Tobacco Treatment as Augmentation for Cognitive Processing Therapy for PTSD

NCT ID: NCT02012452

Last Updated: 2016-10-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-01-31

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.

Conditions

Posttraumatic Stress Disorder; Tobacco Dependence

Keywords

posttraumatic stress disorder; tobacco dependence; cognitive behavioral therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tobacco treatment

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

Group Type: EXPERIMENTAL

Tobacco treatment

Intervention Type: BEHAVIORAL

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

health education treatment

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

Group Type: SHAM_COMPARATOR

Health Education

Intervention Type: BEHAVIORAL

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

Interventions

Tobacco treatment

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

Intervention Type: BEHAVIORAL

Health Education

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

Intervention Type: BEHAVIORAL

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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandra Japuntich, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

1IK2CX000918-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NURA-018-13S

Identifier Type: -

Identifier Source: org_study_id