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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA023187-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Medical University of South Carolina | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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This treatment intervention trial is designed for men and women with substance dependence and comorbid Post-Traumatic Stress Disorder (PTSD). Participants will be randomly assigned to one of three conditions (two behavioral treatments [Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure and Relapse Prevention Therapy] and an active monitoring control group) and will be evaluated at baseline and four follow-up points (post-treatment, 1-month, 2- month and 3-month post-treatment).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COPE | Experimental | Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure |
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| RPT | Active Comparator | Relapse Prevention Therapy |
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| Active Monitoring Control Group | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure | Behavioral | A manualized, twelve-week intervention applying cognitive-behavioral strategies and prolonged exposure (PE) techniques to address substance use and trauma related issues. |
| Measure | Description | Time Frame |
|---|---|---|
| PTSD Symptom Severity | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| Substance Use severity | Six months | |
| Global psychiatric symptom severity | Six months | |
| Treatment retention and compliance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Denise A. Hien, Ph.D. | City College of New York & New York State Psychiatric Institute/Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City College of New York | New York | New York | 10031 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28541802 | Derived | 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. |
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| Relapse Prevention Treatment | Behavioral | Relapse Prevention Treatment is a cognitive-behavioral skills training approach to initiating and maintaining substance use-related goals. |
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| Active Monitoring Control Group | Behavioral | 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. |
|
| Six months |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D019966 | Substance-Related Disorders |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D064419 | Chemically-Induced Disorders |
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