Concurrent Treatment for Substance Dependent Individuals With Post-Traumatic Stress Disorder (PTSD)

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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A Randomized Trial of Concurrent Treatment for PTSD and Substance Dependence

Conditions
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Stress Disorders, Post-Traumatic, Substance-Related Disorders

Intervention / Treatment
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* Behavioral: Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure
* Behavioral: Relapse Prevention Treatment
* Behavioral: Active Monitoring Control Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women who are a minimum of 18 years and maximum of 65 years. Participants meet DSM-IV criteria for current or past substance dependence Participants must have used alcohol or other drugs within the past 3 months Participants must speak English Participants must meet DSM-IV criteria for current PTSD in response to on an interpersonal, civilian trauma Participants are capable of giving informed consent and capable of complying with study procedures. Participants demonstrate no gross organic mental syndrome Exclusion Criteria: Participants who are currently suicidal or homicidal Participants who carry a diagnosis of BiPolar I or psychotic disorders are exclusionary. Participants receiving PTSD-specific treatment Participants on anxiolytic, antidepressant or mood stabilizing medications which have been initiated during the 8 weeks prior to study participation Participants refusing to be audio or video taped

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COPE<br>Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure | Behavioral: Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure<br>* A manualized, twelve-week intervention applying cognitive-behavioral strategies and prolonged exposure (PE) techniques to address substance use and trauma related issues.<br>|
| Active Comparator: RPT<br>Relapse Prevention Therapy | Behavioral: Relapse Prevention Treatment<br>* Relapse Prevention Treatment is a cognitive-behavioral skills training approach to initiating and maintaining substance use-related goals.<br>|
| Active Comparator: Active Monitoring Control Group<br> | Behavioral: Active Monitoring Control Group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD Symptom Severity |  | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Substance Use severity |  | Six months | 
| Global psychiatric symptom severity |  | Six months | 
| Treatment retention and compliance |  | Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Co-morbid substance disorders and PTSD, Trauma, Alcohol and other drug use disorders, Treatment outcome, Post-Traumatic Stress Disorder (PTSD), Co-morbid Alcohol and other drug use disorders (AOD), Behavioral Treatment