NCT01365247

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 14, 2015

Status Verified

May 1, 2015

Enrollment Period

6.3 years

First QC Date

June 1, 2011

Last Update Submit

May 13, 2015

Conditions

Stress Disorders, Post-TraumaticSubstance-Related Disorders

Keywords

Co-morbid substance disorders and PTSDTraumaAlcohol and other drug use disordersTreatment outcomePost-Traumatic Stress Disorder (PTSD)Co-morbid Alcohol and other drug use disorders (AOD)Behavioral Treatment

Outcome Measures

Primary Outcomes (1)

  • PTSD Symptom Severity

    Six months

Secondary Outcomes (3)

  • Substance Use severity

    Six months

  • Global psychiatric symptom severity

    Six months

  • Treatment retention and compliance

    Six months

Study Arms (3)

COPE

EXPERIMENTAL

Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure

Behavioral: Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure

RPT

ACTIVE COMPARATOR

Relapse Prevention Therapy

Behavioral: Relapse Prevention Treatment

Active Monitoring Control Group

ACTIVE COMPARATOR
Behavioral: Active Monitoring Control Group

Interventions

Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged ExposureBEHAVIORAL

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

COPE
Relapse Prevention TreatmentBEHAVIORAL

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

RPT
Active Monitoring Control GroupBEHAVIORAL

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.

Active Monitoring Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Participants who are currently suicidal or homicidal
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City College of New York

New York, New York, 10031, United States

Location

Related Publications (1)

  • 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.

    PMID: 28541802DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticSubstance-Related DisordersWounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersChemically-Induced Disorders

Study Officials

  • Denise A. Hien, Ph.D.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 1, 2011

First Posted

June 3, 2011

Study Start

September 1, 2008

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

May 14, 2015

Record last verified: 2015-05

Locations

US(1)