Prazosin Treatment for Combat Trauma PTSD (Post-Traumatic Stress Disorder) Nightmares and Sleep Disturbance

Completed · Phase 4

Conditions studied: Stress Disorder, Post-Traumatic

In brief

The purpose of this study is to determine whether prazosin will reduce the incidence of nightmares, sleep disturbance, and overall symptoms in combat trauma-exposed individuals with PTSD.

Key facts

Study ID

NCT00108420

Run by

US Department of Veterans Affairs

Starts

2003-10-01

Expected to finish

2007-03-01

Last updated by the study team

2009-01-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Combat-trauma exposed persons with a diagnosis of PTSD
• No diagnosis of lifetime schizophrenia, schizoaffective disorder, bipolar disorder, psychotic disorder, or any DSM-IV cognitive disorder; current delirium, or substance dependence disorder within 3 months of the study or current substance use other than alcohol (no more than 2 drinks/day); severe psychiatric instability or situational life crises, including evidence of being actively suicidal or homicidal, or any behavior which poses an immediate danger to patient or others
• In good general medical health (no acute or significant chronic medical illness, including unstable angina, recent myocardial infarction, history of congestive heart failure, preexisting hypotension [systolic <110] or orthostatic hypotension [systolic drop > 20 mmHg after two minutes standing or any drop with dizziness]; insulin-dependent diabetes mellitus; chronic renal or hepatic failure, pancreatitis, gout, Meniere's disease, benign positional vertigo, narcolepsy, allergy or previous adverse reaction to prazosin or other alpha-1 antagonist, or any unstable medical condition).
• Stable dose of nonexcluded medications for concurrent stable medical conditions for at least 4 weeks prior to randomization.
• Specific criteria used to validate presence of combat stress-related nightmares and sleep disturbance will include: score > 5 (of a maximum score of 8) on the CAPS Recurrent Distressing Dreams item. (CAPS score >5 places subjects in the upper third of nightmare severity) or score > 5 (of a maximum score of 8) on the CAPS Difficulty Falling or Staying Asleep item.

Where it is running

• VA Puget Sound Health Care System — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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