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e-cigarette for Tobacco Use

N/A

Waitlist Available

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 0 through day 35

Awards & highlights

Study Summary

This trial is testing whether e-cigarettes can help smokers who have already tried and failed to quit with traditional methods. Current smokers who failed to quit with FDA-approved pharmacotherapy within the past year will be randomly assigned to either 1) switch completely to e-cigarettes, or 2) try to quit again using pharmacotherapy. The trial will evaluate smoking reduction and biochemically-confirmed abstinence from cigarette smoking at 4-weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0 through day 35

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 0 through day 35

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 through day 35 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of participants who have biochemically-confirmed abstinence from cigarette smoking

Percentage of participants who report daily use of e-cigarettes or NRT and no cigarette use

Side effects data

From 2021 Phase 2 & 3 trial • 25 Patients • NCT04210180

40%

Nausea

24%

Headache

20%

Cough

16%

Insomnia

12%

Nightmares/ Vivid Dreams

Vomiting

Agitation/Anxiety

Sore Throat

Constipation

Allergic Reaction to lidocaine

100%

80%

60%

40%

20%

Study treatment Arm

Varenicline Plus E-cigarette

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Switch GroupExperimental Treatment1 Intervention

Participants in the Switch group will receive a 5-week supply of e-cigarettes.

Group II: Meds GroupActive Control1 Intervention

Participants in the Meds Group will receive a 5-week supply of combination nicotine replacement therapy (transdermal nicotine patch and short-acting nicotine lozenge).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

e-cigarette

2019

Completed Phase 3

~1890

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Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor

932 Previous Clinical Trials

7,394,230 Total Patients Enrolled

9 Trials studying Tobacco Use

42,337 Patients Enrolled for Tobacco Use

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research team seeking new applicants for this investigation?

"Going by the information on clinicaltrials.gov, this trial is recruiting participants at this time. The study was published in August of 2022 and has had its details recently updated in November of that same year."

Answered by AI

What is the maximum capacity of participants for this investigation?

"Affirmative. Information available on clinicaltrials.gov reveals that this research endeavour is actively seeking participants, having been first published on August 1st 2022 and last updated November 1st of the same year. The study necessitates enrolment from 30 patients at a single facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Quit or Switch: E-cigarette Study

Tracy Smith 2022. "Quit or Switch: E-cigarette Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05525078.