Feasibility of Treatment for Vaping Cessation

Early Phase 1

Withdrawn

• Conditions: Vaping
• Interventions: Drug: Varenicline; Other: brief behavioral therapy

• Registration Number: NCT04317300
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-02-14
• Study First Submitted QC: 2020-03-20
• Study First Posted: 2020-03-23
• Status Verified: 2023-02
• Study Start: 2023-02-01
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-01
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
E-cigarette users	brief behavioral therapy	Participants who are regular users of e-cigarettes will be treated with a 12 week course of varenicline for stopping vaping.
E-cigarette users	Varenicline	Participants who are regular users of e-cigarettes will be treated with a 12 week course of varenicline for stopping vaping.

Primary Outcome Measures

Name	Time	Method
Rate of e-cigarette abstinence after 12 weeks of treatment with varenicline plus brief behavioral therapy as an aid to stop vaping	12 weeks	The rate of self reported e-cigarette abstinence verified biochemically with nicotine and nicotine metabolites in urine will be assessed at the end of a 12-week course of varenicline plus brief behavioral therapy.