Switching to E-cigarettes in African-American Smokers

Sponsor

University of Kansas Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05703672

Collaborator

(none)

500

Enrollment

Locations

Arms

29.8

Anticipated Duration (Months)

250

Patients Per Site

8.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Smoking Reduction	Drug: Varenicline Tartrate Drug: Placebo Other: Electronic cigarette	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Mar 6, 2023

Anticipated Primary Completion Date :

Nov 30, 2024

Anticipated Study Completion Date :

Aug 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Varenicline and 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.	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. Other: Electronic cigarette Nicotine salt pod based e-cigarette in 5% nicotine
Placebo Comparator: Placebo and 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.	Drug: 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
Other: Open label electronic cigarette All participants will receive an initial 6-week supply of the study electronic cigarette.	Other: Electronic cigarette Nicotine salt pod based e-cigarette in 5% nicotine

Arm

Intervention/Treatment

Experimental: Varenicline and 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.

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.

Other: Electronic cigarette

Nicotine salt pod based e-cigarette in 5% nicotine

Placebo Comparator: Placebo and 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.

Drug: 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

Other: Open label electronic cigarette

All participants will receive an initial 6-week supply of the study electronic cigarette.

Other: Electronic cigarette

Nicotine salt pod based e-cigarette in 5% nicotine

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Swope Health Central	Kansas City	Missouri	United States	64130
2	University of Kansas Medical Center	Kansas City	Missouri	United States	64130

Sponsors and Collaborators

University of Kansas Medical Center

Investigators

Principal Investigator: Nicole Nollen, PhD, University of Kanas Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Kansas Medical Center

ClinicalTrials.gov Identifier:

NCT05703672

Other Study ID Numbers:

STUDY00146887

First Posted:

Jan 30, 2023

Last Update Posted:

Jan 30, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Varenicline

Study Results

No Results Posted as of Jan 30, 2023