Concurrent Treatment for Substance Dependent Individuals With Post-Traumatic Stress Disorder (PTSD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01365247|
Recruitment Status : Completed
First Posted : June 3, 2011
Last Update Posted : May 14, 2015
|Condition or disease||Intervention/treatment||Phase|
|Stress Disorders, Post-Traumatic Substance-Related Disorders||Behavioral: Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure Behavioral: Relapse Prevention Treatment Behavioral: Active Monitoring Control Group||Not Applicable|
This study will enhance the knowledge and understanding of concurrently treating individuals with substance use disorders and PTSD in hopes of facilitating treatment retention and increasing the likelihood for more positive treatment outcomes. Following NIDA's stage model for behavior therapies development, this study will take the next step building upon promising findings from Stage IA work with an exposure-based therapy modified to use safely with substance dependent individuals.
This study is a randomized clinical trial to assess the relative efficacy of two active treatment conditions versus an active monitoring control group for substance dependent individuals who also meet criteria for current PTSD according to the diagnostic standards set by the DSM-IV. Eligible participants will be randomly assigned to either: (1) Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE); (2) Relapse Prevention Treatment (RPT) or an (3) Active Monitoring Control Group (AMCG). The study is a three armed randomized controlled trial with repeated outcome measures at post treatment and 1-,2-, and 3-months post-treatment follow-up points for participants in COPE and RPT.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Randomized Trial of Concurrent Treatment for PTSD and Substance Dependence|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure
Behavioral: Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure
A manualized, twelve-week intervention applying cognitive-behavioral strategies and prolonged exposure (PE) techniques to address substance use and trauma related issues.
Active Comparator: RPT
Relapse Prevention Therapy
Behavioral: Relapse Prevention Treatment
Relapse Prevention Treatment is a cognitive-behavioral skills training approach to initiating and maintaining substance use-related goals.
|Active Comparator: Active Monitoring Control Group||
Behavioral: Active Monitoring Control Group
Participants meet with study staff on a weekly basis for the self-monitoring of PTSD and SUD symptoms. Visits consists of self-report assessments, urine toxicology, and a brief check-in with staff to confirm general health and safety.
- PTSD Symptom Severity [ Time Frame: Six months ]
- Substance Use severity [ Time Frame: Six months ]
- Global psychiatric symptom severity [ Time Frame: Six months ]
- Treatment retention and compliance [ Time Frame: Six months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01365247
|United States, New York|
|City College of New York|
|New York, New York, United States, 10031|
|Principal Investigator:||Denise A. Hien, Ph.D.||City College of New York & New York State Psychiatric Institute/Columbia University|