Tobacco Treatment Optimization and Preferences During Concurrent Cancer Treatment

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

126

Participants

Timeline

Start Date

January 12, 2021

Primary Completion Date

January 31, 2026

Study Completion Date

January 31, 2026

Conditions
Smoking CessationCancer, Treatment-Related
Interventions
DRUG

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.

DRUG

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.

DRUG

Long-acting nicotine replacement therapy

Nicotine replacement therapy (NRT) patches will be used daily from 1-10 weeks depending on participant's smoking history.

BEHAVIORAL

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.

BEHAVIORAL

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.

OTHER

No nicotine replacement therapy

Participants in this group will not receive per required need nicotine replacement therapy.

DRUG

Nicotine Replacement Products

Participants in this group will receive per required need nicotine replacement therapy.

Trial Locations (3)

40536

University Of Kentucky, Markey Cancer Center, Lexington

42101

Med Center Health, Bowling Green

42303

Owensboro Health Mitchell Memorial Cancer Center, Owensboro

All Listed Sponsors
lead

Joseph Valentino, MD

OTHER