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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

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 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

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.

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Who is running the clinical trial?

Yale UniversityLead Sponsor
1,907 Previous Clinical Trials
3,018,793 Total Patients Enrolled
32 Trials studying Smoking
9,414 Patients Enrolled for Smoking
National Institute on Drug Abuse (NIDA)NIH
2,543 Previous Clinical Trials
3,249,120 Total Patients Enrolled
67 Trials studying Smoking
22,415 Patients Enrolled for Smoking
Lisa Fucito, PhDPrincipal InvestigatorYale University
4 Previous Clinical Trials
145 Total Patients Enrolled
~171 spots leftby Apr 2028
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