A Randomized Controlled Trial of Doxazosin for Nightmares, Sleep Disturbance, and Non-Nightmare Clinical Symptoms in PTSD
NCT03339258 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2024-05-01
Summary
This randomized, double-blind, placebo-controlled trial of doxazosin will assess doxazosin's effectiveness for PTSD nightmares, subjective sleep quality, and non-nightmare PTSD symptoms in adult men and women veterans with full and partial-syndromal PTSD.
Conditions
- Stress Disorders, Post-Traumatic
Interventions
- DRUG
-
Doxazosin Mesylate, Extended Release
Doxazosin is FDA-approved for the treatment of hypertension and urinary outflow problems associated with benign prostatic hyperplasia. The immediate-release formulation is approved for use from 1mg up to 16mg. Based on drug company information and Micromedex, the SFVA pharmacy on-line reference resource for drug information, the only contraindication to use of doxazosin is hypersensitivity to doxazosin, its contents, or other quinazolines (e.g. prazosin, terazosin).
- DRUG
-
Placebo, or inactive pill.
Sponsors & Collaborators
-
United States Department of Defense
collaborator FED -
Northern California Institute of Research and Education
collaborator OTHER -
San Francisco Veterans Affairs Medical Center
lead FED
Principal Investigators
-
Anne Richards, MD, MPH · San Francisco Veterans Affairs Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-04-15
- Primary Completion
- 2024-06-30
- Completion
- 2024-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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