A Randomized, Double-Blind, Placebo-Controlled Trial of Doxazosin for Nightmares, Sleep Disturbance, and Non-Nightmare Clinical Symptoms in Post-Traumatic Stress
Technical Report,15 Jun 2018,14 Jun 2019
Northern California Institute for Research and Education Inc San Francisco United States
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Posttraumatic Stress PTS is a condition that may develop after highly stressful life events and affects 8-10 of adults in theU.S. civilian population and up to 30 of soldiers exposed to combat. We are conducting a randomized, double-blind, placebo-controlled trial design to more definitively demonstrate doxazosins clinical benefits for PTS nightmares, non-nightmare sleep disturbance, and overall PTS symptoms. To assess the effects of doxazosin on the main outcome of interest, PTS nightmares, eligibility will be based on the presence of PTS nightmares in the setting of full- or partial-syndromal PTS. We are using flexible dose design of doxazosin with a 4-week titration phase followed by a 4-week steady-dose phase. The primary scientific aims of our study are as follows 1 To assess the effects of doxazosin, in comparison to placebo, on sleep disturbance and clinical symptoms of PTS through measures of nightmares, subjective sleep quality, and non-nightmare PTS symptoms, in adult men and women with chronic PTS 2 To examine the effects of doxazosin on an objective measure of sleepwake activity in adult men and women with chronic PTS 3 To examine the effects of doxazosin, as compared to placebo, on depression symptoms, sexual health, and overall quality of life.