Tobacco Treatment as Augmentation for Cognitive Processing Therapy for PTSD

Posttraumatic Stress Disorder Clinical Trial

Official title:

Tobacco Treatment as Augmentation to Cognitive Processing Therapy for PTSD

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02012452
• Other study ID #: NURA-018-13S
• Secondary ID: 1IK2CX000918-01A
• Status: Terminated
• Phase: N/A
• First received: September 26, 2013
• Last updated: January 21, 2016
• Start date: December 2014
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Tobacco Dependence
• Tobacco Use Disorder

Intervention

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

Locations

Country	Name	City	State
United States	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Administered PTSD Scale	posttraumatic stress disorder clinician rated symptom ratings	end of 6 week PTSD treatment	No
Secondary	tobacco use	biochemically confirmed tobacco use using self-report, cotinine, and CO breath samples	end of treatment	No