Feasibility of Treatment for Vaping Cessation

Vaping Clinical Trial

— VAPEscape  

Official title:

The Feasibility of Treatment for Vaping Cessation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04317300
• Other study ID #: 19-011437
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: February 1, 2023
• Est. completion date: February 1, 2023

Study information

• Verified date: February 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vaping

Intervention

Drug:
• 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.

Other:
• brief behavioral therapy
brief behavioral therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of e-cigarette abstinence after 12 weeks of treatment with varenicline plus brief behavioral therapy as an aid to stop vaping	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.	12 weeks

External Links

•   Mayo Clinic Clinical Trials