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Nicotine Pouches vs Cigarettes Appeal in Smokers

Q: Have the enrollment requirements for this clinical trial been fulfilled yet?

<p>As no updates have been made to the clinicaltrials.gov page since April 29th 2022, this trial is not actively searching for patients at present. However, 11 other studies are still looking to enrol new participants.</p>

Phase < 1

Waitlist Available

Led By Brittney L Keller-Hamilton, PhD, MPH

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

History of cardiac event or distress within the past 3 months.

Self-reported diagnosis of lung disease including asthma (if uncontrolled or worse than usual), cystic fibrosis, or chronic obstructive pulmonary disease.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

Study Summary

This trial is testing how addictive nicotine pouches are compared to cigarettes, in smokers from Appalachian Ohio and Ohio. Results may help reduce tobacco-related disparities.

Who is the study for?

This trial is for Ohio residents aged 21 or older who smoke at least 5 cigarettes daily and have used nicotine pouches in the last 3 months. It's not for those trying to quit tobacco, pregnant, breastfeeding, with recent heart issues or uncontrolled lung diseases like severe asthma, cystic fibrosis, or COPD.Check my eligibility

What is being tested?

The study compares the potential of nicotine pouches versus cigarette smoking to cause addiction among smokers in Appalachian Ohio. Participants will answer questionnaires and their use of both products will be assessed.See study design

What are the potential side effects?

Since this trial involves using existing tobacco products rather than new medications, side effects are those typically associated with nicotine use such as increased heart rate, dizziness, nausea, and potential addiction.

Eligibility Criteria

Inclusion Criteria

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

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I have had a heart problem in the last 3 months.

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I have a lung condition like severe asthma, cystic fibrosis, or COPD.

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I am 21 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Evaluate plasma nicotine concentration at t=30 minutes for each product.

Secondary outcome measures

Aim 1: Public health effect of NPs in Appalachian Ohio - if NPs can be used as a substitute for cigarette smoking

Evaluate plasma nicotine concentrations at t=5 through t=90 minutes

Evaluate product appeal across all 3 products

+1 more

Other outcome measures

Aim 1 and 2: Nicotine pharmacokinetics

Aim 1: Intentions to use and switch to NPs - quit intentions will be assessed using a 10 question survey

Aim 2: Public health effect of NPs in adult smokers - if NPs can be used as a substitute for cigarette smoking.

+1 more

Trial Design

6Treatment groups

Experimental Treatment

Active Control

Group I: Aim 2: Arm III (3mg NP)Experimental Treatment2 Interventions

Patients receive nicotine pouch PO over 30 minutes at visits 1, 2, and 3.

Group II: Aim 2: Arm II (3mg NP)Experimental Treatment2 Interventions

Patients receive nicotine pouch PO over 30 minutes at visits 1, 2, and 3.

Group III: Aim 2: Arm I (3mg NP)Experimental Treatment2 Interventions

Patients receive nicotine pouch PO over 30 minutes at visits 1, 2, and 3.

Group IV: Aim 1: Arm II (higher dose nicotine pouches)Experimental Treatment2 Interventions

Patients receive higher dose nicotine pouch PO over 30 minutes at visits 1, 2, and 3.

Group V: Aim 1: Arm I (lower dose nicotine pouch)Experimental Treatment2 Interventions

Patients receive lower dose nicotine pouch PO over 30 minutes at visits 1, 2, and 3.

Group VI: Aim 1: Arm III (cigarette smoking)Active Control2 Interventions

Patients smoke usual brand of cigarettes, taking one puff every 30 seconds over 5 minutes at visits 1, 2, and 3.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor

320 Previous Clinical Trials

290,112 Total Patients Enrolled

Brittney L Keller-Hamilton, PhD, MPHPrincipal InvestigatorOhio State University Comprehensive Cancer Center

3 Previous Clinical Trials

315 Total Patients Enrolled

Media Library

Cigarette Smoking Clinical Trial Eligibility Overview. Trial Name: NCT05236894 — Phase < 1

Cancer Research Study Groups: Aim 2: Arm II (3mg NP), Aim 1: Arm I (lower dose nicotine pouch), Aim 1: Arm II (higher dose nicotine pouches), Aim 1: Arm III (cigarette smoking), Aim 2: Arm I (3mg NP), Aim 2: Arm III (3mg NP)

Cancer Clinical Trial 2023: Cigarette Smoking Highlights & Side Effects. Trial Name: NCT05236894 — Phase < 1

Cigarette Smoking 2023 Treatment Timeline for Medical Study. Trial Name: NCT05236894 — Phase < 1

Frequently Asked Questions

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

Have the enrollment requirements for this clinical trial been fulfilled yet?

"As no updates have been made to the clinicaltrials.gov page since April 29th 2022, this trial is not actively searching for patients at present. However, 11 other studies are still looking to enrol new participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Appeal of Nicotine Pouches Versus Cigarettes in the Ohio Appalachia Population

Brittney Keller-Hamilton 2022. "Appeal of Nicotine Pouches Versus Cigarettes in the Ohio Appalachia Population". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05236894.