NCT00744055

Prazosin for Treatment of Patients With Alcohol Dependence (AD) and Post Traumatic Stress Disorder (PTSD).

The Use of Prazosin for Treatment of Patients With Alcohol Dependence (AD) and Post Traumatic Stress Disorder (PTSD).

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Prazosin is an alpha-1 adrenergic receptor antagonist that has been used successfully in the treatment of trauma nightmares and sleep disturbance in combat veterans with PTSD, and alcohol dependence. The objective of this study is to evaluate the efficacy of prazosin (16mg) versus placebo in reducing alcohol consumption and decreasing symptoms of PTSD in patients with comorbid AD and PTSD.

Detailed description

Background: There is a high rate of comorbidity with alcohol dependence (AD) and post traumatic stress disorder (PTSD). The rates of PTSD among individuals with AD are at least twice as high as those in the general population. In addition, alcohol dependence is the most common comorbid condition in men with PTSD. Despite this, little is known about how to best treat individuals with comorbid AD and PTSD. The use of an alpha-1 adrenergic receptor antagonist represents a novel approach to treatment that may target symptoms of both AD and PTSD. There is evidence of common neurobiological mechanisms that underlie both AD and PTSD. Prazosin is an alpha-1 adrenergic receptor antagonist that has been used successfully in the treatment of trauma nightmares and sleep disturbance in combat veterans with PTSD, and alcohol dependence. Objective: The objective of this study is to evaluate the efficacy of prazosin (16mg) versus placebo in reducing alcohol consumption and decreasing symptoms of PTSD in patients with comorbid AD and PTSD. Methods: Thirty participants with a current diagnosis of AD and PTSD will be enrolled in a 13-week trial. They will be assigned, in a double-blind fashion, to either prazosin or placebo. Significance: This project will be the first to compare prazosin to placebo as effective treatments for reducing alcohol consumption and PTSD symptoms in patients with both AD and PTSD.

Conditions

• Alcohol Dependence
• Stress Disorders, Post-Traumatic

Interventions

Type	Name	Description
DRUG	Prazosin	prazosin (16mg/day) 2 times a day
DRUG	Placebo	Placebo

Timeline

• Start date: 2009-01-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2008-08-29
• Last updated: 2020-03-19
• Results posted: 2016-01-18

Locations

1 site across 1 country: United States