Does Propranolol, a Beta Blocker, Attenuate Stress-Induced Drinking?
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Alcohol consumption
研究概览
简要总结
For this protocol, the investigators plan to conduct a pilot study evaluating the effect of propranolol on alcohol consumption. Using a parallel design, the investigators plan to randomize 20 non-treatment seeking adults with alcohol use disorders (DSM-5) to propranolol extended release (160mg/day or placebo; n=10 per cell) to evaluate whether propranolol reduces alcohol self-administered in the laboratory. Importantly, the investigators will evaluate whether propranolol counteracts stress-induced effects on alcohol self-administration. Following titration to steady state medication levels over a 2-week period, each subject will complete two laboratory sessions consisting of a well validated method for inducing stress or neutral/relaxing state (order counterbalanced), followed by a 2-hour alcohol self-administration paradigm known to be sensitive to medication effects.
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
- 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
- •Able to read and write English
- •Meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for current (past 6 months) alcohol use disorders
- •Able to take oral medications and willing to adhere to medication regimen
排除标准
- •Participants with any significant current medical conditions.
- •Women who are pregnant or nursing, or fail to use one of the following methods of birth control unless she or partner is surgically sterile or she is postmenopausal (hormone contraceptives [oral, implant, injection, patch, or ring], contraceptive sponge, double barrier [diaphragm or condom plus spermicide], or IUD)
- •Suicidal, homicidal or evidence of current (past 6-month) mental illness.
- •Specific exclusions for administration of propranolol not already specified.
- •Subjects likely to exhibit clinically significant alcohol withdrawal during the study.
研究组 & 干预措施
Placebo
Administered orally once daily at 10:00PM
干预措施: Placebo (Drug)
Propranolol
Propranolol extended release (160mg/day). Administered orally once daily at 10:00PM. Titration schedule Days 1-3 60mg, Days 4-7 80mg, Days 8-11 120mg, and Days 12-14 160mg until steady state.
干预措施: Propranolol (Drug)
结局指标
主要结局
Alcohol consumption
时间窗: 120 minutes
Mean mls of alcohol consumed (maximum of 120 mg/dL) for propranolol and placebo groups during 120 minute alcohol self administration sessions taking place as close to Day 15 and Day 19 as possible of medication dosing.
次要结局
未报告次要终点