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

This study has been completed.
Sponsor:
Collaborators:
Medical University of South Carolina
Information provided by (Responsible Party):
Denise Hien, The City College of New York
ClinicalTrials.gov Identifier:
NCT01365247
First received: June 1, 2011
Last updated: May 13, 2015
Last verified: May 2015
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Concurrent Treatment for PTSD and Substance Dependence

Resource links provided by NLM:


Further study details as provided by The City College of New York:

Primary Outcome Measures:
  • PTSD Symptom Severity [ Time Frame: Six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Substance Use severity [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Global psychiatric symptom severity [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Treatment retention and compliance [ Time Frame: Six months ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: September 2008
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01365247

Locations
United States, New York
City College of New York
New York, New York, United States, 10031
Sponsors and Collaborators
The City College of New York
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
  More Information

No publications provided

Responsible Party: Denise Hien, Professor, The City College of New York
ClinicalTrials.gov Identifier: NCT01365247     History of Changes
Other Study ID Numbers: 1R01DA023187-01A1, 1R01DA023187-01A1
Study First Received: June 1, 2011
Last Updated: May 13, 2015
Health Authority: United States: Federal Government

Keywords provided by The City College of New York:
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

Additional relevant MeSH terms:
Disease
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Substance-Related Disorders
Anxiety Disorders
Chemically-Induced Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2015