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Electronic Cigarette
Menthol-Flavored E-Cigarettes for Smoking Cessation
N/A
Recruiting
Led By Nicole Nollen, PhD
Research Sponsored by Nikki Nollen, PhD, MA
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 week 12
Awards & highlights
Study Summary
This trial will test if menthol-flavored e-cigarettes help adult menthol smokers switch from cigarettes to vaping more than tobacco-flavored ones.
Who is the study for?
This trial is for adult menthol smokers who smoke at least 5 cigarettes daily, have been smoking menthol cigarettes for over 6 months, and are interested in switching to e-cigarettes. They must be over 21 with a functioning phone. People can't join if they've used e-cigarettes or smoking cessation aids recently, have uncontrolled high blood pressure, are pregnant/breastfeeding, plan to move away soon, or want to quit smoking.Check my eligibility
What is being tested?
The study is testing whether using menthol-flavored or tobacco-flavored nicotine salt-based pod-system e-cigarettes helps adult menthol smokers switch from regular cigarettes to e-cigarettes more effectively.See study design
What are the potential side effects?
Potential side effects of using electronic cigarettes may include throat irritation, coughing, dry mouth and increased addiction potential due to nicotine content.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants who switch from cigarettes to electronic cigarettes at Week 12
Secondary outcome measures
Amount of e-liquid consumed
Spirometry
Trial Design
2Treatment groups
Active Control
Group I: Menthol Flavor Electronic CigaretteActive Control1 Intervention
400 adult cigarette smokers will receive 12 weeks of menthol-flavored electronic cigarettes.
Group II: Tobacco Flavor Electronic CigaretteActive Control1 Intervention
400 adult cigarette smokers will receive 12 weeks of tobacco-flavored electronic cigarettes.
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Who is running the clinical trial?
Nikki Nollen, PhD, MALead Sponsor
2 Previous Clinical Trials
521 Total Patients Enrolled
Nicole Nollen, PhDPrincipal InvestigatorUniversity of Kanas Medical Center
3 Previous Clinical Trials
964 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 21 years old or older.I have used medication to help me stop smoking in the last month.I have used tobacco products other than cigarettes in the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: Menthol Flavor Electronic Cigarette
- Group 2: Tobacco Flavor Electronic Cigarette
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are recruitment efforts still ongoing for this investigation?
"This experiment is currently accepting participants, as confirmed by the clinicaltrials.gov website where it was first uploaded on 8th November 2022 and its details last revised on 10th February 2023."
Answered by AI
How many participants are currently receiving treatment in this experiment?
"Indeed, the information available on clinicaltrials.gov confirms that this medical study is actively recruiting participants; it was first announced on November 8th 2022 and its most recent update occurred on February 10th 2023. The research requires 800 individuals from one medical centre to take part in the trial."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
Well, for the most part, I am a healthy 41. Year old woman with alot of spare time on my hands but I am a cigarette smoker. And I was just interested. A friend told me about the clinical trials.
PatientReceived 2+ prior treatments
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