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Summary

for people ages 18–69 (full criteria)
study started
estimated completion:

Description

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.

Official Title

A Randomized, Double-Blind, Placebo-Controlled Trial of Doxazosin for Nightmares, Sleep Disturbance, and Non-Nightmare Clinical Symptoms in Post-Traumatic Stress

Details

This study will involve a randomized, double-blind, placebo-controlled, flexible dose trial of doxazosin (1-16mg) for PTSD nightmares, sleep disturbance and overall PTSD symptoms. The target sample will consist of 60 male and female subjects with chronic PTSD symptoms and prominent nightmares randomly assigned to receive doxazosin (n=30) or placebo (n=30). Participants will be enrolled at the San Francisco VA Medical Center. Following baseline consent procedures, eligibility assessments, and 1-week of baseline assessments including self-report surveys and actigraphy, all subjects will initiate doxazosin or equivalently marked placebo at 1mg at bedtime. Subjects will undergo a 4-week titration phase during which doxazosin or placebo may be increased to a maximum dose of 16mg (or equivalently marked placebo) at bedtime based on symptoms and tolerability. After the 4-week titration phase, subjects will continue at stable dose of study medication for a 4-week stable dose phase. Subjects will be asked to complete sleep diaries daily during their participation in the study. In the last week of the stable dose phase, participants will undergo an additional week of at-home sleep monitoring using actigraphy, complete end of treatment surveys, and undergo end-of-treatment clinical assessments and discontinuation of study medication.

Keywords

Stress Disorders, Post-Traumatic Posttraumatic Stress Disorder Post-traumatic Stress Disorder PTSD Doxazosin Nightmares Sleep Disturbance Stress Disorders, Traumatic Dyssomnias Sleep Wake Disorders Parasomnias

Eligibility

You can join if…

Open to people ages 18–69

  • U.S. military veteran;
  • age 18-69 and
  • current full syndromal PTS as indexed by the CAPS-5 (Clinician-administered PTSD scale) or partial syndromal PTS of at least 3 months duration with a CAPS-5 score >25,and CAPS-IV recurrent distressing dreams item of >/= 5.

You CAN'T join if...

  • DSM-5 current moderate to severe alcohol or drug use disorder;
  • lifetime history of any psychiatric disorder with psychotic features, bipolar disorder, obsessive-compulsive disorder;
  • exposure to trauma within the last 3 months;
  • prominent suicidal or homicidal ideation;
  • pre-existing sleep apnea diagnosis in the absence of adherence to effective treatment(such as Continuous Positive Airway Pressure (CPAP) or oral device) or positive screen for sleep apnea by type III device;
  • neurologic disorder or systemic illness affecting central nervous system function;
  • chronic or unstable medical illness including unstable angina, myocardial infarction within the past 6 months, congestive heart failure, preexisting hypotension or baseline standing systolic blood pressure < 110 mmHg; orthostatic hypotension defined as orthostatic systolic decrease after 3 minutes standing >20 mmHg or any BP decrease accompanied by lightheadedness; heart block or arrhythmia on ECG; chronic renal or hepatic failure, and pancreatitis;
  • history of priapism;
  • pregnancy, breastfeeding and/or refusal to use effective birth control (female participants);
  • previous adverse reaction to an alpha-1-antagonist;
  • current use of trazodone, sedative-hypnotics or benzodiazepines, atypical antipsychotics, alpha-1 antagonists, alpha-2-agonists, boceprevir, midodrine; and
  • use of yohimbine, Ma huang or other non-FDA approved substances or herbal remedies that the investigators consider pose a risk to participation

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
San Francisco Veterans Affairs Medical Center
Links
Stress and Health Research Program
ID
NCT03339258
Phase
Phase 2
Lead Scientist
Anne Richards
Study Type
Interventional
Last Updated
November 7, 2017
I’m interested in this study!