Nicotine Salt-Based Pod System Electronic Cigarette and Counseling With or Without Varenicline and to Facilitate Cigarette Smoking Cessation in African American Smokers

Status: active

This trial tests how well using nicotine salt based pod system (NSPS) electronic cigarette (EC) and counseling with or without varenicline works to facilitate cigarette smoking cessation among African American smokers. Smoking is the biggest cause of disease and death that could be avoided in the United States. African Americans have higher rates of tobacco-related disease than the general population. Quitting all nicotine products is the best way to reduce harms from cigarettes but many smokers aren’t ready or are unable to quit. For these individuals, switching from cigarettes to electronic cigarettes may be a safer alternative to ongoing, regular cigarette use. NIPS contains high nicotine concentrations with rapid nicotine delivery but fewer tobacco toxicants. Varenicline is a drug used to help people stop smoking by acting the same way nicotine acts in the brain. It is a type of nicotine receptor partial agonist. Using the NSPS EC and counseling with or without varenicline may encourage cigarette smoking cessation and lower the amount of tobacco-related chemicals that might cause disease.in African American smokers.

Inclusion Criteria

Non-Hispanic African American
≥ 21 years of age
Smoke ≥ 5 cigarettes per day (CPD)
Daily cigarette smoker
Smoked cigarettes for ≥ 6 months
Verified smoker (carbon monoxide [CO] ≥ 5 ppm)
Functioning telephone
Interested in switching to EC
Willing to take VAR and complete all study visits

Exclusion Criteria

Interested in quitting smoking
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: Blood pressure (BP) ≥ 180 (systolic) or ≥ 105 (diastolic)
Onset of cough, fever, nausea, vomiting, gastrointestinal (GI) symptoms in past 2 weeks
Medical contraindications to VAR: unstable cardiac condition (e.g., unstable angina or acute myocardial infarction [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
Use of smoking cessation pharmacotherapy in the month prior to enrollment
Pregnant, contemplating getting pregnant, or breastfeeding
Plans to move from Kansas City (KC) during the treatment and follow-up phase
Another household member enrolled in the study

PRIMARY OBJECTIVES:

I. Compare the short-term harm reduction potential of a 6-week trial of a nicotine salt-based pod system electronic cigarette (NSPS) in African American smokers and factors that predict e-cigarette use (EC) pattern.

II. Compare long-term harm reduction through one year.

III. Compare the impact of varenicline (VAR) (versus placebo [PBO]) among dual users.

OUTLINE:

PHASE I: Participants receive NSPS EC to be smoked as desired for 6 weeks. Participants attend 30 minute counseling sessions consisting of education on importance of switching exclusively to EC, motivation enhancement and goal planning at weeks 0, 2, and 4.

PHASE II: After completing phase I, participants who are using EC and cigarettes are randomized to arm I or arm II. Participants who are exclusive EC users, exclusive cigarette users or who are not using EC or cigarettes are assigned to arm III.

ARM I: Participants receive NSPS EC to be smoked as desired for 12 weeks. Participants receive varenicline orally (PO) once daily (QD) on days 1-3 and twice daily (BID) on day 4 through week 12. Patients attend 30 minute counseling sessions at weeks 6, 8, 12, and 18

ARM II: Participants receive NSPS EC to be smoked as desired for 12 weeks. Participants receive placebo PO QD on days 1-3 and BID on day 4 through week 12. Patients attend 30 minute counseling sessions at weeks 6, 8, 12, and 18.

ARM III: Participants receive NSPS EC to be smoked as desired for 18 weeks and continue to attend 30 minute counseling sessions at weeks 6, 8,12 and 18.

After completion of study intervention, participants are followed up at month 6, 8,10 and 12.

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Nicotine Salt-Based Pod System Electronic Cigarette and Counseling With or Without Varenicline and to Facilitate Cigarette Smoking Cessation in African American Smokers

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