattle Metropolitan area. Interested students will contact the study line and provide verbal consent to be sent a link to an online screening survey. Eligible participants will be scheduled to come in for the ad libitum alcohol administration. Participants will receive either the carbidopa-levodopa or a placebo and complete the alcohol administration protocol.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 24 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Enrolled in 2- or 4-year college program
- •Currently living in the Seattle Metropolitan area
- •Have at least two or more episodes of heavy episodic drinking (4/5 or more drinks in a 2 hours for women/men) in the past 30 days.
排除标准
- •Exclusion criteria include:
- •past-month severe alcohol or other substance use disorders,
- •mood or anxiety disorder
- •suicidal ideation
- •risk of psychotic disorders
- •excessive alcohol use reaching a Blood Alcohol Level greater than .30%
- •history of serious medical conditions, regular use of prescription psychotropic or pain medication
- •history of negative reactions to alcohol
- •history of treatment for alcohol use disorder
- •pregnancy or nursing.
- •use of non-selective monoamine oxidase inhibitors in the past 2 weeks.
- •narrow-angle glaucoma
- •undiagnosed skin lesions,
- •have a history of melanoma, cardiac issues or peptic ulcer.
- •Currently taking or prescribed any form of levodopa or D2 agonists, D2 antagonists, isoniazid, methylphenidate, bupropion, Viagra, or phosphodiesterase inhibitors.
研究组 & 干预措施
Control, Placebo
Similar looking tablet(s) to active drug will be administered in a single dose to those who are randomly assigned to this group.
干预措施: Placebo (Drug)
Active Drug, Carbidopa + Levodopa
Single dose of immediate release carbidopa-levodopa (50mg/500mg).
干预措施: Carbidopa Levodopa (Drug)
结局指标
主要结局
Alcohol Consumption
时间窗: 1 hour
Number of alcoholic drinks consumed
Alcohol Craving
时间窗: 30 minutes in to alcohol administration
Amount of alcohol craving as assessed by the Alcohol Urge Questionnaire by Bohn, Krahn \& Staehler (1995)
次要结局
- Alcohol craving(At the end of alcohol administration. Alcohol administration is 1 hour.)
研究者
Brittney Hultgren
Acting Assistant Professor Department of Psychiatry and Behavioral Sciences
University of Washington