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Trial of a Novel Cognitive-Behavioral Treatment for Posttraumatic Stress and Substance Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02461732
Recruitment Status : Completed
First Posted : June 3, 2015
Last Update Posted : May 10, 2017
Sponsor:
Information provided by (Responsible Party):
Anka A Vujanovic, The University of Texas Health Science Center, Houston

Tracking Information
First Submitted Date  ICMJE May 22, 2015
First Posted Date  ICMJE June 3, 2015
Last Update Posted Date May 10, 2017
Study Start Date  ICMJE August 2014
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2015)
  • PTSD Symptoms [ Time Frame: for the duration of the study / through the conclusion of treatment, up to 8 weeks ]
    PCL-5 self-report measure: severity of symptoms
  • Substance Use [ Time Frame: for the duration of the study / through the conclusion of treatment, up to 8 weeks ]
    (1) rates of substance abstinence, as measured via urine toxicology testing, alcohol breath level analyses, and participants' self-reports of substance use; (2) longest sustained abstinence, defined as the maximum number of self-reported days of abstinence for each participant.
  • PTSD Diagnosis [ Time Frame: for the duration of the study / through the conclusion of treatment, up to 8 weeks ]
    CAPS interview measure: severity of symptoms
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of a Novel Cognitive-Behavioral Treatment for Posttraumatic Stress and Substance Dependence
Official Title  ICMJE Randomized Controlled Trial of a Novel Cognitive-Behavioral Treatment for Posttraumatic Stress and Substance Dependence
Brief Summary The purpose of the study is to determine whether a novel integrated cognitive-behavioral treatment for posttraumatic stress disorder (PTSD) and substance dependence (i.e., Treatment for Integrated Posttraumatic Stress and Substance use; TIPSS) is more effective than cognitive-behavioral treatment for substance dependence alone with regard to PTSD symptoms and substance use quantity and frequency.
Detailed Description

The proposed study is a randomized controlled clinical trial, comparing the efficacy of two cognitive-behavioral therapy (CBT) interventions: standard CBT for substance dependence and a novel integrated CBT program for PTSD and substance dependence. The study will run for approximately 3 years. A total of 100 participants will be enrolled at a rate of 4 participants per month over 25 months to ensure that 80 participants complete the protocol (presuming 20% attrition). Each participant will attend 12 treatment sessions, meeting twice per week for 6 weeks. Treatment sessions will last 1-hour each.

Primary study outcomes will include frequency and quantity of substance use and PTSD symptom severity. Substance use-related outcomes will include: rates of substance abstinence, as measured by (1) urine toxicology testing, (2) alcohol breath level analyses, and (3) participants' self-report of substance use. PTSD symptom outcomes will include symptom severity ratings as measured by clinical interview (i.e., Clinician-Administered PTSD Scale-5; CAPS-5) and self-report (Posttraumatic Checklist; PCL-5).

Secondary study outcomes will include examination of mediational effects. Specifically, changes in distress tolerance, as indexed via self-report (Distress Tolerance Scale) and computer/behavioral tasks (i.e., Mirror-Tracing Task, Paced Auditory Serial Addition Task-Computerized Version, Breath-Holding Task), are expected during the course of the treatment. Changes in cue reactivity are also expected over the course of treatment, as indexed by decreased psychophysiological reactivity (heart rate, respiration rate) during script-driven imagery tasks (listening to trauma/drug related scripts vs. netural). A total of four sessions (baseline/screening and sessions 4, 8, 12) will be preceded by the laboratory sessions.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Posttraumatic Stress Disorder
  • Substance Dependence
Intervention  ICMJE
  • Behavioral: Treatment for Integrated Posttraumatic Stress and Substance Use (TIPSS)

    Topics covered include:

    drug triggers; antecedents/consequences of drug use; relapse prevention; coping skills; problem thinking; changing problem thinking; lifestyle balance; values; increasing non-drug activities; education on PTSD and trauma/PTSD/substance use associations; discussion and written statement of impact of trauma on beliefs about self, others, world; written account of trauma memory and in-session review and discussion; cognitive exercises and cognitive restructuring regarding trauma-related thoughts; review of any between-session trauma-relevant substance use and cravings

  • Behavioral: Cognitive-Behavioral Therapy for Substance Dependence

    Topics covered include:

    drug triggers; antecedents/consequences of drug use; relapse prevention; coping skills; problem thinking; changing problem thinking; lifestyle balance; values; increasing non-drug activities

Study Arms  ICMJE
  • Active Comparator: CBT for Substance Dependence
    Standard CBT for substance use disorders
    Intervention: Behavioral: Cognitive-Behavioral Therapy for Substance Dependence
  • Experimental: Integrated CBT for PTSD and Substance Dependence
    Integrated CBT for PTSD and substance use disorders, combining elements of cognitive processing therapy for PTSD with coping skills and relapse prevention for substance use disorders
    Intervention: Behavioral: Treatment for Integrated Posttraumatic Stress and Substance Use (TIPSS)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2017)
60
Original Estimated Enrollment  ICMJE
 (submitted: June 2, 2015)
100
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18-65
  • English language proficiency
  • Current (past month) substance dependence, noting exclusions as delineated below
  • History of trauma exposure, as per DSM-5 Criterion A1 definition
  • Current (past month) PTSD symptoms: score of at least 25 on PCL-5 and/or at least 4 symptoms of moderate severity (scored 2 or higher) endorsed on CAPS-5
  • Seeking treatment for trauma-related symptoms and substance dependence

Exclusion Criteria:

  • Exclusive [only] nicotine dependence
  • Alcohol dependence requiring detoxification
  • Opiate dependence requiring detoxification
  • Current or past bipolar I disorder
  • Current or past major psychotic disorder
  • Active (past 6 months) psychotic spectrum symptoms
  • Major unstable medical conditions
  • Current (past month) suicidal ideation with intent and/or plan
  • Current (past month) homicidal ideation with intent and/or plan
  • Inability to provide verbal/written consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02461732
Other Study ID Numbers  ICMJE HSC-MS-14-0486
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Anka A Vujanovic, The University of Texas Health Science Center, Houston
Original Responsible Party Same as current
Current Study Sponsor  ICMJE The University of Texas Health Science Center, Houston
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The University of Texas Health Science Center, Houston
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP