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Recruiting NCT06077240

Effects of E-cigs vs Pouches on Cigarette Smoking and Addiction

No phase Interventional Smoking Smoking Behaviors Nicotine Dependence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: E-cigarette with 2.4% Nicotine with Menthol and Tobacco Flavors, E-cigarette with 2.4% Nicotine with Tobacco Flavor Only, E-cigarette with 5% Nicotine with Menthol and Tobacco Flavors, E-cigarette with 5% Nicotine with Tobacco Flavor Only.
Who it may be relevant to
Registry conditions: Smoking, Smoking Behaviors, Nicotine Dependence. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluating The Effects Of E-cigarettes Versus Oral Nicotine Pouches and Product Constituents (Menthol Flavor, Nicotine Concentration) On Adult Cigarette Smoking and Addiction

Overview

The study will recruit an anticipated 256 adults who currently smoke cigarettes and report a willingness to try switching to alternative, non-combustible products. Participants will be randomized to receive either e-cigarettes or 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 (5% e-cig, 6mg pouch) or lower (2.4% e-cig, 3mg pouch). Participants will return for bi-weekly research visits (in person or remote videocall) to complete measures for study aims. Participants 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. The investigators expect to observe which products and constituents lead to greater smoking reduction.

Detailed description

The study includes 5 visit and assessments over 6 weeks. The intake visit will take approximately 60 minutes and subsequent visits will take approximately 30 minutes. The study is proposed to run for 5 years.

Interventions

  • Behavioral E-cigarette with 2.4% Nicotine with Menthol and Tobacco Flavors
    Flavor availability is menthol and tobacco/unflavored with lower nicotine concentration.
  • Behavioral E-cigarette with 2.4% Nicotine with Tobacco Flavor Only
    Flavor availability is tobacco/unflavored only with lower nicotine concentration.
  • Behavioral E-cigarette with 5% Nicotine with Menthol and Tobacco Flavors
    Flavor availability is menthol and tobacco/unflavored with higher nicotine concentration.
  • Behavioral E-cigarette with 5% Nicotine with Tobacco Flavor Only
    Flavor availability is tobacco/unflavored only with higher nicotine concentration.
  • Behavioral Tobacco Pouches with 3mg Nicotine with Menthol and Tobacco Flavors
    Flavor availability is menthol and tobacco/unflavored with lower nicotine concentration.
  • Behavioral Tobacco Pouches with 3mg Nicotine with Tobacco Flavor Only
    Flavor availability is tobacco/unflavored only with lower nicotine concentration.
  • Behavioral Tobacco Pouches with 6mg Nicotine with Menthol and Tobacco Flavors
    Flavor availability is menthol and tobacco/unflavored with higher nicotine concentration.
  • Behavioral Tobacco Pouches with 6mg Nicotine with Tobacco Flavor Only
    Flavor availability is tobacco/unflavored only with higher nicotine concentration.

Primary outcome measures

  • Aim 1: Average number of cigarettes smoked per day [Time frame: From baseline to week 4]
  • Aim 2: Percent of days using non-combustible product [Time frame: From baseline to week 4]
Secondary outcome measures (5)
  • Aim 1: Percent of days abstinent from cigarettes [Time frame: From baseline to week 4]
  • Aim 1: Biochemically verified 7 day point-prevalent abstinence from cigarettes [Time frame: Week 4]
  • Aim 1: Cigarette Dependence [Time frame: From baseline to week 4]
  • Aim 2: Average use of non-combustible products per day [Time frame: From baseline to week 4]
  • Aim 2: Continued use of non-combustible products [Time frame: Week 4 to 6]

Eligibility criteria

Inclusion criteria

  • 21+ years old
  • English literate
  • Currently smoking cigarettes, biochemically confirmed

Exclusion criteria

  • Currently using smoking cessation pharmacotherapies (NRT, bupropion, varenicline)
  • Currently pregnant or breastfeeding
  • Significant current medical or psychiatric condition
  • Known hypersensitivity to propylene glycol

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Other

Study locations

United States · 1 center
  • Yale University — New Haven

Identifiers

NCT: NCT06077240 · 2000035286 · U54DA036151

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗