Study Two on the Effectiveness of Mindfulness Training for Smokers

The MTS2 Study is funded for through a five-year K23 NIH training grant (appendix) awarded to
Dr. James Davis, the Principal Investigator on this protocol. The study enrollment goal is
N=240 adult smokers randomized to study treatments. Based on prior recruitment numbers, it is
expected that roughly 50% (120) will choose to be in an intensive intervention and 50% (120)
will choose to be in the non-intensive intervention. Participants who choose to be in an
intensive intervention will be randomized to either MTS (n = 60) or ITS (n=60). MTS is a
smoking cessation intervention that provides 8 mindfulness classes over a 6-week period. ITS
will provide participants will access to the Freedom From Smoking Online Premium Program (at
no cost) plus 8 smoking cessation classes over a 6-week period. Participants who choose to be
in a non-intensive intervention (n=120) will receive a phone-based intervention through the
Wisconsin Tobacco Quit Line. At the Orientation Meeting, participants who decide to enter the
study will be allowed to choose whether they enter an intensive or the non-intensive
intervention. Intensive intervention participants will attend an additional meeting called
the Introductory Meeting where they are will undergo randomization into either the MTS or
ITS. The Introductory Meeting will also provide instruction on the use of nicotine patches,
smoking calendars and provide intervention materials. The study employs 3 study assessment
visits. Study Visit 1 follows the Orientation Meeting, Study Visit 2 is 4-weeks post-quit,
Study Visit 3 is 24-weeks post-quit. All participants will receive 2 weeks of free nicotine
patches and $30 for attending each of the two post-quit study visits.

The total time for the study including recruitment, intervention and participant follow-up
for N = 240 will be three years. The study will recruit subjects from the Dane county region
through the University of Wisconsin School of Medicine and Public Health Center for Tobacco
Research and Intervention (UW-CRTI). Recruitment will take place through flyers, television,
newspaper and radio advertisements.

The principal hypothesis for the study is that MTS compared to ITS will show significantly
higher point prevalent Carbon Monoxide confirmed smoking abstinence rates at 4 and 24 weeks
post quit. Secondary hypotheses is that study group compared to controls will show
significant differences in questionnaire results that test distress, depression, anxiety,
attentional control, mindfulness and quality of life and bio-physiological markers such as
weight, breath holding and hair cortisol.

Inclusion Criteria:

- Age: 18 years or over;

- Participants must express "high" motivation to quit smoking

- Participants must express willingness to attend "all" meetings for 2 months

- Smoke 5 or more cigarettes per day

Exclusion Criteria:

- Self report of alcohol use of 4 drinks or more a night on 4 or more nights per week.

- Self report of using chewing tobacco, snuff or cigars in the last week.

- High score on Patient Health Questionnaire Depression Screening Tool for severe
depression and suicidal intention.