VA Cooperative Studies Program (CSP)

Investigator Access

What's Available

Check with the study contact and publication for information on a public dataset, data archive, data enclave, or website where data might be available.

Available Documentation

Dates Data are Available

Access Criteria

Study Characteristics

Objectives

Primary objective:

To evaluate efficacy of prazosin after 10 weeks of treatment for the primary outcomes of

1. Reducing trauma-related nightmares
2. Improving sleep quality
3. Improving global clinical status in Veterans with chronic PTSD caused by life-threatening war zone trauma

The efficacy of prazosin will also be evaluated for secondary outcomes of reducing total PTSD symptoms (both nighttime and daytime), reducing comorbid depressive symptoms, and improving quality of life and health-related quality of life.

Secondary objective:

To evaluate long-term effectiveness of prazosin after 26 weeks of treatment for continuing to improve the primary and secondary outcomes measures.

Era of Service

All

Population

Veterans 18 years of age or older (97.7% male) exposed to life-threatening war zone trauma who have frequent, distressing, and persistent trauma-related nightmares. 

Trauma-related nightmares present for at least one month and sufficient frequency and severity to score 5 or greater on the Clinician Administered PTSD Scale (CAPS) Recurrent Distressing Dreams item and the Distressing Dreams frequency must be a score of 2 or greater. Veterans who experienced terrifying life-threatening war zone trauma in non-combat roles or as the result of accidents may be included with approval of the Study Chairpersons.

Study Design

Randomized, parallel design, double-blind, placebo-controlled

Intervention

Intervention: Prazosin

Control: Placebo

Time Period

Jan 2010 – May 2013

Setting

National

N

304 participants

Response Rate

Unconfirmed

Recruitment Methods

• Referrals from Mental Health services or other clinics of participating sites and VA community-based outpatient clinics
• Advertisements to reach eligible Veterans in the community who do not currently receive care at a VA facility

Compensation

$25/visit for time and travel expenses; up to $375

Data Collected

• Demographics
• Physical and psychological characteristics
• Recurrent distressing dreams
• Sleep quality
• Well-being
• Ability to function

Specific instruments used:

• Combat Experiences Scale
• Structured Clinical Interview for DSM-IV (SCID-IV)
• Clinician-Administered PTSD Scale for DSM-IV (CAPS)
• Clinical Global Impression of Change (CGIC)
• CAPS Recurrent Distressing Dreams item
• PTSD Checklist (PCL-M [military version])
• Pittsburg Sleep Quality Index (PSQI)
• Patient Health Questionnaire-9 (PHQ-9)
• Quality of Life Inventory (QOLI)
• Health-Related Quality of Life (SF-12V)
• Alcohol Use Disorders Identification Test-Consumption Questions (AUDIT-C)

Data Collection Methods

• Structured questionnaires
• Structured clinical interviews
• Assessments

Funding Sources

VA Cooperative Studies Program (CSP)

Investigators

Murray A. Rasking, MD

Elaine R. Peskind, MD

Contact

Project manager: Beverly Ventura; Beverly.Ventura@va.gov

Selected Publications

Raskind MA, Pesking ER, Chow B, Harris C, Davis-Karim A, Holmes HA, Hart KL, McFall M, Mellman TA, Resist C, Romesser J, Rosenheck R, Shih MC, Stein MC, Swift R, Gleason T, Lu Y, Huang GD. Trial of prazosin for post-traumatic stress disorder in military Veterans. N Engl J Med. 2018 Feb 8;378(6):507-517. doi: 10.1056/NEJMoa1507598

More Information

Study webpage

ClinicalTrials.gov identifier: NCT00532493