Tobacco Treatment as Augmentation for Cognitive Processing Therapy for PTSD

NCT02012452 | Terminated Results DMC

• 2 other identifiers: NURA-018-13S1IK2CX000918-01A1
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine whether tobacco affects recovery from PTSD. There are 3 goals of the study; (1) to test if quitting tobacco prior to PTSD treatment affects treatment success, (2) to test how PTSD symptoms change in those who have quit tobacco compared to those who continue to use and (3) to explore how tobacco use and tobacco withdrawal symptoms change during PTSD treatment.

Conditions

Posttraumatic Stress Disorder; Tobacco Dependence

Keywords

posttraumatic stress disorder; tobacco dependence; cognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

• Clinician Administered PTSD Scale

  posttraumatic stress disorder clinician rated symptom ratings; scores range from 0-80 (with higher scores indicating greater PTSD severity)

  end of 6 week PTSD treatment

Secondary Outcomes (1)

• Percent Abstinent From Tobacco Use

  end of treatment

Study Arms (2)

tobacco treatment

EXPERIMENTAL

participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment

Behavioral: Tobacco treatment

health education treatment

SHAM COMPARATOR

Participants will be provided education on a variety of health topics and will set health goals around each topic

Behavioral: Health Education

Interventions

Tobacco treatment BEHAVIORAL

participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment

tobacco treatment

Health Education BEHAVIORAL

Participants will be provided education on a variety of health topics and will set health goals around each topic

health education treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• current tobacco use (a urine cotinine level 200ng/ml),
• motivation to quit (measured by the 7 on the Biener Contemplation ladder)
• and a current diagnosis of PTSD \[as diagnosed by the Clinician Administered PTSD Scale for DSM-5\]

You may not qualify if:

• schizophreniform disorders except for psychosis NOS due to presence of trauma-related sensory hallucinations,
• cognitive impairment (\<25 of the Mini Mental State Exam),
• current suicidality/homicidality requiring clinical intervention or a suicide attempt in the past year,
• inability to provide reliable study data (e.g., provide an adulterated urine sample,
• provide misinformation to study staff including stating differing information to two or more staff members,
• attempt to misrepresent self in order to avoid being excluded from the study,
• inability to answer study questions which are used to determine eligibility),
• current non-tobacco substance use disorder (abuse or dependence or a positive drug screen; participants who have been abstinent for greater than 3 months will be allowed to participate),
• participation within the past 6 months in trauma-focused therapy (e.g., Prolonged Exposure, Cognitive Processing Therapy),
• current use of tobacco cessation pharmacotherapy (i.e., nicotine replacement therapy or varenicline),
• current use of benzodiazepines
• serious or uncontrolled medical condition precluding unaided tobacco cessation attempts,
• pregnancy,
• a recent change in psychiatric medications (change occurred \<2 months prior to entering the study),
• current participation in another research study.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Results Point of Contact

• Title: Sandra Japuntich
• Organization: VA Boston healthcare system

sjjapuntich@gmail.com

6082398018

Study Officials

• Sandra Japuntich, PhD

  VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2013
• First Posted: December 16, 2013
• Study Start: December 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: October 27, 2016
• Results First Posted: October 27, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)