Vagal Nerve Stimulation + Nicotine Replacement for Smoking Cessation

SF
SS
Overseen BySara Seegmiller, RN
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: Mayo Clinic
Must be taking: Nicotine replacement
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to provide preliminary evidence for the efficacy of 12 weeks of vagal nerve stimulation (VNS) and nicotine replacement therapy (NRT) for increasing smoking abstinence rates.

Who Is on the Research Team?

RH

Ryan Hurt, MD, PhD

Principal Investigator

Mayo Clinic

IT

Ivana T Croghan, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

Inclusion Criteria

I am motivated to quit smoking.
Currently smoking at least 10 cigarettes/day
I am able to take part in all study activities.
See 3 more

Exclusion Criteria

I currently have moderate or severe depression based on my PHQ-9 score.
Patients with a known allergy to nicotine patches or varenicline
Patients who are or have used an investigational drug within the past 30 days
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nicotine replacement therapy and vagal nerve stimulation for smoking cessation

12 weeks
Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for smoking abstinence and safety after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Nicotine Replacement Therapy
  • Vagal Nerve Stimulation

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Vagal Nerve Stimulator and Nicotine Replacement PatchesExperimental Treatment1 Intervention
Group II: Nicotine Replacement PatchesActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+