Clinical trial NCT02461732: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Substance Dependence
Keywords: posttraumatic stress disorder
PTSD
substance dependence
substance use
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2015-06-03
Enrollment: 60
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: 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.

Eligibility 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

Primary outcomes:
measure: PTSD Symptoms
timeFrame: for the duration of the study / through the conclusion of treatment, up to 8 weeks
measure: Substance Use
timeFrame: for the duration of the study / through the conclusion of treatment, up to 8 weeks
measure: PTSD Diagnosis
timeFrame: for the duration of the study / through the conclusion of treatment, up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston - Center for Neurobehavioral Research on Addiction
state: Texas
Study officials:
References: