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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

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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Substance Dependence Behavioral: Treatment for Integrated Posttraumatic Stress and Substance Use (TIPSS) Behavioral: Cognitive-Behavioral Therapy for Substance Dependence Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of a Novel Cognitive-Behavioral Treatment for Posttraumatic Stress and Substance Dependence
Study Start Date : August 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Arm Intervention/treatment
Active Comparator: CBT for Substance Dependence
Standard CBT for substance use disorders
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


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
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





Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02461732


Locations
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United States, Texas
University of Texas Health Science Center at Houston - Center for Neurobehavioral Research on Addiction
Houston, Texas, United States, 77054
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
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Responsible Party: Anka A Vujanovic, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02461732    
Other Study ID Numbers: HSC-MS-14-0486
First Posted: June 3, 2015    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: May 2017
Keywords provided by Anka A Vujanovic, The University of Texas Health Science Center, Houston:
posttraumatic stress disorder
PTSD
substance dependence
substance use
Additional relevant MeSH terms:
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Substance-Related Disorders
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Chemically-Induced Disorders