Switching to E-cigarettes in African-American Smokers

Phase 3

Recruiting

• Conditions: Smoking Reduction
• Interventions: Other: Electronic cigarette; Drug: Placebo; Drug: Varenicline Tartrate

• Registration Number: NCT05703672
• Lead Sponsor: University of Kansas Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-01-19
• Study First Submitted QC: 2023-01-19
• Study First Posted: 2023-01-30
• Study Start: 2023-07-17
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-20
• Primary Completion: 2026-12-30
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open label electronic cigarette	Electronic cigarette	All participants will receive an initial 6-week supply of the study electronic cigarette.
Varenicline and electronic cigarette	Electronic cigarette	At the end of the 6-week open label phase, dual users of cigarettes and e-cigarettes will receive 1mg varenicline to take twice daily for 12 weeks. They will also receive an additional 12 weeks of the nicotine salt-based pod system e-cigarette.
Placebo and electronic cigarette	Placebo	At the end of the 6-week open label phase, dual users of cigarettes and e-cigarettes will receive placebo pills to take twice daily for 12 weeks. They will also receive an additional 12 weeks of the nicotine salt-based pod system e-cigarette.
Varenicline and electronic cigarette	Varenicline Tartrate	At the end of the 6-week open label phase, dual users of cigarettes and e-cigarettes will receive 1mg varenicline to take twice daily for 12 weeks. They will also receive an additional 12 weeks of the nicotine salt-based pod system e-cigarette.
Placebo and electronic cigarette	Electronic cigarette	At the end of the 6-week open label phase, dual users of cigarettes and e-cigarettes will receive placebo pills to take twice daily for 12 weeks. They will also receive an additional 12 weeks of the nicotine salt-based pod system e-cigarette.

Primary Outcome Measures

Name	Time	Method
Reduction in toxicant exposure as measured by NNAL (4- (methylnitrosamino)-1-(3-pyridyl)-1-butanol) .	Week 6	Reduction in toxicant exposure as measured by NNAL excretion from baseline to week 6.

Secondary Outcome Measures

Name	Time	Method
Carbon Monoxide (CO) verified 7-day point prevalence abstinence from cigarettes	Week 12 post randomization	CO verified 7-day point prevalence abstinence from cigarettes at week 12 post randomization.

Trial Locations

Locations (2)

Swope Health Central; 🇺🇸 Kansas City, Missouri, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Missouri, United States