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

• 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 ]

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 Dependence and Relapse Prevention Therapy] and a delayed treatment 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 a delayed treatment 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 Dependence (CTPSD); (2) Relapse Prevention Treatment (RPT) or a (3) Delayed Treatment Control Group (DTCG). 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.

• Stress Disorders, Post-Traumatic
• Substance-Related Disorders

• Behavioral: Concurrent Treatment of PTSD and Substance Dependence
  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 abstinence from various types of substance abuse

• Active Comparator: Concurrent Treatment of PTSD & Substance Dependence (CTPSD)
  A treatment that focuses on substance abuse and trauma related issues
  Intervention: Behavioral: Concurrent Treatment of PTSD and Substance Dependence
• Active Comparator: Relapse Prevention Treatment (RPT)
  A treatment that focuses on substance abuse alone
  Intervention: Behavioral: Relapse Prevention Treatment
• No Intervention: Delayed Treatment Control Group
  Twelve (12) week waitlist

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

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