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

Yale University

Status: Enrolling

Conditions: Nicotine Dependence; Smoking Behaviors; Smoking

Treatments: Behavioral: Tobacco Pouches with 6mg Nicotine with Tobacco Flavor Only; Behavioral: Tobacco Pouches with 3mg Nicotine with Tobacco Flavor Only; Behavioral: Tobacco Pouches with 6mg Nicotine with Menthol and Tobacco Flavors; Behavioral: Tobacco Pouches with 3mg Nicotine with Menthol and Tobacco Flavors; Behavioral: E-cigarette with 2.4% Nicotine with Menthol and Tobacco Flavors; Behavioral: E-cigarette with 5% Nicotine with Menthol and Tobacco Flavors; Behavioral: E-cigarette with 2.4% Nicotine with Tobacco Flavor Only; Behavioral: E-cigarette with 5% Nicotine with Tobacco Flavor Only

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06077240

U54DA036151 (U.S. NIH Grant/Contract)

2000035286

Details and patient eligibility

About

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.

Full 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.

Enrollment: 256 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 21+ years old
• English literate
• Currently smoking cigarettes, biochemically confirmed
• Not planning a smoking cessation attempt or to use smoking cessation pharmacotherapies (NRT, bupropion, varenicline) in the next month.

Exclusion criteria

• Currently using any smoking cessation services and/or pharmacotherapies
• Currently pregnant or breastfeeding
• Significant current medical or psychiatric condition
• Known hypersensitivity to propylene glycol.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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256 participants in 2 patient groups

E-cigarettes

Experimental group

Description:

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.

Treatment:

Behavioral: E-cigarette with 5% Nicotine with Tobacco Flavor Only

Behavioral: E-cigarette with 2.4% Nicotine with Tobacco Flavor Only

Behavioral: E-cigarette with 5% Nicotine with Menthol and Tobacco Flavors

Behavioral: E-cigarette with 2.4% Nicotine with Menthol and Tobacco Flavors

Nicotine Pouches

Experimental group

Description:

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.

Treatment:

Behavioral: Tobacco Pouches with 6mg Nicotine with Menthol and Tobacco Flavors

Behavioral: Tobacco Pouches with 3mg Nicotine with Menthol and Tobacco Flavors

Behavioral: Tobacco Pouches with 3mg Nicotine with Tobacco Flavor Only

Behavioral: Tobacco Pouches with 6mg Nicotine with Tobacco Flavor Only