Clinical trial NCT06077240: Effects of E-cigs vs Pouches on Cigarette Smoking and Addiction
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking
Smoking Behaviors
Nicotine Dependence
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-10-11
Enrollment: 256
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Aim 1: Average number of cigarettes smoked per day
timeFrame: From baseline to week 4
measure: Aim 2: Percent of days using non-combustible product
timeFrame: From baseline to week 4
Secondary outcomes:
measure: Aim 1: Percent of days abstinent from cigarettes
timeFrame: From baseline to week 4
measure: Aim 1: Biochemically verified 7 day point-prevalent abstinence from cigarettes
timeFrame: Week 4
measure: Aim 1: Cigarette Dependence
timeFrame: From baseline to week 4
measure: Aim 2: Average use of non-combustible products per day
timeFrame: From baseline to week 4
measure: Aim 2: Continued use of non-combustible products
timeFrame: Week 4 to 6
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Lisa Fucito, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Krysten Bold, PhD
role: PRINCIPAL_INVESTIGATOR
References: