Switching to E-cigarettes in African-American Smokers

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Smoking Reduction

Intervention / Treatment
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* Drug: Varenicline Tartrate
* Drug: Placebo
* Other: Electronic cigarette


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |