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History of Changes for Study: NCT02461732
Trial of a Novel Cognitive-Behavioral Treatment for Posttraumatic Stress and Substance Dependence
Latest version (submitted May 9, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 2, 2015 None (earliest Version on record)
2 May 3, 2016 Study Status
3 May 9, 2017 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT02461732
Submitted Date:  June 2, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: HSC-MS-14-0486
Brief Title: Trial of a Novel Cognitive-Behavioral Treatment for Posttraumatic Stress and Substance Dependence
Official Title: Randomized Controlled Trial of a Novel Cognitive-Behavioral Treatment for Posttraumatic Stress and Substance Dependence
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2015
Overall Status: Recruiting
Study Start: August 2014
Primary Completion: May 2016 [Anticipated]
Study Completion: December 2016 [Anticipated]
First Submitted: May 22, 2015
First Submitted that
Met QC Criteria:
June 2, 2015
First Posted: June 3, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 2, 2015
Last Update Posted: June 3, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: The University of Texas Health Science Center, Houston
Responsible Party: Principal Investigator
Investigator: Anka A Vujanovic
Official Title: Assistant Professor
Affiliation: The University of Texas Health Science Center, Houston
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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.

Open or close this module Conditions
Conditions: Posttraumatic Stress Disorder
Substance Dependence
Keywords: posttraumatic stress disorder
PTSD
substance dependence
substance use
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 100 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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

Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Jessica Vincent, B.S.
Telephone: 713-486-2645
Email: Jessica.N.Vincent@uth.tmc.edu
Central Contact Backup: Rolanda Johnson, M.A.
Telephone: 713-486-2823
Email: Rolanda.Johnson@uth.tmc.edu
Locations: United States, Texas
University of Texas Health Science Center at Houston - Center for Neurobehavioral Research on Addiction
[Recruiting]
Houston, Texas, United States, 77054
Contact:Contact: Rolanda Johnson, M.A. 713-486-2823 Rolanda.Johnson@uth.tmc.edu
Contact:Contact: Jessica Vincent, B.S. 713-486-2645 Jessica.N.Vincent@uth.tmc.edu
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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