A Randomized Controlled Trial of Doxazosin for Nightmares, Sleep Disturbance, and Non-Nightmare Clinical Symptoms in PTSD

• Status: Unknown status
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: San Francisco Veterans Affairs Medical Center
• Collaborators: Northern California Institute of Research and Education; United States Department of Defense
• Treatments: Doxazosin

Criteria

Inclusion Criteria:

• U.S. military veteran;

• age 18-75 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 >20, and CAPS-IV recurrent distressing dreams item of >/= 3.

Exclusion Criteria:

• DSM-5 current moderate to severe alcohol or drug use disorder in the last 3 months;

• history of any psychiatric disorder with active psychosis or mania in the past 5 years;

• 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; complete 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

• homelessness (includes living in a temporary shelter);

• subjects who, in the opinion of the investigator, are otherwise unsuitable for a study of this type.

Participants taking SSRIs, duloxetine, bupropion, mirtazapine, and venlafaxine may be included if they have been on a stable dose for 4 weeks. Participants may be included if they are in psychotherapy treatment as long as they do not participate in evidence-based trauma-focused or nightmare-focused psychotherapy (such as cognitive processing therapy, prolonged exposure therapy, or imagery rehearsal therapy) while in the trial. Participants who are normotensive and do not have orthostatic hypotension while on stable-dose beta-blocker may be included in the study.