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

Not Applicable

Completed

• Conditions: Substance-Related Disorders; Stress Disorders, Post-Traumatic
• Interventions: Behavioral: Relapse Prevention Treatment; Behavioral: Active Monitoring Control Group; Behavioral: Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure

• Registration Number: NCT01365247
• Lead Sponsor: The City College of New York

Brief Summary

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

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 Timeline

• Study Start: 2008-09
• Study First Submitted: 2011-06-01
• Study First Submitted QC: 2011-06-02
• Study First Posted: 2011-06-03
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-13
• Last Update Posted: 2015-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. Men and women who are a minimum of 18 years and maximum of 65 years.
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

1. Participants who are currently suicidal or homicidal
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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RPT	Relapse Prevention Treatment	Relapse Prevention Therapy
Active Monitoring Control Group	Active Monitoring Control Group	-
COPE	Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure	Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure

Primary Outcome Measures

Name	Time	Method
PTSD Symptom Severity	Six months

Secondary Outcome Measures

Name	Time	Method
Substance Use severity	Six months
Global psychiatric symptom severity	Six months
Treatment retention and compliance	Six months

Trial Locations

Locations (1)

City College of New York; 🇺🇸 New York, New York, United States