Feasibility of Treatment for Vaping Cessation

NCT ID: NCT04317300

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2023-02-01

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.

Conditions

Vaping

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

E-cigarette users

Participants who are regular users of e-cigarettes will be treated with a 12 week course of varenicline for stopping vaping.

Group Type: EXPERIMENTAL

Varenicline

Intervention Type: DRUG

Dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 11 weeks of treatment.

brief behavioral therapy

Intervention Type: OTHER

brief behavioral therapy

Interventions

Varenicline

Dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 11 weeks of treatment.

Intervention Type: DRUG

brief behavioral therapy

brief behavioral therapy

Intervention Type: OTHER

Other Intervention Names

Chantix®

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Jon Ebbert

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jon Ebbert, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

19-011437

Identifier Type: -

Identifier Source: org_study_id