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Tobacco Treatment as Augmentation for Cognitive Processing Therapy for PTSD

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ClinicalTrials.gov Identifier: NCT02012452
Recruitment Status : Terminated (PI moving outside VA- grant not transferable)
First Posted : December 16, 2013
Results First Posted : October 27, 2016
Last Update Posted : October 27, 2016
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Tobacco Dependence Behavioral: Tobacco treatment Behavioral: Health Education Not Applicable

Detailed Description:
The proposed research aims to examine the effect of tobacco on PTSD symptoms and PTSD recovery as well as the effect of PTSD recovery on tobacco use. This study has 3 aims: (1) to evaluate whether tobacco use interferes with recovery from PTSD during empirically based, trauma focused PTSD treatment. (2) To gather preliminary data about whether tobacco use alleviates PTSD symptoms among continued tobacco users vs. recent quitters. (3) To explore the impact of recovery from PTSD treatment on tobacco use quantity and frequency, tobacco withdrawal symptoms, and craving for tobacco. To test these aims, the investigators propose a randomized two group design where 75 participants are assigned to receive either tobacco treatment (Contingency Management plus Cognitive Behavioral Therapy) or control treatment (Health Education) before completing Cognitive Processing Therapy (CPT) for PTSD. Study outcome variables will be PTSD symptom severity following CPT, PTSD symptom severity during tobacco cessation treatment, and tobacco use and tobacco withdrawal during CPT.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tobacco Treatment as Augmentation to Cognitive Processing Therapy for PTSD
Study Start Date : December 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: tobacco treatment
participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment
 Behavioral: Tobacco treatment
participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment
Sham Comparator: health education treatment
Participants will be provided education on a variety of health topics and will set health goals around each topic
 Behavioral: Health Education
Participants will be provided education on a variety of health topics and will set health goals around each topic


Outcome Measures
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Primary Outcome Measures :
  1. Clinician Administered PTSD Scale [ Time Frame: end of 6 week PTSD treatment ]
    posttraumatic stress disorder clinician rated symptom ratings; scores range from 0-80 (with higher scores indicating greater PTSD severity)


Secondary Outcome Measures :
  1. Percent Abstinent From Tobacco Use [ Time Frame: end of treatment ]
    biochemically confirmed abstinence from tobacco using self-report, cotinine, and CO breath samples


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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]

Exclusion Criteria:

  • Exclusion criteria will include current participation in another research study, history of bipolar I disorder,
  • 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.
  • In addition, participants must agree to keep psychiatric medication doses stable for the duration of the study (except for dose adjustments for changes in medication blood levels due to tobacco cessation), unless there is a concern for participant safety.
Contacts and Locations
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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): NCT02012452


Locations
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United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Sandra Japuntich, PhD VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
More Information
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02012452    
Other Study ID Numbers: NURA-018-13S
1IK2CX000918-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 16, 2013    Key Record Dates
Results First Posted: October 27, 2016
Last Update Posted: October 27, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by VA Office of Research and Development:
posttraumatic stress disorder
tobacco dependence
cognitive behavioral therapy
Additional relevant MeSH terms:
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Tobacco Use Disorder
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
 Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders