126
Participants
Start Date
January 12, 2021
Primary Completion Date
January 31, 2026
Study Completion Date
January 31, 2026
Varenicline
Varenicline therapy will be 12-week course. On days 1-3 participants will receive 0.5mg once daily; days 4-7 receive 0.5mg twice daily and day 8 until the end of treatment receive 1mg twice daily.
Bupropion
Patients will begin with a dose of 150 mg every morning for 3 days. Then dosage will increase to 150 mg twice daily (morning and evening), for a total daily dose of 300 mg, for 7 to 12 weeks.
Long-acting nicotine replacement therapy
Nicotine replacement therapy (NRT) patches will be used daily from 1-10 weeks depending on participant's smoking history.
Low-intensity counseling
A study coordinator or a member of the treatment team will provide a minimum level of initial counseling, approximately 10-20 minutes in length.
High-intensity counseling
A counselor will provide eight sessions in the first 8 weeks of the study. Up to three follow up sessions over the next 4 months of study will be encouraged, but not required.
No nicotine replacement therapy
Participants in this group will not receive per required need nicotine replacement therapy.
Nicotine Replacement Products
Participants in this group will receive per required need nicotine replacement therapy.
University Of Kentucky, Markey Cancer Center, Lexington
Med Center Health, Bowling Green
Owensboro Health Mitchell Memorial Cancer Center, Owensboro
Joseph Valentino, MD
OTHER