Clinical Trial: Prazosin Alcohol Dependence IVR Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Double-Blind Placebo-Controlled Trial of Prazosin for the Treatment of Alcohol Dependence

Brief Summary: 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.

Detailed Summary:

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 i
Sponsor: University of Washington

Current Primary Outcome:

  • Number of days drinking during the six week intervention [ Time Frame: 6 weeks ]
  • Number of drinks per drinking day consumed [ Time Frame: 6 weeks ]


Original Primary Outcome:

  • Number of days drinking during the six week intervention
  • Number of drinks per drinking day consumed


Current Secondary Outcome: Daily craving intensity over the six week intervention [ Time Frame: six weeks ]

Original Secondary Outcome: Daily craving intensity over the six week intervention

Information By: University of Washington

Dates:
Date Received: September 9, 2005
Date Started: September 2005
Date Completion:
Last Updated: February 13, 2008
Last Verified: February 2008