Ignite Creation Date:
2024-05-06 @ 7:15 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02500602
Status:
COMPLETED
Last Update Posted:
2021-05-13
First Post:
2015-07-07
Brief Title:
CAP Doxazosin in the Treatment of Co-Occurring PTSD and Alcohol Use Disorders
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CAP - Doxazosin in the Treatment of Co-Occurring PTSD and Alcohol Use Disorders
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Doxazosin
Brief Summary:
The proposed study will examine the efficacy of doxazosin in the treatment of PTSD and alcohol use disorder or substance use disorders
Detailed Description:
Due to sustained military conflicts in Afghanistan and Iraq over the past decade there are an increasing number of US military personnel and Veterans returning home with posttraumatic stress disorder PTSD and comorbid alcohol use disorders AUD and substance use disorders SUD If left untreated Veterans with co-occurring PTSD and substance use disorders are at increased risk for developing other mental health problems eg depression anxiety suicidal ideation and attempts physical health problems reduced resiliency and military readiness employment problems violence and familyrelationship impairment While mental health services are in place for US service members substantial gaps in the treatment of co-occurring PTSD and SUD exist and there is little scientific evidence available to guide the provision of care As part of the Consortium to Alleviate PTSD CAP the proposed study directly addresses this critical knowledge gap by testing the efficacy of doxazosin a long-acting and selective alpha-1 adrenergic antagonist as compared to placebo in reducing PTSD and AUDSUD severity among US military personnel The medication to be investigated doxazosin represents a novel treatment approach for PTSD and AUDSUD While prazosin also an alpha-1 adrenergic antagonist has been shown to improve sleep and nightmares in military personnel with PTSD and may help reduce substance use severity it has a short half-life of 2-3 hours and requires multiple doses each day which is a significant limitation In several pilot studies doxazosin has shown promise in significantly reducing symptoms of PTSD and AUDSUD and in contrast to prazosin it requires once per day dosing which confers a significant advantage in terms of translating positive findings into routine clinical practice In this Stage II study the investigators will 1 employ a two-arm randomized double-blind between-groups experimental design that will consist of 12 weeks of treatment with doxazosin or placebo medication 2 use standardized repeated dependent measures to rigorously assess PTSD symptomatology and AUDSUD severity 3 measure impairment in associated mental and behavioral health problems eg depression anxiety sleep risky behaviors familysocial functioning and 4 use functional magnetic resonance imaging fMRI to investigate the underlying pathophysiology of comorbid PTSDAUD and identify prognostic indicators of treatment outcome To achieve these aims the investigators have assembled a multidisciplinary team of investigators with nationally-recognized expertise in combat-related PTSD substance use disorders and neuroimaging who have successfully collaborated in the past and are uniquely qualified to implement this type of investigation The investigators represent a collaboration of faculty at the Ralph H Johnson Veterans Affairs VA Medical Center and the Medical University of South Carolina MUSC in Charleston SC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CX001288 | OTHER_GRANT | VADoD | None |