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

Primary Purpose

Stress Disorders, Post-Traumatic, Substance-Related Disorders

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure

Relapse Prevention Treatment

Active Monitoring Control Group

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring Co-morbid substance disorders and PTSD, Trauma, Alcohol and other drug use disorders, Treatment outcome, Post-Traumatic Stress Disorder (PTSD), Co-morbid Alcohol and other drug use disorders (AOD), Behavioral Treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

City College of New York

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

COPE

RPT

Active Monitoring Control Group

Arm Description

Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure

Relapse Prevention Therapy

Outcomes

Primary Outcome Measures

PTSD Symptom Severity

Secondary Outcome Measures

Substance Use severity

Global psychiatric symptom severity

Treatment retention and compliance

Full Information

NCT ID

NCT01365247

First Posted

June 1, 2011

Last Updated

May 13, 2015

Sponsor

The City College of New York

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01365247

Brief Title

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

Official Title

A Randomized Trial of Concurrent Treatment for PTSD and Substance Dependence

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The City College of New York

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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).

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stress Disorders, Post-Traumatic, Substance-Related Disorders

Keywords

Co-morbid substance disorders and PTSD, Trauma, Alcohol and other drug use disorders, Treatment outcome, Post-Traumatic Stress Disorder (PTSD), Co-morbid Alcohol and other drug use disorders (AOD), Behavioral Treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

110 (Actual)

8. Arms, Groups, and Interventions

Arm Title

COPE

Arm Type

Experimental

Arm Description

Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure

Arm Title

RPT

Arm Type

Active Comparator

Arm Description

Relapse Prevention Therapy

Arm Title

Active Monitoring Control Group

Arm Type

Active Comparator

Intervention Type

Behavioral

Intervention Name(s)

Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Relapse Prevention Treatment

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Active Monitoring Control Group

Intervention Description

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 Outcome Measure Information:

Title

PTSD Symptom Severity

Time Frame

Six months

Secondary Outcome Measure Information:

Title

Substance Use severity

Time Frame

Six months

Title

Global psychiatric symptom severity

Time Frame

Six months

Title

Treatment retention and compliance

Time Frame

Six months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Denise A. Hien, Ph.D.

Organizational Affiliation

City College of New York & New York State Psychiatric Institute/Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

City College of New York

City

New York

State/Province

New York

ZIP/Postal Code

10031

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

28541802

Citation

Flanagan JC, Fischer MS, Badour CL, Ornan G, Killeen TK, Back SE. The Role of Relationship Adjustment in an Integrated Individual Treatment for PTSD and Substance Use Disorders Among Veterans: An Exploratory Study. J Dual Diagn. 2017 Jul-Sep;13(3):213-218. doi: 10.1080/15504263.2017.1312039. Epub 2017 May 25.

Results Reference

derived

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

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