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Nicotine Pouches for Tobacco Addiction

N/A

Waitlist Available

Led By Jonathan Foulds, PhD

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Commonly smoke ≥ 5 cigarettes per day (at least 2 days/week) for at least the prior 12 months

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 16

Awards & highlights

Study Summary

This trial will study the effects of a new oral nicotine pouch to see if it can reduce cigarette smoking and what its health effects are.

Who is the study for?

This trial is for daily smokers with a baseline exhaled CO of ≥6 ppm, who read and write English, have internet access, and want to cut down smoking by at least 50% using nicotine pouches. Not for pregnant women, those planning pregnancy soon, people with recent severe illnesses or hospitalizations, serious respiratory diseases, kidney/liver disease or heavy illegal drug use.Check my eligibility

What is being tested?

The study tests new oral nicotine pouches in different strengths (0 mg, 3 mg, 6 mg) and flavors (Smooth and Wintergreen), aiming to reduce cigarette use by substituting these pouches over 16 weeks. Participants will be randomly assigned a product variant to see how it affects health indicators and smoking habits.See study design

What are the potential side effects?

While the specific side effects are not listed here, typical side effects from nicotine products can include mouth irritation, hiccups, sore throat, headache, nausea or heartburn. Long-term health impacts are part of what this trial aims to assess.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been smoking at least 5 cigarettes daily for over a year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Concentration of urinary NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol)

Secondary outcome measures

Concentration of urinary cotinine

Level of carbon monoxide in exhaled breath

Mean number of cigarettes per day

+2 more

Trial Design

6Treatment groups

Experimental Treatment

Group I: 6 mg + Wintergreen flavorExperimental Treatment2 Interventions

Participants are provided with high strength (6 mg) nicotine pouches with wintergreen flavor.

Group II: 6 mg + Smooth flavorExperimental Treatment2 Interventions

Participants are provided with high strength (6 mg) nicotine pouches with smooth flavor.

Group III: 3 mg + Wintergreen flavorExperimental Treatment2 Interventions

Participants are provided with medium strength (3 mg) nicotine pouches with wintergreen flavor.

Group IV: 3 mg + Smooth flavorExperimental Treatment2 Interventions

Participants are provided with medium strength (3 mg) nicotine pouches with smooth flavor.

Group V: 0 mg + Wintergreen flavorExperimental Treatment2 Interventions

Participants are provided with zero strength (0 mg) nicotine pouches with wintergreen flavor.

Group VI: 0 mg + Smooth flavorExperimental Treatment2 Interventions

Participants are provided with zero strength (0 mg) nicotine pouches with smooth flavor.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor

492 Previous Clinical Trials

2,798,447 Total Patients Enrolled

Jonathan Foulds, PhDPrincipal InvestigatorPenn State College of Medicine

4 Previous Clinical Trials

548 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for the trial limited to individuals aged 80 and under?

"The rules of involvement for this experiment stipulate that participants must be at least 21 years old and no older than 70."

Answered by AI

What are the criteria for enrolling in this experiment?

"This study, which is accepting 375 participants, necessitates that potential enrollees have a history of tobacco addiction and are between 21-70 years old."

Answered by AI

Are there any open enrollment opportunities in this research trial?

"Clinicaltrials.gov reveals that this particular medical trial is no longer recruiting subjects, the latest update being on September 20th of 2023. Despite this, there are still 115 other active studies currently enrolling patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Use of Nicotine Pouches Among Daily Smokers

Jonathan Foulds 2024. "Use of Nicotine Pouches Among Daily Smokers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06043362.