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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06077240
Status
Recruiting
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Conditions

  • Nicotine Dependence
  • Smoking
  • Smoking Behaviors

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Aug 20, 2024
Status verified
Mar 2026
Primary completion
Apr 1, 2028
Completion
Apr 1, 2028

Study Design

Enrollment
256 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: E-cigarettes
    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.
  • Experimental: Nicotine Pouches
    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.

Primary Outcome Measure

Aim 1: Average number of cigarettes smoked per day [ Time Frame: From baseline to week 4 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06520-

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By research site
Yale University· New Haven, CT

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