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Augmentation Trial of Prazosin for Post-Traumatic Stress Disorder (PTSD)

NCT00990106 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2018-05-23

Study results available
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Summary

The purpose of this study is to determine whether prazosin will:

* reduce the incidence of nightmares and sleep disturbance
* increase functioning and sense of well being in combat-trauma exposed Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) Veterans.

Conditions

  • Stress Disorders, Post-Traumatic
  • Combat Disorders
  • Sleep Disorders

Interventions

DRUG

prazosin hydrochloride

Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually.

DRUG

placebo

placebo

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • VA Puget Sound Health Care System

    collaborator FED

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • Seattle Institute for Biomedical and Clinical Research

    lead OTHER

Principal Investigators

  • Murray Raskind, MD · Department of Veterans Affairs Puget Sound Health Care System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00990106 on ClinicalTrials.gov