This phase II trial compares a video toolkit intervention with varenicline and/or nicotine replacement to standard care for smoking cessation among current smokers. The video toolkit is a designed to teach patients about nicotine’s mechanisms of action and approved medications (i.e., varenicline), outcomes relative to other treatment options and address misperceptions and mistrust on uptake of varenicline and other medication for quitting smoking. Varenicline is a drug called a nicotine receptor partial agonist and is used to help people stop smoking by acting the same way nicotine acts in the brain. Nicotine replacement is a drug that uses special products to give small, steady doses of nicotine to help stop cravings and relieve symptoms that occur when a person is trying to quit smoking. Receiving the video toolkit along with varenicline and/or nicotine replacement may improve smoking cessation for current smokers.
Additional locations may be listed on ClinicalTrials.gov for NCT06751927.
Locations matching your search criteria
United States
Illinois
Chicago
University of Chicago Comprehensive Cancer CenterStatus: Active
Contact: Andrea C. King
Phone: 773-702-6181
PRIMARY OBJECTIVES:
I. Develop an educational, health communication tool (video) on nicotine mechanisms of action as they relate to the approved medication varenicline and nicotine replacement in the context of smoking cessation.
II. Examine the effects of a health communication educational tool on smoking cessation knowledge and outcomes within the context of a pilot neuroscience-to-practice intervention trial.
III. Ascertain whether provision of technology access and support will improve program attendance and smoking outcomes.
OUTLINE:
OUTLINE: Patients for aim 1 are assigned to the observational arm, patients for aim 2 are randomized to arm I or II.
OBSERVATIONAL ARM: Patients attend a focus group, over 90-120 minutes, on study.
ARM I: Patients view the video toolkit intervention, consisting of information about nicotine, approved medications for smoking cessation and their outcomes. Patients then meet with a physician assistant and can choose to receive a 12 week supply of varenicline and/or nicotine replacement. Patients who have no access to a video-enabled device or reliable internet may also receive a tablet with access to a telehealth cessation program.
ARM II: Patients receive standard care consisting of discussion about cessation medication options and a standard video on smoking cessation treatment. Patients then meet with a physician assistant and can choose to receive a 12 week supply of varenicline and/or nicotine replacement. Patients who have no access to a video-enabled device or reliable internet may also receive a tablet with access to a telehealth cessation program.
After completion of arm I or II patients are followed up at 12 weeks.
Lead OrganizationUniversity of Chicago Comprehensive Cancer Center
Principal InvestigatorAndrea C. King
