NCT01365247

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

A Randomized Trial of Concurrent Treatment for PTSD and Substance Dependence

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: The City College of New York · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.
BEHAVIORAL	Relapse Prevention Treatment	Relapse Prevention Treatment is a cognitive-behavioral skills training approach to initiating and maintaining substance use-related goals.
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.

Timeline

• Start date: 2008-09-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2011-06-03
• Last updated: 2015-05-14

Locations

1 site across 1 country: United States