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Behavioral Intervention

E-cigarettes vs Nicotine Pouches for Smoking Cessation

N/A

Recruiting

Led By Lisa Fucito, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

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

Must have

21+ years old

Not planning a smoking cessation attempt or to use smoking cessation pharmacotherapies (NRT, bupropion, varenicline) in the next month.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 4 to 6

Awards & highlights

No Placebo-Only Group

Summary

This trial will study 256 adult smokers to see if switching to e-cigarettes or nicotine pouches helps them reduce smoking. Visits every 2 weeks will track progress over 4 weeks. Final results will show which products and ingredients are most effective.

Who is the study for?

Adults over 21 who currently smoke cigarettes and are willing to try e-cigarettes or nicotine pouches. They must speak English, not be planning to quit smoking or use cessation drugs in the next month, and cannot be pregnant, breastfeeding, using other cessation services, or have a serious medical condition or allergy to propylene glycol.

What is being tested?

The trial is testing if switching smokers from cigarettes to either e-cigarettes with varying nicotine levels and flavors (tobacco only or menthol) or flavored tobacco pouches with different nicotine strengths can reduce cigarette smoking over a period of 4 weeks.

What are the potential side effects?

Potential side effects may include irritation from flavors or propylene glycol in e-cigarettes, nicotine withdrawal symptoms when reducing cigarette use such as cravings, headaches, mood swings; and possible addiction to the alternative products.

Eligibility Criteria

Inclusion Criteria

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

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I am over 21 years old.

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I am not planning to quit smoking or use any quitting aids soon.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 4 to 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 4 to 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4 to 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Aim 1: Average number of cigarettes smoked per day

Aim 2: Percent of days using non-combustible product

Secondary study objectives

Aim 1: Biochemically verified 7 day point-prevalent abstinence from cigarettes

Aim 1: Cigarette Dependence

Aim 1: Percent of days abstinent from cigarettes

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Nicotine PouchesExperimental Treatment4 Interventions

Adults who smoke cigarettes will be randomized to receive nicotine pouches for a duration of 4 weeks and to 1 of 4 possible regulatory scenarios within products where flavor availability is either menthol and tobacco/unflavored available or tobacco/unflavored only available, and nicotine concentration is either higher (6mg pouch) or lower (3mg pouch). Participants will return for bi-weekly research visits (in person or remote videocall) to complete measures for study aims. They will complete a final follow-up at Week 6 to assess maintenance of cigarette reduction and willingness to continue using products once they are no longer provided.

Group II: E-cigarettesExperimental Treatment4 Interventions

Adults who smoke cigarettes will be randomized to receive e-cigarettes for a duration of 4 weeks and to 1 of 4 possible regulatory scenarios within products where flavor availability is either menthol and tobacco/unflavored available or tobacco/unflavored only available, and nicotine concentration is either higher (5% e-cig) or lower (2.4% e-cig). Participants will return for bi-weekly research visits (in person or remote videocall) to complete measures for study aims. They will complete a final follow-up at Week 6 to assess maintenance of cigarette reduction and willingness to continue using products once they are no longer provided.

0 / 2Eligibility criteria met