Stress Reactivity in Veterans Receiving Pharmacological Treatment for PTSD and Alcohol Dependence

Completed · Not applicable

Conditions studied: Post-traumatic Stress Disorder, Alcohol Dependence

In brief

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). Hypotheses: 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.

Key facts

Study ID

NCT00923923

Run by

Yale University

People needed

57

Starts

2009-01-01

Expected to finish

2015-07-01

Last updated by the study team

2016-12-14

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• male and female patients age 21 to 65.
• current diagnosis of DSM-IV PTSD (determined by SCID and CAPS and AD (determine by SCID)).
• participants who drink regularly (determined by TLFB and recorded 90 days prior to the interview), and are not abstinent for more than 2 weeks before participation in the study.
• are not in an active phase of alcohol withdrawal.
• are not at risk for suicide.

You may not qualify if…

• current SCID diagnosis of any psychotic disorder.
• history of substance dependence (other than alcohol and nicotine) in the last 30 days.
• current unstable medical condition such as neurological, cardiovascular, endocrine, renal, liver, or thyroid pathology (LFT 5 times normal, abnormal BUN and creatinine, and unmanaged hypertension with BP > 200/120) which in the opinion of the physician would preclude the patient from fully cooperating or be of potential harm during the course of the study.
• taking medication for a psychiatric condition.

Where it is running

• VA Connecticut Healtcase System — West Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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