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

Smoking Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06077240
• Other study ID #: 2000035286
• Secondary ID: U54DA036151
• Status: Recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: January 2029

Study information

• Verified date: April 2024
• Source: Yale University
• Contact: Lisa M. Fucito, PhD
• Phone: 203-200-1470
• Email: lisa.fucito[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 256
• Est. completion date: January 2029
• Est. primary completion date: January 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nicotine Dependence
• Smoking
• Smoking Behaviors
• Tobacco Use Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From baseline to week 4
Primary	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.	From baseline to week 4
Secondary	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.	From baseline to week 4
Secondary	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	Week 4
Secondary	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.	From baseline to week 4
Secondary	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.	From baseline to week 4
Secondary	Aim 2: Continued use of non-combustible products	Participants will report daily use of e-cigarettes or nicotine pouches using a well-validated timeline follow-back (TLFB) interview method to determine the total percent days use of the non-combustible product for each product condition during the follow-up period.	Week 4 to 6