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

Palo Alto (17 mi)

Overseen byAnne Richards, MD, MPH

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: San Francisco Veterans Affairs Medical Center

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adult veterans aged 18-75 with PTSD, experiencing nightmares and sleep issues. They can be on certain stable medications like SSRIs but not undergoing specific psychotherapies during the trial. Exclusions include recent trauma, severe substance abuse, psychosis or mania history, unstable medical conditions like heart failure or low blood pressure, pregnancy, and those unsuitable as per investigator's judgment.

Exclusion Criteria

I have a condition affecting my brain or nervous system.

I am currently taking medications that have specific effects.

I am not using any non-FDA approved substances or herbal remedies.

My sleep study shows I have moderate to severe sleep apnea without treatment.

I do not have any unstable heart, kidney, liver, or pancreas conditions.

Treatment Details

The study tests Doxazosin Mesylate's effectiveness against placebo in reducing PTSD-related nightmares and improving sleep quality. It's a randomized controlled trial where participants don't know if they're getting the actual drug or a dummy pill to ensure unbiased results.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Doxazosin Mesylate, Extended ReleaseExperimental Treatment1 Intervention

Subjects will undergo a 4-week titration phase during which doxazosin may be increased to a maximum dose of 10mg 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.

Group II: PlaceboPlacebo Group1 Intervention

Subjects will undergo a 4-week titration phase during which the placebo may be increased to a maximum dose of 10mg at bedtime based on symptoms and tolerability. After the 4-week titration phase, subjects will continue at stable dose of study placebo for a 4-week stable dose phase.