Status:
ACTIVE_NOT_RECRUITING
A Randomized Controlled Trial of Doxazosin for Nightmares, Sleep Disturbance, and Non-Nightmare Clinical Symptoms in PTSD
Lead Sponsor:
San Francisco Veterans Affairs Medical Center
Collaborating Sponsors:
United States Department of Defense
Northern California Institute of Research and Education
Conditions:
Stress Disorders, Post-Traumatic
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 a...
Detailed Description
This study will involve a randomized, double-blind, placebo-controlled, flexible dose trial of doxazosin (1-10mg) for PTSD nightmares, sleep disturbance and overall PTSD symptoms. The target sample wi...
Eligibility Criteria
Inclusion
- U.S. military veteran or civilian;
- age 18-75 and
- current full syndromal PTS as indexed by the CAPS-5 (Clinician-administered PTSD scale) or have a current CAPS-5 score ≥ 20, and CAPS-IV recurrent distressing dreams item of ≥ 3; or a CAPS-5 score ≥ 12, and CAPS-IV recurrent distressing dream item of ≥ 4.
Exclusion
- DSM-5 current moderate to severe alcohol or drug use disorder in the last 3 months; moderate alcohol or drug use disorder in the last 3 months will be reviewed on a case-by-case basis;
- 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;
- score of 16 or greater AHI based on ApneaLink data analysis in the absence of effective sleep treatment (such as CPAP or oral 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 standing systolic blood pressure \< 100 mmHg at eligibility (V0); 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 or refusal to hold off on as needed phosphodiesterase inhibitors;
- pregnancy, breastfeeding and/or refusal to use effective birth control (female participants);
- previous adverse reaction to an alpha-1-antagonist;
- current use of a medication with alpha-1 blocking properties for insomnia, 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.
Key Trial Info
Start Date :
April 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03339258
Start Date
April 15 2018
End Date
June 1 2024
Last Update
May 1 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
San Francisco VA Medical Center
San Francisco, California, United States, 94121