- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02012452
Tobacco Treatment as Augmentation for Cognitive Processing Therapy for PTSD
September 6, 2016 updated by: VA Office of Research and Development
Tobacco Treatment as Augmentation to Cognitive Processing Therapy for PTSD
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02130
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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
|
Participants will be provided education on a variety of health topics and will set health goals around each topic
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
end of 6 week PTSD treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Abstinent From Tobacco Use
Time Frame: end of treatment
|
biochemically confirmed abstinence from tobacco using self-report, cotinine, and CO breath samples
|
end of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sandra Japuntich, PhD, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2014
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
September 26, 2013
First Submitted That Met QC Criteria
December 9, 2013
First Posted (Estimate)
December 16, 2013
Study Record Updates
Last Update Posted (Estimate)
October 27, 2016
Last Update Submitted That Met QC Criteria
September 6, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NURA-018-13S
- 1IK2CX000918-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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