NCT02048917

Optimization of Smoking Cessation Strategies Concurrent With Treatment of Tobacco Related Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: University of Kentucky · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find an optimal smoking cessation strategy in patients undergoing therapy for lung and head and neck cancers at selected cancer centers in Kentucky by delivering high quality smoking cessation to all enrolled patients. This study will also examine the feasibility of routinely implementing an array of smoking cessation strategies for this patient population.

Detailed description

Subjects enrolled in the study will be placed in one of twelve treatment arms. Subjects in each of the twelve treatment regimens will receive either varenicline or bupropion or long-acting nicotine replacement therapy, with or without use of supplemental nicotine replacement therapy, and in combination with either standard of care smoking cessation counseling or high intensity/motivational smoking cessation counseling.

Conditions

• Lung Cancer
• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	High Intensity Counseling + Long Acting NRT + PRN NRT	High Intensity Counseling + Long Acting NRT + PRN NRT
DRUG	High Intensity Counseling + bupropion + PRN NRT	High Intensity Counseling + bupropion + PRN NRT
DRUG	High Intensity Counseling + varenicline + PRN NRT	High Intensity Counseling + varenicline + PRN NRT
DRUG	High Intensity Counseling + Long Acting NRT	High Intensity Counseling + Long Acting NRT
DRUG	High Intensity Counseling + bupropion	High Intensity Counseling + bupropion
DRUG	High Intensity Counseling + varenicline	High Intensity Counseling + varenicline
DRUG	Low Intensity Counseling + Long Acting NRT + PRN NRT	Low Intensity Counseling + Long Acting NRT + PRN NRT
DRUG	Low Intensity Counseling + bupropion + PRN NRT	Low Intensity Counseling + bupropion + PRN NRT
DRUG	Low Intensity Counseling + varenicline + PRN NRT	Low Intensity Counseling + varenicline + PRN NRT
DRUG	Low Intensity Counseling + Long Acting NRT	Low Intensity Counseling + Long Acting NRT
DRUG	Low Intensity Counseling + bupropion	Low Intensity Counseling + bupropion
DRUG	Low Intensity Counseling + varenicline	Low Intensity Counseling + varenicline

Timeline

• Start date: 2014-07-22
• Primary completion: 2019-05-15
• Completion: 2019-05-15
• First posted: 2014-01-29
• Last updated: 2020-01-29

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study