Concurrent Treatment for Substance Dependent Individuals With Post-Traumatic Stress Disorder (PTSD)
NCT ID: NCT01365247
Last Updated: 2015-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
110 participants
INTERVENTIONAL
2008-09-30
2014-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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COPE
Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure
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.
RPT
Relapse Prevention Therapy
Relapse Prevention Treatment
Relapse Prevention Treatment is a cognitive-behavioral skills training approach to initiating and maintaining substance use-related goals.
Active Monitoring Control Group
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.
Interventions
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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.
Relapse Prevention Treatment
Relapse Prevention Treatment is a cognitive-behavioral skills training approach to initiating and maintaining substance use-related goals.
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.
Eligibility Criteria
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Inclusion Criteria
2. Participants meet DSM-IV criteria for current or past substance dependence
3. Participants must have used alcohol or other drugs within the past 3 months
4. Participants must speak English
5. Participants must meet DSM-IV criteria for current PTSD in response to on an interpersonal, civilian trauma
6. Participants are capable of giving informed consent and capable of complying with study procedures.
7. Participants demonstrate no gross organic mental syndrome
Exclusion Criteria
2. Participants who carry a diagnosis of BiPolar I or psychotic disorders are exclusionary.
3. Participants receiving PTSD-specific treatment
4. Participants on anxiolytic, antidepressant or mood stabilizing medications which have been initiated during the 8 weeks prior to study participation
5. Participants refusing to be audio or video taped
18 Years
65 Years
ALL
No
Sponsors
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Medical University of South Carolina
OTHER
National Institute on Drug Abuse (NIDA)
NIH
The City College of New York
OTHER
Responsible Party
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Denise Hien
Professor
Principal Investigators
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Denise A. Hien, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
City College of New York & New York State Psychiatric Institute/Columbia University
Locations
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City College of New York
New York, New York, United States
Countries
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References
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Flanagan JC, Fischer MS, Badour CL, Ornan G, Killeen TK, Back SE. The Role of Relationship Adjustment in an Integrated Individual Treatment for PTSD and Substance Use Disorders Among Veterans: An Exploratory Study. J Dual Diagn. 2017 Jul-Sep;13(3):213-218. doi: 10.1080/15504263.2017.1312039. Epub 2017 May 25.
Other Identifiers
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