Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Collaborators:
Medical University of South Carolina
National Institute on Drug Abuse (NIDA)
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

June 1, 2011
May 13, 2015
September 2008
December 2014   (final data collection date for primary outcome measure)
PTSD Symptom Severity [ Time Frame: Six months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01365247 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Concurrent Treatment for Substance Dependent Individuals With Post-Traumatic Stress Disorder (PTSD)
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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Stress Disorders, Post-Traumatic
  • Substance-Related Disorders
  • 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.
  • Experimental: COPE
    Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure
    Intervention: Behavioral: Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure
  • Active Comparator: RPT
    Relapse Prevention Therapy
    Intervention: Behavioral: Relapse Prevention Treatment
  • Active Comparator: Active Monitoring Control Group
    Intervention: Behavioral: Active Monitoring Control Group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01365247
1R01DA023187-01A1, 1R01DA023187-01A1
Yes
Not Provided
Not Provided
Denise Hien, The City College of New York
The City College of New York
  • Medical University of South Carolina
  • National Institute on Drug Abuse (NIDA)
Principal Investigator: Denise A. Hien, Ph.D. City College of New York & New York State Psychiatric Institute/Columbia University
The City College of New York
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP