Tobacco Treatment as Augmentation for Cognitive Processing Therapy for PTSD

Stopped early · Not applicable

Conditions studied: Posttraumatic Stress Disorder, Tobacco Dependence

In brief

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.

Key facts

Study ID

NCT02012452

Run by

VA Office of Research and Development

People needed

19

Starts

2014-12-01

Expected to finish

2016-01-01

Last updated by the study team

2016-10-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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]

You may not qualify if…

• 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.

Where it is running

• VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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