A Double-Blind Placebo-Controlled Trial of Prazosin for the Treatment of Alcohol Dependence
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Number of drinks per drinking day consumed
研究概览
简要总结
This double-blind placebo controlled pilot trial will test the hypothesis that prazosin, an alpha-1 adrenergic receptor antagonist, reduced alcohol consumption and alcohol craving in alcohol dependent individuals without Post Traumatic Stress Disorder (PTSD). The intervention period is six weeks.
详细描述
The objective of the project is to determine whether prazosin, an alpha-1 adrenergic receptor antagonist, decreases alcohol consumption and/or the subjective experience of alcohol craving in individuals without post-traumatic stress disorder (PTSD) who are seeking treatment for alcohol dependence.
The study hypotheses are: (1) Subjects treated with prazosin will report fewer drinking days and fewer drinks per drinking day than subjects treated with placebo, (2) subjects treated with prazosin will report decreased craving for alcohol as compared to subjects in the placebo condition, and (3) prazosin will be well-tolerated at the proposed dosage by subjects in the prazosin condition compared to subjects in the placebo condition.
This project is a double-blind, randomized, placebo-controlled trial of prazosin in subjects who are dependent on alcohol and have used alcohol within the last 30 days prior to randomization. The treatment phase will last 6 weeks and will include 40 subjects; 20 randomized to each experimental condition (prazosin and placebo). Participants in both the groups will be provided the same behavioral treatment for alcohol dependence throughout the course of the study. Participants in both groups will also use daily Interactive Voice Response (IVR) symptom monitoring technology to track daily fluctuations in alcohol use and craving, as well as medication compliance.
The study will be conducted at the Addiction Treatment Center (ATC) at VAPSHCS, Seattle division.
Participants will include 40 alcohol-dependent adults presenting for chemical dependency treatment at the VA Puget Sound Health Care System (VAPSHCS) Addiction Treatment Center as well as subjects recruited from the general public via advertisements in local weekly newspapers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 years of age or older
- •current DSM-IV diagnosis of alcohol dependence with some use in last 30 days
- •capacity to provide informed consent
- •no planned absences during six week active treatment period that would prevent weekly check-in wiht the study psychiatrist
- •English fluency
排除标准
- •Score 50 or greater on the PTSD Check List which suggests a current diagnosis of PTSD
- •Psychiatric disorder requiring any medication other than anti-depressants
- •Current diagnosis of opiate dependence or abuse, chronic treatment with any opiate-containing medications during the previous month, or urine positive for opioids
- •Significant acute or chronic medical illness, including unstable angina, recent myocardial infarction, history of congestive heart failure, preexisting hypotension (systolic lower than 110) or orthostatic hypotension (systolic drop greater than 20mmHg after two minutes standing or any drop with dizziness), insulin-dependent diabetes mellitus; chronic renal or hepatic failure, pancreatitis, gout, Meniere's disease, benign positional vertigo, narcolepsy
- •Concomitant use of trazodone, tadalafil or verdenafil
- •History of prazosin-sensitivity
- •Women who are pregnant, nursing infant(s), or of childbearing potential and not using a contraceptive method judged by the investigator to be effective
- •Signs or symptoms of alcohol withdrawal at the time of randomization
研究组 & 干预措施
2
干预措施: prazosin (Drug)
结局指标
主要结局
Number of drinks per drinking day consumed
时间窗: 6 weeks
Number of days drinking during the six week intervention
时间窗: 6 weeks
次要结局
- Daily craving intensity over the six week intervention(six weeks)