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

Substance-Related Disorders Clinical Trial

Official title:

A Randomized Trial of Concurrent Treatment for PTSD and Substance Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01365247
• Other study ID #: 1R01DA023187-01A1
• Secondary ID: 1R01DA023187-01A
• Status: Completed
• Phase: N/A
• First received: June 1, 2011
• Last updated: May 13, 2015
• Start date: September 2008
• Est. completion date: December 2014

Study information

• Verified date: May 2015
• Source: The City College of New York
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	City College of New York	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
The City College of New York	Medical University of South Carolina, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD Symptom Severity		Six months	No
Secondary	Substance Use severity		Six months	No
Secondary	Global psychiatric symptom severity		Six months	No
Secondary	Treatment retention and compliance		Six months	No