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Varenicline for Improving Smoking Cessation in Adults who use Electronic Cigarettes
Trial Status: active
This phase II trial evaluates whether varenicline improves smoking cessation in adults who use electronic (e)-cigarettes. E-cigarettes are battery-operated devices that heat and aerosolize a liquid solution that contains nicotine, flavors, and other chemicals. While e-cigarettes were introduced as a potential harm reduction option for adults who smoke traditional cigarettes and may promote smoking cessation, they are not harm free. Varenicline is a Food and Drug Administration-approved cigarette smoking cessation medication. It works by suppressing nicotine withdrawal symptoms and reducing the brain's reward effects associated with nicotine exposure. There is limited research addressing pharmacotherapies like varenicline as treatment options for e-cigarette use. Varenicline may help e-cigarette users quit and may also reduce their risk of relapsing.
Inclusion Criteria
Are age 18+
Report daily use of an e-cigarette containing nicotine (defined as use for at least 25 days out of the past month) for at least 6 months
Are willing to set a quit date and maintain e-cigarette abstinence
Live in Connecticut or South Carolina
Exclusion Criteria
Report use of combustible tobacco (including cigarettes, cigarillos, etc.) or non-combustible nicotine products (i.e., pouches, smokeless tobacco) > 1 time per week in the past 3 months or any combustible use in the past month
Have medical contraindications for varenicline use (e.g., cardiac or renal disease, seizure disorders and other risks)
Report current use of smoking cessation medications (varenicline, bupropion, nicotine replacement therapy)
Have another household member enrolled in the study
Lack proficiency in English
Have a current, serious uncontrolled medical or mental health condition based on evaluation by research staff and review by study physicians, Drs. Baldassarri and Gray, that would increase risk of severe adverse events and/or interfere with study participation. These conditions would include: (1) any cardiac conditions that required a hospitalization or intensive treatment on an outpatient basis in the past year such as myocardial infarction, coronary artery disease, unstable angina, congestive heart failure, or tachyarrhythmias (including rapid atrial fibrillation, ventricular tachycardia, or ventricular fibrillation); (2) experiencing a seizure in the past year, as well as individuals who are currently prescribed medications known to reduce seizure threshold; (3) any current, serious uncontrolled medical or psychiatric condition that required a hospitalization or intensive treatment on an outpatient basis in the past year (such as renal disease); and/or (4) endorsing current suicidal ideation on a standard suicide risk behavior screener
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07040566.
I. To evaluate the efficacy of varenicline tartrate (varenicline) compared to placebo on nicotine e-cigarette use in adults who report exclusive use.
SECONDARY OBJECTIVE:
I. To examine factors that predict nicotine e-cigarette cessation or modify response to varenicline for e-cigarette cessation.
EXPLORATORY OBJECTIVE:
I. To examine the effect of varenicline compared to placebo on cancer-related biomarkers in adults who report exclusive nicotine e-cigarette use.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants attend a counseling session over 20 minutes to discuss medication guidelines, cessation advice, and instructions for starting medication and setting a quit date within 1-2 weeks and also receive a guided self-help booklet. Participants receive varenicline orally (PO) once daily (QD) on days 1-3 and PO twice daily (BID) on days 4+. Treatment continues for 12 weeks in the absence of unacceptable toxicity. Participants also undergo collection of blood samples throughout the study.
ARM II: Participants attend a counseling session over 20 minutes to discuss medication guidelines, cessation advice, and instructions for starting medication and setting a quit date within 1-2 weeks and also receive a guided self-help booklet. Participants receive placebo PO QD on days 1-3 and PO BID on days 4+. Treatment continues for 12 weeks in the absence of unacceptable toxicity. Participants also undergo collection of blood samples throughout the study.
After completion of study intervention, participants are followed up in week 26.
