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NCT01338506 · ClinicalTrials.gov registry record · NA
Integrated Treatment of OEF/OIF Veterans With PTSD & Substance Use Disorders
A NA study of Alcohol Dependence and Post-Traumatic Stress Disorders, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- NA
- Development phase
- 81
- Enrollment target
- 1
- Study location
NCT01338506: Completed NA study of Alcohol Dependence and Post-Traumatic Stress Disorders, sponsored by Medical University of South Carolina.
NCT01338506 is a NA study of Alcohol Dependence and Post-Traumatic Stress Disorders that has completed, run by Medical University of South Carolina. The registered enrollment target is 81 participants, below the 312-participant average among 43 other Alcohol Dependence trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01338506, a NA study of Alcohol Dependence and Post-Traumatic Stress Disorders, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- NA
- Development phase
- 81 participants
- Enrollment target
- 1
- Study location
Study Summary
In comparison to the general population, U.S. military and Veterans are at an increased risk for developing both substance use disorders (SUD) and Post Traumatic Stress Disorder (PTSD). Current research has shown that there is a high comorbidity of SUD and PTSD, and although there are a number of treatments for SUD and PTSD independently, there are very few effective methods to simultaneously treat both disorders. Because of this substantial gap in the treatment of both SUDs and PTSD, it has become essential to develop a combined treatment that would address and treat both disorders. Individuals, specifically U.S. military and Veterans, with SUD/PTSD have unique needs that require a specialized treatment approach. This designed approach would employ cognitive-behavioral therapy (CBT) to treat the SUD, in conjunction with Prolonged Exposure therapy to treat the PTSD. Prolonged Exposure (PE) is an empirically supported and evidence-based treatment that is currently regarded as the "gold standard" psychosocial treatment for PTSD. In combination with CBT, this treatment would address both disorders in hopes of reducing substance use and PTSD symptomatology.
Primary Outcome
The hypothesis is that COPE will significantly exceed the treatment as usual control group in reducing Change in Post-traumatic Stress Disorder symptoms as measured by a reduction of 25 points or more in scores for the Clinician Administered Post-traumatic Stress Disorder Scale (CAPS). A lower Clinician Administered Post-traumatic Stress Disorder Scale and Post-traumatic Stress Disorder Checklist score would indicate less severe Post-traumatic Stress Disorder/better outcomes. A negative sign i
Conditions Studied
Interventions
- BEHAVIORAL Concurrent Treatment with Prolonged Exposure (COPE)
Study Locations (1)
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2011-04 |
| Est. Completion | 2016-03 |
| Phase | NA |
What the finished NCT01338506 record still lists
NCT01338506 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 312-participant average among 43 other Alcohol Dependence trials with a reported enrollment target (74% lower).
The record links to 4 conditions, with Alcohol Dependence appearing as the primary indexed condition, and to 1 intervention - of which Concurrent Treatment with Prolonged Exposure (COPE) is the first listed.
NCT01338506 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT01338506 about?
NCT01338506 is a clinical study titled "Integrated Treatment of OEF/OIF Veterans With PTSD & Substance Use Disorders". In comparison to the general population, U.S. military and Veterans are at an increased risk for developing both substance use disorders (SUD) and Post Traumatic Stress Disorder (PTSD). Current research has shown that there is a high comorbidity of SUD and PTSD, and although there are a number of tr...
What is the current status of trial NCT01338506?
This trial is currently completed. It is a NA study. The enrollment target is 81 participants. The study started on 2011-04. Estimated completion is 2016-03.
What conditions does trial NCT01338506 study?
This clinical trial studies the following conditions: Alcohol Dependence, Post-Traumatic Stress Disorders, Drug Dependence, Combat Disorders.
What interventions are being tested in trial NCT01338506?
The interventions under investigation include: Concurrent Treatment with Prolonged Exposure (COPE) (BEHAVIORAL).
Who is sponsoring clinical trial NCT01338506?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01338506 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01338506's enrollment target sits among peer trials
81 25th of 43 higher than 19 of 43 other Alcohol Dependence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol Dependence trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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