Nicotine Pouches for Smoking

N/A

Recruiting

Led By Brian Keyser, PhD

Research Sponsored by RAI Services Company

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 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how biomarkers change in healthy smokers when they switch to using a new nicotine product for 5 days, compared to continuing to smoke their usual cigarettes or quitting smoking altogether.

Who is the study for?

This trial is for generally healthy smokers who want to switch from regular cigarettes to nicotine pouches or try smoking abstinence. Specific details on eligibility criteria are not provided, but typically participants must meet certain health standards and be willing to follow the study's protocol.

What is being tested?

The study is testing how switching from usual brand cigarettes to different strengths of nicotine pouches (4 mg, 8 mg, 10 mg, and 12 mg) or stopping smoking affects exposure to certain harmful chemicals. Participants will be randomly assigned to one of these new options or continue with their regular smoking habits for five days in a clinic setting.

What are the potential side effects?

Possible side effects may include typical nicotine-related symptoms such as headache, nausea, dizziness, sleep disturbances, and mouth irritation due to the use of nicotine pouches.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups

Experimental Treatment

Active Control

Group I: Smoking AbstinenceExperimental Treatment1 Intervention

Subjects will not use any tobacco or nicotine containing products.

Group II: Continued UB cigarette smokingExperimental Treatment1 Intervention

Subjects will continue use of their Usual Brand Cigarettes.

Group III: Nicotine Pouch P1312914, 4 mg nicotineActive Control1 Intervention