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

Sponsor

The City College of New York (Other)

Overall Status

Completed

CT.gov ID

NCT01365247

Collaborator

Medical University of South Carolina (Other), National Institute on Drug Abuse (NIDA) (NIH)

110

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Stress Disorders, Post-Traumatic Substance-Related Disorders	Behavioral: Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure Behavioral: Relapse Prevention Treatment Behavioral: Active Monitoring Control Group	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized Trial of Concurrent Treatment for PTSD and Substance Dependence

Study Start Date :

Sep 1, 2008

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: COPE Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure	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.
Active Comparator: RPT Relapse Prevention Therapy	Behavioral: Relapse Prevention Treatment Relapse Prevention Treatment is a cognitive-behavioral skills training approach to initiating and maintaining substance use-related goals.
Active Comparator: Active Monitoring Control Group	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.

Arm

Intervention/Treatment

Experimental: COPE

Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure

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.

Active Comparator: RPT

Relapse Prevention Therapy

Behavioral: Relapse Prevention Treatment

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

Active Comparator: Active Monitoring Control Group

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.

Outcome Measures

Primary Outcome Measures

PTSD Symptom Severity [Six months]

Secondary Outcome Measures

Substance Use severity [Six months]
Global psychiatric symptom severity [Six months]
Treatment retention and compliance [Six months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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