A Study to Evaluate the Feasibility of Varenicline Treatment for Vaping Cessation

Overview

About this study

The purpose of this study is to evaluate the feasibility of treating users of E-cigarettes with a 12-week course of varenicline to stop vaping.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • ≥ 18 years and ≤ 65 years of age.
  • No use of tobacco in any form (except E-cigarettes) in the past 3 months.
  • Expired air carbon monoxide < 8 ppm.
  • Used at least 1 disposable e-cigarette or 1 refillable unit (tank, cartomizer, pod) per week for the past 3 months.
  • Motivated to stop using e-cigarettes.
  • Able to participate fully in all aspects of the study.
  • Understand and sign the study informed consent.
  • Subject is in good health as determined by the clinical investigators.

Exclusion Criteria

  • Current moderate or severe depression as assessed by a score of ≥ 16 on the Center for Epidemiologic Studies-Depression (CES-D).
  • A lifetime history of psychosis, bipolar disorder or schizophrenia.
  • Use of anti-psychotic medication within the past 30 days;
  • Use of any treatments for tobacco dependence within the past 30 days.
  • Use of an investigational drug within the past 30 days.
  • Recent history (past 3 months) of abuse of, or dependence on, a substance other than nicotine including: heavy alcohol consumption (If male, drinking > 14 alcoholic beverages per week for the past month and if female, drinking > 7 alcoholic beverages per week for past month); use of cocaine, heroin, club drugs (i.e., MDMA/“ecstasy”); methamphetamine, or hallucinogens (e.g., LSD) at any time during the past 3 months; and use of marijuana CBD) on a weekly basis for the past 3 months.
  • 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, will also be excluded (reliable forms of contraception include oral contraception, diaphragm, condom (with spermicide), injections, intrauterine device, surgical sterilization, and abstinence).
  • Subject describes having a medical history of:
    • unstable angina;
    • myocardial infarction within the past 3 months; 
    • coronary angioplasty; or 
    • 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.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

J Taylor Hays, M.D.

Contact us for the latest status

Contact information:

Shawn Fokken CCRP

(507) 293-2740

Fokken.Shawn@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20480309

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