Varenicline for Vaping

Recruiting at 1 trial location

Overseen By Michael Fatigate, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Yale University

Disqualifiers: Other tobacco, Varenicline contraindications, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 29

Duration: 12 weeks

326 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a medication called varenicline helps people quit using e-cigarettes. Participants will receive either varenicline, a pill that may ease quitting, or a placebo, a look-alike pill with no active ingredients. The trial seeks individuals who use e-cigarettes with nicotine daily and reside in Connecticut or South Carolina. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are currently being treated for tobacco cessation, you may not be eligible to participate.

Is there any evidence suggesting that varenicline is likely to be safe for humans?

Research shows that varenicline is generally easy to use without problems. A review of different studies found that it more than doubled the chances of quitting vaping compared to other methods. These studies examined the safety and effectiveness of varenicline.

One study showed that young adults using varenicline successfully quit vaping without switching to regular cigarettes, and they did not report any major safety issues. This suggests that varenicline is safe for those wanting to quit vaping.

Although limited research exists specifically on using varenicline to stop vaping, it is approved for quitting smoking. This approval suggests it is likely safe. However, more research is needed to confirm its safety specifically for vaping. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for quitting e-cigarettes?

Most treatments for vaping addiction focus on nicotine replacement or behavioral therapies. But Varenicline works differently by targeting nicotine receptors in the brain, reducing cravings and withdrawal symptoms. This unique mechanism of action sets it apart from standard options. Researchers are excited because Varenicline could offer a more effective way to help people quit vaping, potentially providing quicker relief from cravings compared to traditional methods.

What evidence suggests that varenicline might be an effective treatment for quitting e-cigarettes?

Research has shown that varenicline, which participants in this trial may receive, can help people quit vaping. In one study, 51% of those using varenicline stopped vaping, compared to just 14% who took a placebo (a pill with no active medicine). Another study found that 28% of young adults quit vaping with varenicline, while only 7% quit with a placebo. Most people tolerate varenicline well, but some might experience nausea or vivid dreams. Overall, these studies suggest that varenicline significantly increases the chances of successfully quitting e-cigarettes. ^{3 5 6 7 8}

Who Is on the Research Team?

Lisa Fucito, PhD

Principal Investigator

Yale University

Benjamin Toll, PhD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for adults who regularly use e-cigarettes and want to quit. Specific eligibility details are not provided, but typically participants must be in good health and meet certain criteria set by the study.

Inclusion Criteria

Report daily use of an e-cigarette containing nicotine

Live in Connecticut or South Carolina

Exclusion Criteria

Regular use of other tobacco products besides e-cigarettes

I am currently receiving treatment to stop smoking.

Lack proficiency in English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 12 weeks of varenicline or placebo, with brief cessation advice and self-management resources

12 weeks

Research assessments every 3 weeks

Follow-up

Participants are monitored for e-cigarette abstinence and health biomarkers

14 weeks

Final follow-up visit at week 26

What Are the Treatments Tested in This Trial?

Interventions

• Varenicline

Trial Overview The trial is testing if Varenicline, taken twice a day (1mg BID), helps people stop using e-cigarettes compared to a placebo. It's a randomized study, meaning participants are put into the Varenicline or placebo group by chance.

How Is the Trial Designed?

Group I: Varenicline Experimental Treatment 1 Intervention

Participants will randomly be assigned to 12-weeks of varenicline (titrated to 2mg daily) plus brief cessation advice with a counselor and self-management resources.

Group II: Placebo Placebo Group 1 Intervention

Participants will randomly be assigned to 12-weeks of matching placebo plus brief cessation advice with a counselor and self-management resources.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40266580/

Varenicline for Youth Nicotine Vaping Cessation - PubMed - NIH For varenicline and placebo, continuous abstinence rates were 51% vs 14% during weeks 9 through 12 (adjusted odds ratio [aOR], 6.5 [95% CI, 3.0- ...

2. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2833137

Varenicline for Youth Nicotine Vaping Cessation Varenicline, combined with behavioral counseling, increased vaping abstinence in youth who vape nicotine and do not regularly smoke tobacco.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871625003370

Efficacy and safety of varenicline for electronic cigarette ... Varenicline improved vaping cessation rates compared to placebo and was generally well tolerated, despite a higher incidence of nausea and vivid dreams.

4. hollingscancercenter.musc.edu hollingscancercenter.musc.edu/news/archive/2025/08/22/new-study-aims-to-help-people-quit-vaping

New study aims to help people quit vaping In that randomized study, significantly more participants who received varenicline successfully quit vaping by the end of treatment, compared ...

5. massgeneralbrigham.org massgeneralbrigham.org/en/about/newsroom/press-releases/smoking-cessation-drug-helps-young-adults-quit-vaping

Varenicline Helps Young Adults Quit Vaping At 24 weeks, 28% of varenicline users had stopped vaping, compared to 7% of placebo users and 4% of text-only users. These findings demonstrate ...

6. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2820176

Electronic Cigarettes vs Varenicline for Smoking Cessation ... This randomized clinical trial found that varenicline and nicotine-containing ECs were both effective in helping individuals in quitting smoking conventional ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10321010/

Varenicline and counseling for vaping cessation The efficacy and safety of varenicline for vaping cessation has not been studied and rigorous research is required to advance best practice and ...

8. medicine.yale.edu medicine.yale.edu/news-article/first-us-trial-of-varenicline-for-e-cigarette-cessation-shows-positive-results/

First U.S. Trial of Varenicline for E-cigarette Cessation Shows ... The first U.S. trial of varenicline for e-cigarette cessation shows promising results and warrants larger-scale trials, the researchers say.