Switching to E-cigarettes in African-American Smokers
Purpose
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
- Smoking Reduction
Eligibility
- Eligible Ages
- Over 21 Years
- Eligible Genders
- 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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
|
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. |
|
|
Other Open label electronic cigarette |
All participants will receive an initial 6-week supply of the study electronic cigarette. |
|
Recruiting Locations
Kansas City, Missouri 64130
More Details
- Status
- Recruiting
- Sponsor
- University of Kansas Medical Center
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.