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

NCT01365247 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2015-05-14

No results posted yet for this study

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).

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Medical University of South Carolina

    collaborator OTHER

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • The City College of New York

    lead OTHER

Principal Investigators

  • Denise A. Hien, Ph.D. · City College of New York & New York State Psychiatric Institute/Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01365247 on ClinicalTrials.gov