Nicotine Pouches for Smoking

Recruiting at 4 trial locations

Overseen ByJohn Darnell

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: RAI Services Company

Must not be taking: Anticoagulants, Smoking cessation aids

Disqualifiers: Diabetes, Cancer history, Hypertension, others

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

Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This will be a multi center open label, randomized, controlled, switching parallel-group study designed to assess changes in select biomarkers of exposure (BoE) in generally healthy smokers following a 5 day in-clinic switch to use of nicotine Pouch investigational products (IPs) compared to continued usual brand (UB) cigarette smoking or smoking abstinence.

Research Team

Brian Keyser, PhD

Principal Investigator

Reynolds American

Eligibility Criteria

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.

Inclusion Criteria

Agrees to use assigned IP throughout the study period

Smokes an average of at least 10 cigarettes per day (CPD) and inhales the smoke for at least six months prior to Screening

Self-reports that cigarettes are their primary tobacco- or nicotine-containing product use within 30 days of Screening

See 11 more

Exclusion Criteria

Systolic blood pressure (BP) of > 160 mmHg or a diastolic BP of > 95 mmHg

My hemoglobin level is below the normal range for my gender.

I haven't used smoking cessation aids in the last 30 days.

See 21 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are switched to exclusive use of nicotine pouches or continue smoking their usual brand cigarettes or abstain from smoking for 5 days

5 days

In-clinic stay

Follow-up

Participants are monitored for changes in biomarkers of exposure after the treatment phase

2 weeks

Treatment Details

Interventions

Nicotine Pouch

Trial Overview 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.

Participant Groups

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