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CAP: Doxazosin in the Treatment of Co-Occurring PTSD and Alcohol Use Disorder (PATRIOT Study)

Principal Investigator: Sudie E. Back, PhD
Aim: Determine the efficacy of the medication doxazosin in reducing the severity of posttraumatic stress disorder and alcohol/substance use in veterans with both PTSD and alcohol/substance use disorder; establish guidelines for measuring progress during clinical trials involving veterans with those disorders.
Post-911 deployments have left an increasing number of U.S. military personnel and veterans at risk of developing posttraumatic stress disorder (PTSD) and substance use disorders. The most common substance use problem among veterans is alcohol use disorder (AUD).

Co-occurring PTSD and alcohol/substance use disorder (AUD/SUD) complicates treatment of both conditions, but medical professionals have little scientific evidence to guide patient care.

Principal Investigator Sudie E. Back, PhD, of the Ralph H. Johnson VA in Charleston, South Carolina, and the Medical University of South Carolina, and her research team are addressing that knowledge gap with this study for the Consortium to Alleviate PTSD. They will test the efficacy of doxazosin, as compared to placebo, in reducing PTSD and alcohol/substance use severity.

Although doxazosin normally is prescribed to treat high blood pressure and enlarged prostate, the drug has shown promise in pilot studies in significantly reducing symptoms of PTSD and AUD.

Study participants will be selected randomly to receive either doxazosin or a placebo over a 12-week period, with periodic measurements of PTSD symptoms and substance use. All patients will have the option of receiving cognitive behavioral therapy to help reduce alcohol or drug use during the trial.

Assessments will include optional functional magnetic resonance imaging (fMRI) before and after the study to examine physical characteristics of comorbid PTSD and AUD/SUD in the brain, as well as changes over time that indicate positive response to treatment.

This study features a multidisciplinary team of investigators with nationally recognized expertise in combat-related PTSD, alcohol/substance use disorders, and neuroimaging who have successfully collaborated in the past. The investigators represent a collaboration of faculty at the Medical University of South Carolina and the Ralph H. Johnson Veterans Affairs Medical Center in Charleston, SC.

Expected benefits

The findings from this study may open a new avenue for treatment of the common and complex comorbidity of PTSD and substance use disorder. It has the potential to significantly improve the standard of patient care, advance the science in this area, decrease public health expenditures, and improve the military readiness and overall health of U.S. military personnel, veterans, and their families.

Version: 05/25/2017

PI: SudieBack, PhD
Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, and the Medical University of South Carolina

Study Sites:
Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC
Savannah VA Outpatient Clinic, Savannah, GA

On-Site Principal Investigator or Military Collaborator:
Sudie E. Back, PhD

Funding Source:
U.S. Departments of Defense and Veterans Affairs, Consortium to Alleviate PTSD award

Status of Study:
Enrollment complete

Participants:
Veterans with co-occurring PTSD and alcohol or substance use disorder

For more information on study participation, contact:


Noel Mazzulo - Charleston
(843) 577-5011 ext. 1-5335 (VA) or
(843) 876-0736 (MUSC)

mazzulo@musc.edu

Michelle Pompei - Savannah
(912) 920-0214, ext. 2169

pompei@musc.edu



Media Contact:
media@strongstar.org

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