Feasibility of Treatment for Vaping Cessation (VAPEscape)

Mayo Clinic

Status and phase

Withdrawn

Early Phase 1

Conditions

Vaping

Treatments

Drug: Varenicline

Other: brief behavioral therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04317300

19-011437

Details and patient eligibility

About

Researchers are gathering information on the feasibility of treating e-cigarette users with 12-weeks of varenicline (Chantix®) in assisting with stopping the use of e-cigarettes.

Full description

Because the process of developing nicotine dependence and the reinforcing mechanisms of nicotine delivered in high concentrations are similar between tobacco cigarettes and newer generation electronic cigarettes, the investigators hypothesize that evidence based treatment approaches used in treating tobacco dependence should be effective in treating dependence on electronic cigarettes. Since there is no existing evidence base for treatment of electronic cigarette dependence, preliminary evidence is needed from feasibility and open label studies to guide in the development of future randomized clinical trials. In this study, vaping participants will be treated with a 12 week course of varenicline as well as have nicotine dependence counseling through a certified tobacco treatment specialist followed up 12 weeks post end of medication.

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

≥18 years and ≤65 years of age;
No use of tobacco in any form (except E-cigarettes) in the past 3 months;
currently using e-cigarettes

Exclusion criteria

Current moderate or severe depression
Use of any treatments for tobacco dependence within the past 30 days;
Recent history (past 3 months) of abuse of, or dependence on, a substance other than nicotine;
Women who are pregnant or lactating, or who are of childbearing potential and are likely to become pregnant during the medication phase, or a male who is able to father a child, and are not willing to use a reliable form of contraception,
Subject describes having a medical history of: a) unstable angina; b) myocardial infarction within the past 3 months; c) coronary angioplasty; or d) an untreated cardiac dysrhythmia;
Subject currently has cancer [excluding non-melanoma skin cancer] not in remission;
Known allergy to varenicline;
Subject has a medical condition deemed by the investigators to be exclusionary to the study.