A Double-Blind, Placebo-Controlled, Randomized Human Laboratory Pilot Study of Baclofen in Anxious Alcoholics
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Total Amount of Alcohol Consumed During the Alcohol Self Administration (ASA) Session
研究概览
简要总结
Background:
- Baclofen is a drug used to control muscle stiffness in people with neurological diseases. Some studies suggest that baclofen may reduce alcohol craving and use. It helps to reduce anxiety in alcoholics, which in turn can help to reduce cravings. Researchers want to see if baclofen can be a safe and effective treatment for alcoholics who have high anxiety levels.
Objectives:
- To see if baclofen is safe and helpful for people who have alcoholism and high anxiety levels.
Eligibility:
- Individuals between 21 and 65 years of age who have been diagnosed with alcoholism and anxiety issues.
- Participants must not be taking anti-anxiety medication.
Design:
- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Tests of alcohol dependency and anxiety levels will also be given.
- Participants will be divided into two groups. One group will take baclofen. The other group will have a placebo.
- About 1 week after the screening visit, participants will have a study visit. They will answer questions about their behavior and mood. They will then start to take either baclofen or a placebo. Participants will take the study drug three times a day, every day.
- After 1 week on the study drug, participants will have an overnight stay at the National Institutes of Health. They will have blood tests and answer questions about mood and behavior. They will also have tests that involve choosing to drink alcohol and answering more questions about cravings.
- Participants will stop taking their study drug over a 3-day period.
- A final follow-up visit will be required 1 week after the overnight study visit. Participants will receive information about other alcohol abuse treatment programs.
详细描述
Objective:
The selective GABAB receptor agonist baclofen has been identified as a possible medication able to reduce alcohol craving and intake in alcohol dependent individuals. In keeping with several preclinical studies, most of the clinical studies have demonstrated baclofen s effects in reducing alcohol craving and intake and promoting alcohol abstinence. However, one trial with alcoholics with a low severity of dependence found a robust treatment effect, but no differences between baclofen and placebo. The inconsistency of baclofen s effects on alcohol drinking among previous treatment trials suggests that different AD individuals may respond differently to baclofen. Baclofen has been demonstrated to consistently reduce anxiety in alcoholic patients, and analyses of positive vs. null findings with baclofen suggest that alcoholic patients with higher levels of anxiety at baseline may represent a sub-population particularly responsive to baclofen treatment. Therefore, this study will systematically test, for the first time, the specific role of baclofen on alcohol-related outcomes in alcoholic individuals with high anxiety levels. Furthermore, the biobehavioral mechanisms by which baclofen reduces drinking are not well characterized. A human laboratory pilot study conducted at Brown University with non-treatment seeking alcohol-dependent individuals suggests that baclofen reduces alcohol consumption both in the naturalistic environment as well as in a well-controlled lab setting (using an alcohol self-administration [ASA] paradigm) and that this could be mediated by baclofen s ability to alter alcohol-related biphasic effects. An exploratory analysis also revealed that specific genetic polymorphisms might moderate baclofen s effects, i.e. DRD4 and 5HTTLPR polymorphisms, although the sample of that pilot study was very small to allow one to draft definitive conclusions. The present project proposes investigating baclofen using a design similar to that used in the previous pilot study (thus, an already validated paradigm), thus representing not only the first study testing baclofen in alcoholic individuals with high anxiety levels, but also the first study investigating baclofen s biobehavioral mechanisms in such a population for which baclofen may hypothetically show a very robust effect.
Study population:
Non-treatment seeking alcohol-dependent males and females with high anxiety levels.
Design:
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Baclofen
Baclofen 10 mg t.i.d.
干预措施: Baclofen (Drug)
Placebo
Placebo t.i.d.
干预措施: Placebo (Other)
结局指标
主要结局
Total Amount of Alcohol Consumed During the Alcohol Self Administration (ASA) Session
时间窗: 2 hours
Amount of alcohol was measured as the number of mini-drinks each participant decided to drink (0-8 mini-drinks). The alcohol content of each mini-drink was calculated based on the participants' total body water, and was designed to raise the blood alcohol concentration by 0.015 g/dL.
次要结局
未报告次要终点