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Behavioural Intervention

Flavored Nicotine Pouches for Smoking Reduction

N/A

Recruiting

Led By Hui Cheng, PhD

Research Sponsored by Altria Client Services LLC

Eligibility Criteria Checklist

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

Must have

Healthy adults who smoke cigarettes and are 22 to 65 years of age (inclusive) at screening.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of week 3, end of week 6

Awards & highlights

Study Summary

This trial studies if flavored nicotine pouches reduce cigarette smoking amongst adult smokers. Participants will get products with or without flavors to use for 6 weeks and see if reduction in smoking is greater.

Who is the study for?

Adults aged 22-65 who smoke at least 5 cigarettes daily for the past year, want to switch to a smoke-free tobacco product, and can use a smartphone with text and data. Excluded are those in poor health or with certain medical conditions, involved in tobacco litigation or industry, pregnant/nursing women not using birth control, heavy marijuana users, and recent participants in other tobacco studies.Check my eligibility

What is being tested?

The trial is testing if flavored nicotine pouches (Berry, Citrus, Cinnamon etc.) help smokers reduce cigarette use more than non-flavored pouches over six weeks. Participants will be given these products to see if flavors lead to greater smoking reduction compared to just the Original flavor.See study design

What are the potential side effects?

While specific side effects aren't listed for this study of nicotine pouches, common ones may include mouth irritation or sores, gum disease symptoms worsening if pre-existing conditions exist. Allergic reactions could occur especially among those sensitive to menthol or phenylalanine.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am a healthy adult aged 22-65 who smokes cigarettes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of week 3, end of week 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of week 3, end of week 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of week 3, end of week 6 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in cigarette-related toxicant exposure

Cigarette-related toxicant exposure

Secondary outcome measures

CO-verified smoking abstinence

Change in self-reported cigarette consumption

Number of cigarettes smoked

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Complete flavor profile of on! nicotine pouchesExperimental Treatment1 Intervention

This study arm will provided with access to all varieties of 4mg on! nicotine pouch products throughout the trial.

Group II: Non-Flavored then complete flavor on! nicotine pouchesActive Control1 Intervention

This study arm will provided with access to non-flavored (i.e., Original) 4mg on! nicotine pouch products during the first 3 weeks of the trial and then access to all varieties of 4mg on! nicotine pouch products during the last 3 weeks of the trial.

Group III: Non-Flavored on! nicotine pouches onlyActive Control1 Intervention

This study arm will provided with access to non-flavored (i.e., Original) 4mg on! nicotine pouch products throughout the trial.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rose Research Center, LLCIndustry Sponsor

15 Previous Clinical Trials

1,057 Total Patients Enrolled

Altria Client Services LLCLead Sponsor

7 Previous Clinical Trials

1,358 Total Patients Enrolled

Hui Cheng, PhDPrincipal InvestigatorALCS

Frequently Asked Questions

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

Are elderly individuals being welcomed into this clinical trial?

"As outlined in the qualifiers for participation, only patients aged 22 to 65 are eligible for this clinical trial."

Answered by AI

Do I meet the prerequisites to partake in this experiment?

"400 hopefuls can be accepted into this trial, so long as they are between the ages of 22 and 65 years old and have a smoking history."

Answered by AI

What is the current enrollment capacity of this experiment?

"Affirmative. Information available on clinicaltrials.gov shows that this medical experiment was initially posted on September 11th, 2023 and is still actively recruiting patients. The trial requires 400 test subjects from a single site to be enrolled."

Answered by AI

Is the intake of new participants open for this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this research endeavour is still recruiting patients; it was initially posted on September 11th 2023 and has since undergone an update on October 5th 2023. The total number of participants needed for the trial is 400 at one location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Flavored on!® Nicotine Pouch Products on Smoking Behaviors: a SMART

2023. "Effect of Flavored on!® Nicotine Pouch Products on Smoking Behaviors: a SMART". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06072547.