Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263, United States
NCT Number: NCT05030194
To pilot test the appeal of non-tobacco oral nicotine products in cigarette smokers, smokeless tobacco users, and oral nicotine users.
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Notify Me21 year–55 year
All sexes
Interventional
Not applicable
Buffalo, New York, 14263, United States
This study will assess the use, nicotine delivery, subjective response, and sensory appeal of an oral nicotine product (ZYN) compared to electronic nicotine delivery systems (ENDS, Vuse Alto) in cigarette smokers, smokeless tobacco users and oral nicotine users.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
a. Uses >=5 units/day for >=1 year
Exclusion criteria
Participants engage in 30 minutes of an oral nicotine product. In those 30 minutes the product can be used as much or as little as preferred.
Other names: Vuse Alto
Participants will be instructed to place a 6mg nicotine pouch in their mouth between gum and lip for up to 30 minutes.
Other names: ZYN
Time frame: up to week 4
will be measured as the post bout plasma nicotine concentration minus the pre-bout plasma nicotine concentration
Time frame: up to 1 year
will be measured by a Questionnaire scored on a 0-100 visual analog scale with 0 (Not at all) to 100 (Extremely).
Time frame: Up to 4 weeks
Saliva will be collected before and after product use of each product to establish plasma nicotine concentrations
Roswell Park Cancer Institute
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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