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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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Posttraumatic Stress Disorder
Tobacco Dependence
Interventions Behavioral: Tobacco treatment
Behavioral: Health Education
Enrollment 19
Recruitment Details 19 participants came in for an in-person screening visit. Of those, 9 met inclusion criteria.
Pre-assignment Details  
Arm/Group Title Tobacco Treatment Health Education Treatment
Hide Arm/Group Description

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

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

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

Period Title: Overall Study
Started 7 2
Completed 1 1
Not Completed 6 1
Reason Not Completed
Lost to Follow-up             2             1
Withdrawal by Subject             4             0
Arm/Group Title Tobacco Treatment Health Education Treatment Total
Hide Arm/Group Description

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

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

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

Total of all reporting groups
Overall Number of Baseline Participants 7 2 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 2 participants 9 participants
57.35  (7.24) 57.05  (9.66) 57.12  (8.75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 2 participants 9 participants
Female
1
  14.3%
0
   0.0%
1
  11.1%
Male
6
  85.7%
2
 100.0%
8
  88.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 2 participants 9 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  14.3%
1
  50.0%
2
  22.2%
White
6
  85.7%
1
  50.0%
7
  77.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 2 participants 9 participants
7 2 9
Clinical Administered PTSD scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 7 participants 2 participants 9 participants
40.86  (14.51) 50.0  (8.49) 42.89  (13.53)
[1]
Measure Description: Scores range from 0-80. Higher scores indicate greater PTSD severity.
1.Primary Outcome
Title Clinician Administered PTSD Scale
Hide Description posttraumatic stress disorder clinician rated symptom ratings; scores range from 0-80 (with higher scores indicating greater PTSD severity)
Time Frame end of 6 week PTSD treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tobacco Treatment Health Education Treatment
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 2 1
Mean (Standard Deviation)
Unit of Measure: units on a scale
18.67  (8.33) 12  (0)
2.Secondary Outcome
Title Percent Abstinent From Tobacco Use
Hide Description biochemically confirmed abstinence from tobacco using self-report, cotinine, and CO breath samples
Time Frame end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
If participants did not come the follow-up visit they were assumed to be smokers. If they attended a later follow-up visit, tobacco use was retroactively assessed.
Arm/Group Title Tobacco Treatment Health Education Treatment
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 7 2
Measure Type: Number
Unit of Measure: percent abstinent
14.3 0
Time Frame 25 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tobacco Treatment Health Education Treatment
Hide Arm/Group Description

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

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

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

All-Cause Mortality
Tobacco Treatment Health Education Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Tobacco Treatment Health Education Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      1/2 (50.00%)    
Gastrointestinal disorders     
hospitalization * [1]  0/7 (0.00%)  0 1/2 (50.00%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Participant went to the ER for chest pain but it was diagnosed as reflux
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tobacco Treatment Health Education Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/7 (14.29%)      0/2 (0.00%)    
Psychiatric disorders     
psychosis * [1]  1/7 (14.29%)  1 0/2 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
participant was reporting some delusions (e.g., that the therapist could tell the government to change the laws because the VA is part of the government) the participant later tested positive for cocaine at this visit.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Sandra Japuntich
Organization: VA Boston healthcare system
Phone: 6082398018
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02012452     History of Changes
Other Study ID Numbers: NURA-018-13S
1IK2CX000918-01A1 ( U.S. NIH Grant/Contract )
First Submitted: September 26, 2013
First Posted: December 16, 2013
Results First Submitted: January 28, 2016
Results First Posted: October 27, 2016
Last Update Posted: October 27, 2016