Neural and Physiologic Correlates of Mental Stress and Cigarette Craving in Patients at Risk for Heart Disease

Condition(s) targeted: Smoking

Intervention: Standard Cognitive Therapy (Behavioral); Mindfulness Based Cognitive Therapy (Behavioral)

Phase: N/A

Status: Not yet recruiting

Sponsored by: University of Pittsburgh

Official(s) and/or principal investigator(s):
Hilary Tindle, MD, Principal Investigator, Affiliation: University of Pittsburgh

Overall contact:
Hilary Tindle, MD, Phone: 412 246 6929, Email: tindleha@upmc.edu

This project proposes to study coping in response to cigarette craving in 40 nicotine dependent adults ages 18-65 enrolled in a randomized trial of varenicline (tradename Chantix, a partial agonist of the alpha 4, beta 2 nicotinic acetylcholine receptor (nAChR) and effective medication for smoking cessation and prevention of relapse) and one of two 8-week cognitive behavioral therapies for smoking cessation: 1) standard cognitive therapy (CT) vs. 2) mindfulness based cognitive therapy (MBCT), a novel mind body therapy that extends basic CT principles to include the practice of mindfulness, which fosters a dispassionate approach to the experience of craving. Because mindfulness is fundamentally different from traditional cognitive strategies, it is expected that CT and MBCT will lead to differences in cue-induced craving that are reflected in differential neural activation patterns during applied coping.

Official title: Neural and Physiologic Correlates of Mental Stress and Cigarette Craving in Patients at Risk for Heart Disease

Study design: Treatment, Randomized, Open Label, Parallel Assignment

Primary outcome: Smoking Cessation

Secondary outcome:

Exhaled CO readings

Saliva Test

Functional Magnetic Resonance Imaging

Urine Pregnancy Test

Chantix medication

DNA testing

Self Reported Measures

Standard Cognitive Therapy

Mindfulness Based Cognitive Therapy

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Participants will be considered eligible for enrollment if they are between 18-65

years old, smoke at least ½ pack cigarettes per day, desire to quit smoking (self-reported 75+ out of a possible 100), and have no contraindications for varenicline medication therapy or fMRI scanning (such as body weight over 250 lbs, intravascular metal devices including stents, or claustrophobia).

Exclusion Criteria:

- Participants will not be considered eligible for enrollment if they are not between

18-65 years old, smoke less than ½ pack cigarettes per day, do not desire to quit

smoking (self-reported - 75 out of a possible 100), or have contraindications for

varenicline medication therapy or fMRI scanning (such as body weight over 250 lbs, intravascular metal devices including stents, or claustrophobia).

Hilary Tindle, MD, Phone: 412 246 6929, Email: tindleha@upmc.edu

University of Pittsburgh, Pittsburgh, Pennsylvania 15213, United States

Starting date: January 2009
Ending date: January 2011
Last updated: October 2, 2008