NCT04317300

Feasibility of Treatment for Vaping Cessation

The Feasibility of Treatment for Vaping Cessation

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-02-01
• Primary completion: 2023-02-01
• Completion: 2023-02-01
• First posted: 2020-03-23
• Last updated: 2023-02-08

Regulatory

• FDA-regulated drug study