Back to results

Tobacco Treatment as Augmentation for Cognitive Processing Therapy for PTSD

Primary Purpose

Posttraumatic Stress Disorder, Tobacco Dependence

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Tobacco treatment

Health Education

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring posttraumatic stress disorder, tobacco dependence, cognitive behavioral therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

tobacco treatment

health education treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Clinician Administered PTSD Scale

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

Secondary Outcome Measures

Percent Abstinent From Tobacco Use

biochemically confirmed abstinence from tobacco using self-report, cotinine, and CO breath samples

Full Information

NCT ID

NCT02012452

First Posted

September 26, 2013

Last Updated

September 6, 2016

Sponsor

VA Office of Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT02012452

Brief Title

Tobacco Treatment as Augmentation for Cognitive Processing Therapy for PTSD

Official Title

Tobacco Treatment as Augmentation to Cognitive Processing Therapy for PTSD

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Terminated

Why Stopped

PI moving outside VA- grant not transferable

Study Start Date

December 2014 (undefined)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VA Office of Research and Development

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Posttraumatic Stress Disorder, Tobacco Dependence

Keywords

posttraumatic stress disorder, tobacco dependence, cognitive behavioral therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

tobacco treatment

Arm Type

Experimental

Arm Description

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

Arm Title

health education treatment

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Tobacco treatment

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Health Education

Intervention Description

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

Primary Outcome Measure Information:

Title

Clinician Administered PTSD Scale

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

Secondary Outcome Measure Information:

Title

Percent Abstinent From Tobacco Use

Description

biochemically confirmed abstinence from tobacco using self-report, cotinine, and CO breath samples

Time Frame

end of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sandra Japuntich, PhD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02130

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Tobacco Treatment as Augmentation for Cognitive Processing Therapy for PTSD

We'll reach out to this number within 24 hrs