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

May 13, 2015 updated by: Denise Hien, The City College of New York

A Randomized Trial of Concurrent Treatment for PTSD and Substance Dependence

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).

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10031
        • City College of New York

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PTSD Symptom Severity
Time Frame: Six months
Six months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The City College of New York

Collaborators

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

Investigators

  • Principal Investigator: Denise A. Hien, Ph.D., City College of New York & New York State Psychiatric Institute/Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

June 1, 2011

First Submitted That Met QC Criteria

June 2, 2011

First Posted (Estimate)

June 3, 2011

Study Record Updates

Last Update Posted (Estimate)

May 14, 2015

Last Update Submitted That Met QC Criteria

May 13, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01DA023187-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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