This clinical trial studies different treatment combinations to see which combination works best to help people who smoke cigarettes and also use electronic cigarettes (dual users) quit smoking (smoking cessation). Over the past 10 years, dual use of both burned (combustible) cigarettes and electronic nicotine delivery systems (ENDS) has risen greatly. It is still unknown whether this use pattern helps dual users quit using combustible cigarettes. However, there is a clear need to help dual users quit smoking, given that use of combustible cigarettes is the leading preventable cause of death and disease in the United States (U.S.). This trial will study different treatment combinations which will include different types of smoking cessation medications (varenicline and nicotine patch), smoking cessation counseling at different intensities (4 sessions and 1 session), and different approaches to smoking cessation counseling (focused on dual use/dual cessation and focused on cigarette smoking/cigarette smoking cessation). Researchers hope that by studying these different treatment combinations they will be able to determine which combination works best, which may improve smoking cessation in dual users.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06474299.
Locations matching your search criteria
United States
Wisconsin
Madison
University of Wisconsin Carbone Cancer Center - University HospitalStatus: Active
Contact: Megan Piper
Phone: 608-265-5472
PRIMARY OBJECTIVE:
I. Determine which pharmacologic and counseling approaches are especially effective in helping dual users quit smoking.
SECONDARY OBJECTIVE:
I. Examine the effects of the treatments on variables that may mediate treatment effects on smoking cessation.
EXPLORATORY OBJECTIVES:
I. Examine changes in vaping intensity and vaping cessation.
II. Examine moderators of treatment effects (e.g., cigarette dependence, race, menthol use, ENDS characteristics).
III. Examine whether continued vaping is related to cigarette lapse and relapse amongst those who have quit smoking.
OUTLINE: Participants set a target quit date (TQD) and are randomized to 1 of 8 groups.
GROUP I: Participants receive varenicline orally (PO) once daily (QD) for 3 days starting 7 days pre-TQD. Participants then receive varenicline PO twice daily (BID) starting 4 days pre-TQD and continuing for up to 12 weeks in the absence of unacceptable toxicity. Participants also attend dual focused smoking cessation counseling sessions and receive guidance to quit cigarette smoking and using ENDS on TQD. Additionally, participants attend four video counseling sessions tailored to their smoking cessation counseling type over 15-20 minutes each at 1-2 weeks pre-TQD, 1 day post-TQD, and weeks 1 and 2 post-TQD.
GROUP II: Participants receive varenicline PO QD for 3 days starting 7 days pre-TQD. Participants then receive varenicline PO BID starting 4 days pre-TQD and continuing for up to 12 weeks in the absence of unacceptable toxicity. Participants also attend smoking focused smoking cessation counseling sessions and receive guidance to quit cigarette smoking on TQD. Additionally, participants attend four video counseling sessions tailored to their smoking cessation counseling type over 15-20 minutes each at 1-2 weeks pre-TQD, 1 day post-TQD, and weeks 1 and 2 post-TQD.
GROUP III: Participants receive varenicline PO QD for 3 days starting 7 days pre-TQD. Participants then receive varenicline PO BID starting 4 days pre-TQD and continuing for up to 12 weeks in the absence of unacceptable toxicity. Participants also attend dual focused smoking cessation counseling sessions and receive guidance to quit cigarette smoking and using ENDS on TQD. Additionally, participants attend one video counseling session tailored to their smoking cessation counseling type over 15-20 minutes at 1-2 weeks pre-TQD.
GROUP IV: Participants receive varenicline PO QD for 3 days starting 7 days pre-TQD. Participants then receive varenicline PO BID starting 4 days pre-TQD and continuing for up to 12 weeks in the absence of unacceptable toxicity. Participants also attend smoking focused smoking cessation counseling sessions and receive guidance to quit cigarette smoking on TQD. Additionally, participants attend one video counseling session tailored to their smoking cessation counseling type over 15-20 minutes at 1-2 weeks pre-TQD.
GROUP V: Participants receive nicotine patches and begin using them as per package insert starting on TQD and continuing for up to 12 weeks in the absence of unacceptable toxicity. Participants also attend dual focused smoking cessation counseling sessions and receive guidance to quit cigarette smoking and using ENDS on TQD. Additionally, participants attend four video counseling sessions tailored to their smoking cessation counseling type over 15-20 minutes each at 1-2 weeks pre-TQD, 1 day post-TQD, and weeks 1 and 2 post-TQD.
GROUP VI: Participants receive nicotine patches and begin using them as per package insert starting on TQD and continuing for up to 12 weeks in the absence of unacceptable toxicity. Participants also attend smoking focused smoking cessation counseling sessions and receive guidance to quit cigarette smoking on TQD. Additionally, participants attend four video counseling sessions tailored to their smoking cessation counseling type over 15-20 minutes each at 1-2 weeks pre-TQD, 1 day post-TQD, and weeks 1 and 2 post-TQD.
GROUP VII: Participants receive nicotine patches and begin using them as per package insert starting on TQD and continuing for up to 12 weeks in the absence of unacceptable toxicity. Participants also attend dual focused smoking cessation counseling sessions and receive guidance to quit cigarette smoking and using ENDS on TQD. Additionally, participants attend one video counseling session tailored to their smoking cessation counseling type over 15-20 minutes at 1-2 weeks pre-TQD.
GROUP VIII: Participants receive nicotine patches and begin using them as per package insert starting on TQD and continuing for up to 12 weeks in the absence of unacceptable toxicity. Participants also attend smoking focused smoking cessation counseling sessions and receive guidance to quit cigarette smoking on TQD. Additionally, participants attend one video counseling session tailored to their smoking cessation counseling type over 15-20 minutes at 1-2 weeks pre-TQD.
After completion of study intervention, participants are followed up at weeks 18, 26, 39, and 52.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationUniversity of Wisconsin Carbone Cancer Center - University Hospital
Principal InvestigatorMegan Piper
