PRIMARY OBJECTIVES:
I. To assess 30-day continuous biochemically confirmed abstinence at 12-weeks post-target quit day (TQD) in participants.
SECONDARY OBJECTIVES:
I. To assess 7-day point prevalence biochemically confirmed abstinence rates at 2- and 12-weeks post-TQD.
II. To assess phone-assessed self-reported 7-day point prevalence abstinence at 1-day, 1-week, 6-month, and 12-month post-TQD.
III. To assess smoking reduction (number of cigarettes per day) at 2 and 12 weeks post-TQD and on phone-based self-report at 1-day, 1-week, 6-month, and 12-month post-TQD.
IV. To compare biochemically confirmed 30-day continuous abstinence at 12-week post-TQD in participants who choose specific behavioral interventions (high intensity treatment [HIT] versus [vs.] moderate intensity treatment [MIT] vs. low intensity treatment [LIT]).
V. To compare biochemically confirmed 7-day abstinence at 2 and 12-week post-TQD in participants who choose HIT vs. MIT vs. LIT.
VI. To compare phone-assessed self-reported abstinence at 1-day, 1-week, 6-month, and 12-month post-TQD in participants who choose HIT vs. MIT vs. LIT.
VII. To compare smoking reduction (number of cigarettes per day) at 2 and 12 weeks post TQD and on phone-based self-report at 1-day, 1-week, and 6-month post-TQD in participants who choose HIT vs. MIT vs. LIT.
VIII. To compare smoking reduction (number of cigarettes per day) at baseline and 2 weeks post TQD in participants taking antihistamines or dextromethorphan.
IX. To assess baseline demographic variables (age, gender, race, education, and income) for an association with abstinence outcomes above.
X. To assess potential baseline (pre-treatment) predictors of abstinence including self-reported dependence, stress, anxiety, depression, alcohol and drug use, and self-efficacy.
XI. To assess change in self-reported measures at baseline (pre-quit) to 2 and 12-weeks post TQD on repeated standardized measures of stress, anxiety, and depression.
XII. To compare phone-assessed non-standardized single item questions on urges, withdrawal, stress, anxiety, depression, and self-efficacy at 1-day, 1-week, 6-month, and 12-month post-TQD.
XIII. To assess changes in quality of life measurements at baseline to 2- and 12-week post TQD on repeated quality of life measures in patients with HIT or MIT.
XIV. To assess changes in mindfulness in HIT vs. MIT groups at baseline to 2-week post TQD on repeated measures Five Facet Mindfulness Questionnaire (FFMQ).
XV. To assess amount of dextromethorphan/antihistamine taken to number of cigarettes smoked.
XVI. To conduct a cost-benefit analysis on clinic participation from the perspective of multiple stake holders: people who smoke, healthcare systems (clinics/hospitals), insurance companies, and employers.
XVII. To conduct a cost benefit analysis on participant choice of HIT vs. MIT vs. LIT from the perspective of multiple stake holders: people who smoke, healthcare systems (clinics/hospitals), insurance companies, and employers.
XVIII. To compare feasibility outcomes in use, attendance, completion of behavioral therapy, web usage in HIT, MIT, and LIT, medication use and compliance, medication side effects, referral routes to Duke Smoking Cessation Program (DSCP), and attendance at DSCP appointments.
TERTIARY OBJECTIVES:
I. To assess participant abstinence outcomes as potentially associated with multiple variables: pre-existing use of anti-histamine, anti-inflammatories and dextromethorphan.
OUTLINE:
Patients receive phone calls for 5-10 minutes each from 1 week after start of pre-quit medications to 52 weeks post-target quit day.
After completion of study, patients are followed up for 9 months.
