Stress Reactivity in Veterans Receiving Pharmacological Treatment for Post-traumatic Stress Disorder (PTSD) and Alcohol Dependence
What is the purpose of this trial?
Method: This study is designed as an accompaniment to an already funded study - a 12-week treatment trial with prazosin for patients with PTSD and AD.
The study design will consist of III phases. In phase I, all subjects will participate in three laboratory sessions to determine their reactivity to stress. Stress reactivity will be measured using: traumatic experiences, stressful non-trauma experiences and neutral experiences, presented randomly. Laboratory sessions will be conducted in an outpatient setting. Phase II is a randomized clinical trial evaluating prazosin versus placebo for 12 weeks in a double-blind, controlled fashion in an outpatient setting. The treatment will last for 12 weeks and outcomes will include symptoms of PTSD and alcohol use. In phase III, subjects will again participate in a laboratory session. This phase of the study will be conducted after at least 6 weeks of treatment while patients are on medication (prazosin or placebo).
Primary: The investigators hypothesize that prazosin will be more effective than placebo in reducing trauma-related stress reactivity in a laboratory paradigm, particularly anxiety, craving for alcohol, and hormonal response, in individuals with PTSD and AD.
Secondary: The investigators hypothesize that stress reactivity will have a moderating effect on treatment with prazosin, such that individuals with high levels of stress reactivity will have fewer heavy drinking days, a significant reduction in PTSD symptoms, and shorter time to relapse than individuals with low levels of stress reactivity.
- 21 Years - 65 Years
- Elizabeth Ralevski
- January 2009
- Last Updated:
- April 16, 2013
- Study HIC#:
Clinicaltrials.gov ID: NCT00923923