This phase IV trial tests if higher dose (augmented) nicotine replacement therapy (NRT) is better at increasing quit rates among people that smoke both cigarettes and electronic (e-) cigarettes (dual users). Tobacco use is one of the leading preventable causes of cancer-related disease and death. Tobacco products have changed over the years with an increase in e-cigarette use. E-cigarettes may be used to help people quit cigarettes, but many people continue to use e-cigarettes without quitting smoking. Nicotine is an addictive, poisonous chemical found in tobacco. NRT uses nicotine patches and lozenges to help people quit vaping and smoking by providing low levels of nicotine to minimize withdrawal symptoms. Giving augmented NRT may increase quit rates among dual users.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06087328.
PRIMARY OBJECTIVES:
I. Evaluate, in a preliminary manner, the effect of augmented doses of NRT, compared to a standard dose, on outcomes from a dual use cessation attempt.
II. Evaluate the feasibility, acceptability, and engagement with the treatment intervention.
OUTLINE: Participants are randomized to 1 of 3 arms.
ARM A: Participants select a quit day and receive one nicotine patch transdermally once daily (QD) as well as nicotine lozenges orally (PO) 5-20 times daily for 28 days in the absence of unacceptable toxicity. Participants also receive behavioral quit support informational booklet.
ARM B: Participants select a quit day and receive two differing dose nicotine patches transdermally QD as well as nicotine lozenges PO 5-30 times daily for 28 days in the absence of unacceptable toxicity. Participants also receive behavioral quit support informational booklet.
ARM C: Participants select a quit day and receive two same dose nicotine patches transdermally QD as well as nicotine lozenges PO 5-40 times daily for 28 days in the absence of unacceptable toxicity. Participants also receive behavioral quit support informational booklet.
After completion of study intervention, participants are followed up at day 56.
Lead OrganizationMedical University of South Carolina
Principal InvestigatorAmanda Palmer
