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

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

Interventions

BEHAVIORAL

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

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

BEHAVIORAL

E-cigarette with 2.4% Nicotine with Tobacco Flavor Only

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

BEHAVIORAL

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

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

BEHAVIORAL

E-cigarette with 5% Nicotine with Tobacco Flavor Only

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

BEHAVIORAL

Tobacco Pouches with 3mg Nicotine with Menthol and Tobacco Flavors

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

BEHAVIORAL

Tobacco Pouches with 3mg Nicotine with Tobacco Flavor Only

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

BEHAVIORAL

Tobacco Pouches with 6mg Nicotine with Menthol and Tobacco Flavors

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

BEHAVIORAL

Tobacco Pouches with 6mg Nicotine with Tobacco Flavor Only

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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Yale University

  lead OTHER

Principal Investigators

• Lisa Fucito, PhD · Yale University

• Krysten Bold, PhD · Yale University

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-20

Primary Completion

2028-04-01

Completion

2028-04-01

Countries

• United States

Study Locations