Augmentation Trial of Prazosin for Post-Traumatic Stress Disorder (PTSD)

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether prazosin will:

• reduce the incidence of nightmares and sleep disturbance

• increase functioning and sense of well being in combat-trauma exposed Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) Veterans.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seattle Institute for Biomedical and Clinical Research
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); United States Department of Defense; VA Puget Sound Health Care System
• Treatments: Prazosin

Criteria

Inclusion Criteria

• Age >18 years;

• Clear evidence of exposure to one or more war zone trauma events sufficient to satisfy DSM-IV criterion A1 for diagnosis of PTSD;

• DSM-IV diagnosis of PTSD derived from the CAPS; CAPS total score >50;

• CAPS Recurrent Distressing Dreams item score >5 (of maximum score of 8);

• stable dose of non-exclusionary medications and psychotherapeutic treatment for at least 4 weeks prior to randomization;

• good general medical health.

• Female participants must agree to use a reliable form of birth control during the study.

Exclusion Criteria

• Psychiatric/Behavioral - meets DSM-IV criteria for current schizophrenia, schizoaffective disorder, psychotic disorder, delirium, or any DSM-IV cognitive disorder; substance dependence disorder within 3 months or any current substance dependence; current cocaine or stimulant abuse; severe psychiatric instability or severe situational life crises, including evidence of being actively suicidal or homicidal, or any behavior which poses an immediate danger to patient or others.

• Medical - acute or unstable chronic medical illness, including unstable angina, recent myocardial infarction (within 6 months), congestive heart failure, preexisting hypotension or orthostatic hypotension, chronic renal or hepatic failure, pancreatitis, Meniere's disease, benign positional vertigo; narcolepsy, or diagnosed sleep apnea; allergy or previous adverse reaction to prazosin or other alpha-1 antagonist.