RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-08-20
Study Completion:2028-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06077240

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 21+ years old
  2. * English literate
  3. * Currently smoking cigarettes, biochemically confirmed
  4. * Not planning a smoking cessation attempt or to use smoking cessation pharmacotherapies (NRT, bupropion, varenicline) in the next month.
  1. * Currently using any smoking cessation services and/or pharmacotherapies
  2. * Currently pregnant or breastfeeding
  3. * Significant current medical or psychiatric condition
  4. * Known hypersensitivity to propylene glycol.

Contacts and Locations

Study Contact

Lisa M. Fucito, PhD
CONTACT
203-200-1470
lisa.fucito@yale.edu
Krysten W Bold, PhD
CONTACT
203-974-7603
krysten.bold@yale.edu

Principal Investigator

Lisa Fucito, PhD
PRINCIPAL_INVESTIGATOR
Yale University
Krysten Bold, PhD
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

Yale University
New Haven, Connecticut, 06520
United States

Collaborators and Investigators

Sponsor: Yale University

  • Lisa Fucito, PhD, PRINCIPAL_INVESTIGATOR, Yale University
  • Krysten Bold, PhD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-20
Study Completion Date2028-04-01

Study Record Updates

Study Start Date2024-08-20
Study Completion Date2028-04-01

Terms related to this study

Additional Relevant MeSH Terms

  • Smoking
  • Smoking Behaviors
  • Nicotine Dependence