Comparing Nicotine Delivery, Subjective Effects, and Sensory Experiences of Tobacco Users Using Oral Nicotine Products and Electronic Cigarettes [ZYN Study]

Overseen By Maciej Goniewicz, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Roswell Park Cancer Institute

Must not be taking: Nicotine replacement

Disqualifiers: Untreated conditions, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

15 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Maciej Goniewicz, PhD

Principal Investigator

Roswell Park Comprehensive Cancer Center

Eligibility Criteria

Inclusion Criteria

You smoke more than 5 cigarettes per day for at least 1 year.

Self-report fair or better physical health.

Willingness to abstain from using cigarettes/ST (smokeless tobacco) for 8-10 hours (overnight abstinence) prior to study visits (verified by exhaled-air carbon monoxide < 10ppm).

Exclusion Criteria

You have experienced severe side effects from nicotine or any nicotine replacement products in the past.

Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug.

Nursing female participants.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use oral nicotine products and electronic cigarettes for up to 30 minutes per session

4 weeks

Multiple sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up

Participants' sensory responses are monitored over an extended period

1 year

Treatment Details

Interventions

• Electronic Cigarette
• Oral Nicotine Pouch

Participant Groups

Group I: Order 2 - Electronic Cigarettes and Oral Nicotine product Experimental Treatment 2 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 Cigarettes Experimental Treatment 2 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

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+