NCT05541497

Varenicline for Treatment of E-cigarette Dependence

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Varenicline is used to treat tobacco use dependence. It helps reduce cravings for tobacco use and decreases the pleasurable effects of cigarettes and other tobacco products. Varenicline has been proven to reduce the desire to smoke cigarettes. This study aims to test whether it shows a similar benefit for individuals who vape and are interested in quitting.

Detailed description

Varenicline is a highly efficacious FDA-approved smoking cessation pharmacotherapy. The aim of this study is to examine the effectiveness of varenicline for e-cigarette cessation medication for mono- e-cigarette use in combination with a minimal, self-guided behavior change booklet. This booklet will include general tips for e-cigarettes cessation and information about the free web-based e-cigarette cessation program sponsored by The Truth Initiative and Mayo called "This is Quitting". This study will have an 8-week treatment period and a 4-week follow-up phase. Participants will be randomized to receive an 8-week supply of varenicline or matching placebo (gel capsule filled with cellulose powder) in combination with the self-change booklet. The investigators hypothesize that participants who receive varenicline will have higher rates of e-cigarette cessation.

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
DRUG	Varenicline Tartrate	Days 1-3: 0.5mg study pill once per day, Days 4-7: 0.5mg study pill twice per day, Weeks 2-8: 1mg study pill twice per day
DRUG	Placebo	Days 1-3: 0.5mg pill once per day, Days 4-7: 0.5mg pill twice per day, Weeks 2-8: 1mg pill twice per day

Timeline

• Start date: 2022-11-04
• Primary completion: 2023-09-01
• Completion: 2023-09-01
• First posted: 2022-09-15
• Last updated: 2024-12-02
• Results posted: 2024-12-02

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study