Study on Sit to Quit Phone Intervention

This study is designed to test the effectiveness of the smoking cessation intervention "Sit
to Quit" through a randomized-control trial. This study will compare abstinence outcomes in
the Sit to Quit study group to a control group using the North Carolina State Tobacco Quit
Line. This is an investigational study (n=60) designed to test Sit to Quit (STQ) versus Quit
Line (QL) through a pilot randomized control trial. The proposed study is designed with
double-blind procedures (participants and study staff) for randomization of 60 participants
recruited through Duke Smoking Cessation Program into two groups: STQ and QL. STQ
participants will receive access to the STQ Instructional Video, the STQ manual, and
proactive Quit Coach calls supporting STQ. QL participants will be instructed to contact the
NC Quit Line and will receive access to "web Coach" (Alere Well-being site), the Quit Line
manual, and proactive Quit Coach calls supporting "Quit for Life." All statistical analysis
will be performed under the directions of the statistician designated in key personnel.
Outcomes of variables including: demographic variables, evaluation responses, and abstinence
rates will be analyzed using general regression models using an ANOVA-based design. The study
Principal Investigator Dr. James Davis will ultimately be responsible for data and safety
monitoring. Subject data will be collected during visits and captured in the Electronic
Medical Record. Data will be collected by phone, and this data will be stored in REDCap.
Participants that experience events related to their clinical treatment will be recommended
to follow-up with their provider.

Inclusion Criteria:

- Patient being treated at Duke Smoking Cessation Program for tobacco use

- Age 18 years or older

- Actively smoking 5 or more cigarettes per day for at least one year

- Fluency in spoken and written English

- Willing to set a quit date within 2 weeks

- Access to a smart phone or internet and telephone

- Willingness to watch 3 videos on computer, receive 5 counseling calls, and attend
investigational visits.

Exclusion Criteria:

- CO test under 7 ppm during initial screening

- 8 or above on the Alcohol Use Disorders Identification Test (AUDIT-10)

- 6 or above on Drug Abuse Screening Test (DAST-10)

- 3 or above on Patient Health Questionnaire (PHQ-2) Depression Scale

- Daily use of a second form of tobacco or nicotine (e.g. e-cigarettes, cigars, chewing
tobacco, snuff)

- Current use of a smoking cessation medication (e.g. nicotine replacement, Varenicline,
Bupropion)

- Intolerable side effects related to, refusal to take, or medical contraindication with
nicotine patch

- Symptomatic cognitive or emotive disorder such as untreated schizophrenia, severe
untreated depression, or severe untreated anxiety. This is determined by clinical
assessment.