Clinical trial NCT01365247: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: The City College of New York
Sponsor class: OTHER
Collaborators: name: Medical University of South Carolina
name: National Institute on Drug Abuse (NIDA)
First posted: 2011-06-03
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: PTSD Symptom Severity
timeFrame: Six months
Secondary outcomes:
measure: Substance Use severity
timeFrame: Six months
measure: Global psychiatric symptom severity
timeFrame: Six months
measure: Treatment retention and compliance
timeFrame: Six months
Other outcomes:
Locations:
city: New York
country: United States
facility: City College of New York
state: New York
Study officials:
affiliation: City College of New York & New York State Psychiatric Institute/Columbia University
name: Denise A. Hien, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.