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Comparing Nicotine Delivery, Subjective Effects, and Sensory Experiences of Tobacco Users Using Oral Nicotine Products and Electronic Cigarettes [ZYN Study]
N/A
Waitlist Available
Led By Nicholas Felicione, PhD
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial tests how appealing ZYN, a nicotine pouch, is to people who use cigarettes, smokeless tobacco, and other nicotine products. ZYN offers a tobacco-free way to consume nicotine and delivers it quickly without significant adverse effects.
Eligible Conditions
- Tobacco Use
- Smokeless Tobacco Cessation
- Tobacco Smoking
- Smoking/Cigarette Smoking
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in nicotine boost
Change in sensory response
Secondary study objectives
Change is stress markers
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Order 2 - Electronic Cigarettes and Oral Nicotine productExperimental Treatment2 Interventions
Participants will use each prodcut for up to 30 minutes but will also be permitted to stop use before the end of the 30-minute ad lib use period
Group II: Order 1 - Oral Nicotine product - ZYN and Electronic CigarettesExperimental Treatment2 Interventions
Participants will use each product for up to a 30 minute interval But will also be permitted to stop use before the end of the 30-minute ad lib use period
Find a Location
Who is running the clinical trial?
Roswell Park Cancer InstituteLead Sponsor
412 Previous Clinical Trials
32,720 Total Patients Enrolled
Nicholas Felicione, PhDPrincipal InvestigatorRoswell Park Comprehensive Cancer Center
Maciej Goniewicz, PhDPrincipal InvestigatorRoswell Park Comprehensive Cancer Center
1 Previous Clinical Trials
216 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You smoke more than 5 cigarettes per day for at least 1 year.You have experienced severe side effects from nicotine or any nicotine replacement products in the past.You currently have medical or mental health conditions that are not being treated.You currently use tobacco or nicotine products, like e-cigarettes, more than two days a week.You currently use smokeless tobacco or oral nicotine products on a daily basis.You smoke more than 5 cigarettes a day for at least a year, OR you use 5 or more units of tobacco per day for at least a year.You currently smoke cigarettes every day.You feel mentally well and have good mental health.You have been using at least 5 units of a medication every day for one year or longer.You use certain types of smokeless tobacco or nicotine patches.
Research Study Groups:
This trial has the following groups:- Group 1: Order 1 - Oral Nicotine product - ZYN and Electronic Cigarettes
- Group 2: Order 2 - Electronic Cigarettes and Oral Nicotine product
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Tobacco Use Patient Testimony for trial: Trial Name: NCT05030194 — N/A