Health TrialsbyHealthPanel

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

ConditionsSmokingSmoking BehaviorsNicotine Dependence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorYale University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

21+ years old

English literate

Currently smoking cigarettes, biochemically confirmed

Disqualifiers

Currently using smoking cessation pharmacotherapies (NRT, bupropion, varenicline)

Currently pregnant or breastfeeding

Significant current medical or psychiatric condition

Known hypersensitivity to propylene glycol

Trial design

Design model

Parallel

Treatments tested in this trial

  • E-cigarette with 2.4% Nicotine with Menthol and Tobacco Flavors

    Behavioral

    Flavor availability is menthol and tobacco/unflavored with lower nicotine concentration.

  • E-cigarette with 2.4% Nicotine with Tobacco Flavor Only

    Behavioral

    Flavor availability is tobacco/unflavored only with lower nicotine concentration.

  • E-cigarette with 5% Nicotine with Menthol and Tobacco Flavors

    Behavioral

    Flavor availability is menthol and tobacco/unflavored with higher nicotine concentration.

  • E-cigarette with 5% Nicotine with Tobacco Flavor Only

    Behavioral

    Flavor availability is tobacco/unflavored only with higher nicotine concentration.

  • Tobacco Pouches with 3mg Nicotine with Menthol and Tobacco Flavors

    Behavioral

    Flavor availability is menthol and tobacco/unflavored with lower nicotine concentration.

  • Tobacco Pouches with 3mg Nicotine with Tobacco Flavor Only

    Behavioral

    Flavor availability is tobacco/unflavored only with lower nicotine concentration.

  • Tobacco Pouches with 6mg Nicotine with Menthol and Tobacco Flavors

    Behavioral

    Flavor availability is menthol and tobacco/unflavored with higher nicotine concentration.

  • Tobacco Pouches with 6mg Nicotine with Tobacco Flavor Only

    Behavioral

    Flavor availability is tobacco/unflavored only with higher nicotine concentration.

Treatment groups

256 Participants
are divided into 2 treatment groups
Group A: E-cigarettesExperimental treatment 4 interventions
Group B: Nicotine PouchesExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Aim 1: Average number of cigarettes smoked per day

Participants will report the total number of cigarettes consumed each day using a well-validated timeline follow-back (TLFB) interview method to assess number of cigarettes smoked per day continuously over the 4-week observational period for each product condition.

Time frame
From baseline to week 4
2

Aim 2: Percent of days using non-combustible product

Participants will report daily use of e-cigarettes or nicotine pouches using a well-validated timeline follow-back (TLFB) interview method continuously over the 4-week observational period to determine the total percent days use of the non-combustible product for each product condition.

Time frame
From baseline to week 4

Secondary outcomes

1

Aim 1: Percent of days abstinent from cigarettes

Participants will report the total number of cigarettes consumed each day using a well-validated timeline follow-back (TLFB) interview method to assess number of cigarettes smoked per day continuously over the 4-week observational period to determine the total percent days abstinent (smoke-free) for each product condition.

Time frame
From baseline to week 4
2

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

Complete switching from cigarettes will be assessed at the end of the study period using self-reported TLFB methods and biochemical verification with expired breath carbon monoxide (CO) testing (CO \< 5ppm) to determine rates of 7-day point-prevalent abstinence

Time frame
Week 4
3

Aim 1: Cigarette Dependence

Cigarette dependence will be measured using the 4-item PROMIS® Short Form v1.0 - Smoking Nicotine Dependence for All Smokers 4a. Each item is scored from 1-5 with the range of scores from 4-20 with higher scores representing greater cigarette dependence.

Time frame
From baseline to week 4
4

Aim 2: Average use of non-combustible products per day

Participants will report daily e-cigarette and nicotine pouch quantity and frequency consumed using a well-validated timeline follow-back (TLFB) interview method to use continuously over the 4-week observational period for each product condition.

Time frame
From baseline to week 4

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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