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Alpha-1 Adrenergic Receptor Antagonist

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

Phase 2

Waitlist Available

Led By Anne Richards, MD, MPH

Research Sponsored by San Francisco Veterans Affairs Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Neurologic disorder or systemic illness affecting central nervous system function

Current use of specific medications with certain properties

Timeline

Screening 3 weeks

Treatment Varies

Follow Up all subjects will wear the actigraph daily for 7 days at pre-treatment baseline (week 0), 7 days in week 5 of study drug treatment, and at end-of-treatment week 8 prior to drug discontinuation.

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

This trial will assess doxazosin's effectiveness for treating nightmares, sleep quality, and other PTSD symptoms in adult male and female veterans with PTSD.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Doxazosin may cause side effects such as low blood pressure when standing up (orthostatic hypotension), dizziness due to this drop in blood pressure, potential heart rhythm problems (as seen by exclusion criteria), and possibly other mild to moderate symptoms.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition affecting my brain or nervous system.

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I am currently taking medications that have specific effects.

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

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ all subjects will wear the actigraph daily for 7 days at pre-treatment baseline (week 0), 7 days in week 5 of study drug treatment, and at end-of-treatment week 8 prior to drug discontinuation.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~all subjects will wear the actigraph daily for 7 days at pre-treatment baseline (week 0), 7 days in week 5 of study drug treatment, and at end-of-treatment week 8 prior to drug discontinuation.

This trial's timeline: 3 weeks for screening, Varies for treatment, and all subjects will wear the actigraph daily for 7 days at pre-treatment baseline (week 0), 7 days in week 5 of study drug treatment, and at end-of-treatment week 8 prior to drug discontinuation. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in CAPS PTS Symptom Score

Change in Clinician Administered PTSD Scale (CAPS) Distressing Dream Score

Change in Pittsburgh Sleep Quality Index (PSQI)

Secondary study objectives

Change in minutes of wake after sleep onset (WASO)

Change in sleep maintenance (SM)

Change in total sleep time (TST)

+5 more

Other study objectives

Beck Depression Inventory (BDI)

Female Sexual Functioning Index (FSFI)

Male Sexual Health Questionnaire (MSHQ)

+2 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

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.

0 / 5Eligibility criteria met