This phase III trial compares nicotine oral pouches and nicotine mini lozenges to no nicotine product to see how well they work in serving as a substitute for cigarettes when trying to switch from smoking. Cigarette use continues to contribute to significant burdens in the United States, including death and high healthcare expenses. Despite the availability of counseling and drug therapies to support smoking cessation, only 1 in 4 smokers that use these resources are able to quit long term. One potential strategy to reduce harm caused by smoking is for smokers to switch from cigarettes to other forms of nicotine delivery that are likely to produce less harm. Nicotine oral pouches and mini lozenges are likely to be less harmful than cigarettes as there is no burning and they contain fewer poisonous ingredients. Nicotine oral pouches contain nicotine that may be used as a substitute for the active ingredient in tobacco. Upon administration via placement between gum and lip, nicotine is absorbed in the mouth. Nicotine mini lozenges are a hard candy-like tablets that contain a small dose of nicotine. The nicotine is absorbed through the lining of the mouth and goes into the blood. Nicotine oral pouches or mini lozenges may be an effective substitute for cigarettes when trying to switch from smoking.
Additional locations may be listed on ClinicalTrials.gov for NCT06595459.
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. Evaluate the ability of 3-mg and 6-mg nicotine pouches to substitute for combusted cigarettes in the 3-week switching trial.
SECONDARY OBJECTIVE:
I. Investigate product usage patterns and product effects that promote or hinder cigarette substitution.
OUTLINE: Participants are randomized to 1 of 4 arms.
ARM I: Participants use lower dose nicotine oral pouches as they would like and smoke as usual for one week in the absence of unacceptable toxicity. Participants then abstain from smoking and use lower dose nicotine oral pouches as they would like for three weeks in the absence of unacceptable toxicity.
ARM II: Participants use higher dose nicotine oral pouches as they would like and smoke as usual for one week in the absence of unacceptable toxicity. Participants then abstain from smoking and use higher dose nicotine oral pouches as they would like for three weeks in the absence of unacceptable toxicity.
ARM III: Based on time to first cigarette, participants use lower or higher dose nicotine mini lozenges as they would like and smoke as usual for one week in the absence of unacceptable toxicity. Participants then abstain from smoking and use lower or higher dose nicotine mini lozenges as they would like for three weeks in the absence of unacceptable toxicity.
ARM IV: Participants do not receive a nicotine product and smoke as usual for one week in the absence of unacceptable toxicity. Participants then abstain from smoking for three weeks in the absence of unacceptable toxicity.
Additionally, all patients undergo saliva sample collection throughout the study.
After completion of study intervention, patients are followed up at 3 months post-visit 1.
Lead OrganizationUniversity of Wisconsin Carbone Cancer Center - University Hospital
Principal InvestigatorMegan Piper
