Neural Mechanisms of Change During the Treatment of Alcohol Use Disorders With Prazosin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Number of Standard Alcoholic Drinks Consumed Per Week (Drinks Per Week)
研究概览
简要总结
The study uses neurobiological measures through brain imaging, neuropsychological measures, and selfreport measures to try to understand how an effective treatment for alcoholism works. On the whole, less than 50% of people with alcoholism get better with treatment. This study will help researchers develop better treatments for alcoholism because if the investigators know why the treatments the investigators use are working, and in whom the treatments work best, then the investigators may be able to make treatment more effective by targeting treatments to individuals who would be most likely to benefit and by guiding development of more effective treatments in the future.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females age 18-65 meeting DSM-IV criteria for alcohol dependence in the past year;
- •seeking but not currently receiving treatment;
- •able to provide voluntary informed consent;
- •have at least 4 drinking days in the past 30 days
- •english-speaking
- •have a primary care physician or psychiatrist willing to continue prazosin if the patient tolerates it well and is finding it beneficial.
排除标准
- •severe neurological (e.g., head injury/stroke) conditions, Meniere's disease, narcolepsy, benign positional vertigo, heart disease or unstable angina, history of dysrhythmia/syncope, SBP<110, SBP>160, DBP>110, HR<55, HR>110, irregular heart rhythm, chronic renal or hepatic failure, pancreatitis or insulin-dependent diabetes, or other medical problems requiring immediate attention;
- •schizophrenia, schizoaffective disorder, PTSD, Bipolar I disorder, suicidal thoughts within the last month;
- •current dependence on another drug of abuse (except nicotine);
- •contraindications to MRI (e.g., pacemaker);
- •active legal problems with the potential to result in incarceration;
- •pregnancy or lactation, or child bearing age and not on birth control;
- •currently receiving treatment for alcohol dependence;
- •current use of psychoactive medications including SSRI's and other antidepressants, anti-craving medications, anxiolytics including benzodiazepines, antipsychotics, mood stabilizers or anticonvulsants;
- •history of seizures or DT's during alcohol withdrawal.
研究组 & 干预措施
Prazosin
Prazosin titrated to 16 mg daily x 6 weeks
干预措施: Prazosin (Drug)
Placebo
Placebo X 6 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Standard Alcoholic Drinks Consumed Per Week (Drinks Per Week)
时间窗: from 2-4 weeks and from 4-6 weeks
次要结局
未报告次要终点
研究者
Claire E Wilcox
MD
University of New Mexico