Doxazosin for PTSD & Alcohol Use Disorder

Status Completed

Clinical Trial Summary

The study will test the efficacy of doxazosin, a long-acting and selective alpha-1 adrenergic antagonist, as compared to placebo in reducing PTSD symptomatology and alcohol use severity.

Clinical Trial Description

As a result of sustained operations in Afghanistan and Iraq, there are an increasing number of U.S. military personnel and Veterans at risk of developing both posttraumatic stress disorder (PTSD) and an alcohol use disorder (AUD). If left untreated, individuals with PTSD/AUD are at risk of developing other mental health problems (e.g., depression, anxiety), suicidal ideation and attempts, physical health problems, reduced resiliency, vocational problems, and family/relationship impairment. While mental health services are in place for U.S. military personnel and Veterans, there are substantial gaps in the evidence base to guide treatment of co-occurring PTSD/AUD. The proposed study directly addresses this gap by testing the efficacy of doxazosin, a long-acting and selective alpha-1 adrenergic antagonist, as compared to placebo in reducing PTSD symptomatology and alcohol use severity among U.S. military personnel (including National Guard and Reservists) who have served in Operation Enduring Freedom, Operation Iraqi Freedom, or Operation New Dawn (OEF/OIF/OND). The primary objectives of this stage II study are to evaluate the benefits of doxazosin as compared to placebo in reducing (1) PTSD symptomatology, (2) AUD severity, and (3) impairment in associated mental and behavioral health problems (e.g., depression, anxiety, sleep, risky behaviors) among OEF/OIF/OND Veterans (N=126) with co-occurring PTSD and AUD. Secondary objectives are to characterize the underlying pathophysiology of comorbid PTSD/AUD and identify prognostic indicators of treatment outcome using functional magnetic resonance imaging (fMRI). In order to accomplish this the investigators will (1) employ an intent-to-treat, double-blind, placebo-controlled randomized clinical trial that will consist of 12 weeks of treatment with doxazosin or placebo medication; (2) examine standardized, repeated dependent measures of clinical outcomes at 5 time points (baseline, week 4, week 8, week 12, and 1-month follow-up); and (3) employ advanced neuroimaging methodology. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02492334
Study type	Interventional
Source	Medical University of South Carolina
Contact
Status	Completed
Phase	Phase 2
Start date	July 2016
Completion date	December 16, 2019

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Doxazosin for PTSD and Alcohol Use Disorder

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms