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

NCT06077240 | Recruiting

• 2 other identifiers: 2000035286U54DA036151
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking; Smoking Behaviors; Nicotine Dependence

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Aim 1: Percent of days abstinent from cigarettes

  From baseline to week 4

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

  Week 4

• Aim 1: Cigarette Dependence

  From baseline to week 4

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

  From baseline to week 4

• Aim 2: Continued use of non-combustible products

  Week 4 to 6

Study Arms (2)

E-cigarettes

EXPERIMENTAL

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.

Behavioral: E-cigarette with 2.4% Nicotine with Menthol and Tobacco Flavors; 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 5% Nicotine with Tobacco Flavor Only

Nicotine Pouches

EXPERIMENTAL

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.

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 Menthol and Tobacco Flavors; Behavioral: Tobacco Pouches with 6mg Nicotine with Tobacco Flavor Only

Interventions

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

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

E-cigarettes

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

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

E-cigarettes

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

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

E-cigarettes

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

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

E-cigarettes

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

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

Nicotine Pouches

Tobacco Pouches with 3mg Nicotine with Tobacco Flavor Only BEHAVIORAL

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

Nicotine Pouches

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

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

Nicotine Pouches

Tobacco Pouches with 6mg Nicotine with Tobacco Flavor Only BEHAVIORAL

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

Nicotine Pouches

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + years old
• English literate
• Currently smoking cigarettes, biochemically confirmed

You may not qualify if:

• Currently using smoking cessation pharmacotherapies (NRT, bupropion, varenicline)
• Currently pregnant or breastfeeding
• Significant current medical or psychiatric condition
• Known hypersensitivity to propylene glycol

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06520, United States

RECRUITING

MeSH Terms

Conditions

Smoking; Tobacco Use Disorder

Interventions

Electronic Nicotine Delivery Systems; Nicotine; Menthol

Condition Hierarchy (Ancestors)

Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Cyclohexane Monoterpenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Monoterpenes; Terpenes; Lipids

Study Officials

• Lisa Fucito, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

• Krysten Bold, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa M. Fucito, PhD

CONTACT

203-200-1470; lisa.fucito@yale.edu

Krysten W Bold, PhD

CONTACT

203-974-7603; krysten.bold@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: To avoid randomized non-starters and potential bias due to differential early attrition from prior knowledge of group assignment, randomization will occur at the time of visit 0 when participants first receive tobacco products specific to their assigned condition, and neither the research assistant nor participant will know the assignment in advance. Researchers and participants will be blinded to the nicotine concentration.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 11, 2023
• Study Start: August 20, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: After study completion
• Access Criteria: Available upon request

Locations

US (1)