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Completed

NCT Number: NCT01365247

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

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).

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Key information

Conditions

Stress Disorders, Post-Traumatic Chemically-Induced Disorders Mental Disorders Stress Disorders, Traumatic Substance-Related Disorders Trauma and Stressor Related Disorders Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City College of New York

New York, 10031, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure

Behavioral

A manualized, twelve-week intervention applying cognitive-behavioral strategies and prolonged exposure (PE) techniques to address substance use and trauma related issues.

Relapse Prevention Treatment

Behavioral

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

Active Monitoring Control Group

Behavioral

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.

Primary outcomes

  1. PTSD Symptom Severity

    Time frame: Six months

Secondary outcomes

  1. Substance Use severity

    Time frame: Six months

  2. Global psychiatric symptom severity

    Time frame: Six months

  3. Treatment retention and compliance

    Time frame: Six months

Sponsors and collaborators

Lead sponsor

The City College of New York

Other

Collaborators

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

Registry information

Official study title

A Randomized Trial of Concurrent Treatment for PTSD and Substance Dependence

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Jun 3, 2011
Registry last updated
May 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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