Alcohol Use Disorder Clinical Trial
Official title:
Doxazosin in the Treatment of Co-occuring PTSD and Alcohol Use Disorder
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.
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. ;
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