RECRUITING

Switching to E-cigarettes in Smokers Not Interested in Quitting

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 objectives of this application are to 1) compare short- and long-term harm reduction and abuse liability potential of a nicotine salt pod-based electronic cigarettes (EC) in adult (AA) exclusive EC, dual cig-EC, and exclusive cig users, 2) characterize factors that predict who switches fully, partially, or not at all, and 3) examine if harm reduction can be further enhanced by treating dual users with varenicline (VAR) to eliminate cigarette smoking.

Official Title

4th Generation E-cigarettes: Reducing Harm and Quitting Combustible Cigarettes in Dual Users

Quick Facts

Study Start:2023-07-17
Study Completion:2027-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05703672

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:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥ 21 years of age
  2. * Smoke \>5 cigarettes per day
  3. * Smoked cigarettes for \> 6 months
  4. * Verified smoker (CO \> 5 ppm)
  5. * Functioning telephone
  6. * Interested in switching to EC
  7. * Willing to take varenicline and complete all study visits
  1. * Interested in quitting smoking
  2. * Use of smoking cessation pharmacotherapy in the month prior to enrollment
  3. * Use of other tobacco products in past 30 days (i.e., cigarillos, cigars, hookah, smokeless tobacco, pipes)
  4. * EC use on \> 4 of the past 30 days
  5. * Uncontrolled hypertension: BP \> 180 (systolic) or \> 105 (diastolic)
  6. * Heart-related event in the past 30 days
  7. * Medical contraindications to VAR: unstable cardiac condition (e.g., unstable angina or AMI) cardiac event, or stroke in the past 4 weeks; renal impairment; history of clinically significant allergic reactions; history of epilepsy or seizure disorder; hospitalized for psychiatric issue in past 30 days; active suicidal ideation
  8. * Pregnant, contemplating getting pregnant, or breastfeeding
  9. * Plans to move from Kansas City metro area during the treatment and follow-up phase
  10. * Another household member enrolled in the study

Contacts and Locations

Study Contact

Tricia Snow, MPH
CONTACT
816-398-8960
psnow@kumc.edu

Principal Investigator

Nicole Nollen, PhD
PRINCIPAL_INVESTIGATOR
University of Kanas Medical Center

Study Locations (Sites)

Swope Health Central
Kansas City, Missouri, 64130
United States
University of Kansas Medical Center
Kansas City, Missouri, 64130
United States

Collaborators and Investigators

Sponsor: University of Kansas Medical Center

  • Nicole Nollen, PhD, PRINCIPAL_INVESTIGATOR, University of Kanas Medical Center

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 Date2023-07-17
Study Completion Date2027-02-28

Study Record Updates

Study Start Date2023-07-17
Study Completion Date2027-02-28

Terms related to this study

Additional Relevant MeSH Terms

  • Smoking Reduction