Trial Information

Treatment of Nicotine Dependence in a Health Care Setting

OBJECTIVES:

- Determine the effectiveness of varenicline with telephone counseling vs Internet-based
counseling vs telephone counseling and Internet-based smoking cessation interventions
in adult smokers.

- Determine individual or group differences in patients undergoing these interventions.

- Determine heterogeneity in responsiveness in regard to the Classification and
Regression Tree Analysis in patients undergoing these interventions.

- Determine the effectiveness of these interventions in regard to recruitment,
implementation, barriers to treatment, exposure to intervention, satisfaction with
treatment, treatment contamination, and program maintenance.

- Determine the cost-effectiveness of these interventions.

OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 3
intervention arms.

- Arm I: Patients undergo a proactive telephone-based (PTB) smoking cessation program.

- Arm II: Patients undergo a web-based (WB) smoking cessation program.

- Arm III: Patients undergo an integrated PTB/WB smoking cessation program. Beginning 1
week before the target quit date, all patients receive oral varenicline once daily for
3 days and then twice daily for up to 12 weeks. They also receive a mailed packet
containing a welcome letter, description of the intervention services offered, a
privacy notice, a Free & Clear Quit Kit (comprehensive education/self-help materials
including health smoking substitutions), a phone call to orient the patient to the
intervention to which they are randomized, and access to a toll-free support line. All
patients undergo a pre-treatment assessment (pre-quit) and 3 post-quit assessments at
21 days, 12 weeks, and 6 months after their original scheduled quit date to determine
medication adherence, treatment utilization, point-prevalent smoking outcomes, and
continuous nonsmoking.

PROJECTED ACCRUAL: A total of 1,200 patients will be accrued for this study.