Switching to E-cigarettes in African-American Smokers

Smoking Reduction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05703672
• Other study ID #: STUDY00146887
• Status: Recruiting
• Phase: Phase 3
• Start date: July 17, 2023
• Est. completion date: February 1, 2026

Study information

• Verified date: January 2024
• Source: University of Kansas Medical Center
• Contact: Tricia Snow, MPH
• Phone: 816-398-8960
• Email: psnow[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 African American (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.

Description:

African American (AA) cigarette smokers (n=500) who are interested in switching to a nicotine salt-based electronic cigarette (EC) and are not established EC users will receive a 6-week supply of the EC and assistance with switching. After six weeks, those that are dual users (n=221) will receive an additional 12 weeks of the EC and be randomized in a 2:1 fashion to receive 12 weeks of varenicline (VAR) or placebo (PBO) and additional counseling to support a complete switch. Follow-up for all participants will continue through week 52. The primary outcome is change in the potent lung carcinogen, NNAL, between exclusive EC, dual cig-EC, and exclusive cig users at week 6.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: February 1, 2026
• Est. primary completion date: August 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• African American
• = 21 years of age
• Smoke >5 cigarettes per day
• Smoked cigarettes for > 6 months
• Verified smoker (CO > 5 ppm)
• Functioning telephone
• Interested in switching to EC
• Willing to take varenicline and complete all study visits

Exclusion Criteria:

• Interested in quitting smoking
• Use of smoking cessation pharmacotherapy in the month prior to enrollment
• Use of other tobacco products in past 30 days (i.e., cigarillos, cigars, hookah, smokeless tobacco, pipes)
• EC use on > 4 of the past 30 days
• Uncontrolled hypertension: BP > 180 (systolic) or > 105 (diastolic)
• Heart-related event in the past 30 days
• 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
• Pregnant, contemplating getting pregnant, or breastfeeding
• Plans to move from Kansas City metro area during the treatment and follow-up phase
• Another household member enrolled in the study

Related Conditions & MeSH terms

• Smoking Reduction

Intervention

Drug:
• Varenicline Tartrate
0.5 mg once daily for days 1-3, 0.5mg twice daily for days 4-7 and 1.0 mg twice daily from day 8 through week 12.
• Placebo
One pill (white) once daily for days 1-3, one pill (white) twice daily for days 4-7 and one pill (blue) twice daily from day 8 through week 12.

Other:
• Electronic cigarette
Nicotine salt pod based e-cigarette in 5% nicotine

Locations

Country	Name	City	State
United States	Swope Health Central	Kansas City	Missouri
United States	University of Kansas Medical Center	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in toxicant exposure as measured by NNAL (4- (methylnitrosamino)-1-(3-pyridyl)-1-butanol) .	Reduction in toxicant exposure as measured by NNAL excretion from baseline to week 6.	Week 6
Secondary	Carbon Monoxide (CO) verified 7-day point prevalence abstinence from cigarettes	CO verified 7-day point prevalence abstinence from cigarettes at week 12 post randomization.	Week 12 post randomization