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Menthol in E-cigarettes for Nicotine Addiction

Phase 1
Waitlist Available
Research Sponsored by Yale University
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 up to 5 weeks
Awards & highlights

Study Summary

This trial will study how different levels of nicotine and menthol in e-cigarettes affect smokers' behavior.

Who is the study for?
This trial is for adults over the age of 21 who can read and write, and currently smoke cigarettes. It's designed to explore how menthol in e-cigarettes affects their smoking habits.Check my eligibility
What is being tested?
The study is testing the effects of nicotine when used in e-cigarettes with menthol flavoring on people's smoking behaviors to understand if it influences tobacco use disorder or nicotine addiction.See study design
What are the potential side effects?
While specific side effects are not listed, typical reactions to nicotine include nausea, headache, dry mouth, dizziness, coughing or throat irritation from vaping.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Carbon monoxide
Plasma nicotine levels
cigarette craving
Secondary outcome measures
cigarette use
coolness
e-cigarette craving
+5 more
Other outcome measures
blood pressure
heart rate
pulse oximetry

Side effects data

From 2014 Phase 4 trial • 127 Patients • NCT01400243
65%
Any nonserious adverse event
22%
Itchiness at Patch Site
16%
Nausea
8%
Redness at patch site
5%
Headache
5%
Decreased appetite
2%
Lucid dreams
2%
Hot or sweating
2%
Lightheadedness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nicotine Patch
Placebo Patch

Trial Design

2Treatment groups
Experimental Treatment
Group I: tobacco flavorExperimental Treatment1 Intervention
Participants will receive 5% nicotine in an e-cigarette
Group II: menthol flavorExperimental Treatment1 Intervention
Participants will receive 5% nicotine in an e-cigarette
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine
2005
Completed Phase 4
~2980

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,847 Previous Clinical Trials
2,736,518 Total Patients Enrolled
4 Trials studying Nicotine Addiction
194 Patients Enrolled for Nicotine Addiction
National Institute on Drug Abuse (NIDA)NIH
2,464 Previous Clinical Trials
2,618,583 Total Patients Enrolled
15 Trials studying Nicotine Addiction
2,130 Patients Enrolled for Nicotine Addiction

Media Library

Menthol in E-cigarettes (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04521647 — Phase 1
Nicotine Addiction Research Study Groups: menthol flavor, tobacco flavor
Nicotine Addiction Clinical Trial 2023: Menthol in E-cigarettes Highlights & Side Effects. Trial Name: NCT04521647 — Phase 1
Menthol in E-cigarettes (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04521647 — Phase 1

Frequently Asked Questions

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

What is the goal of this research project?

"This trial's primary purpose is to evaluate the effects of carbon monoxide during a 3-week period. Secondary metrics will include nicotine withdrawal, e-cigarette use, and coolness as assessed through Drug Effect Questionnaire (0–100mm scale), Time Line Follow Back, and Labeled Magnitude Scale (-100 – 100)."

Answered by AI

What deleterious effects can Nicotine have on one's health?

"With limited evidence supporting its safety and efficacy, nicotine was assigned a rating of 1."

Answered by AI

What other scientific investigations have been performed using Nicotine as the focus?

"At present, there are 71 ongoing trials researching Nicotine with 5 in their terminal phase. Most studies take place in Green Bay, Wisconsin but a total of 204 sites are conducting these clinical tests."

Answered by AI

Does this clinical research accept participants under the age of 30?

"For this medical study, participants must be younger than 65 and older than the age of majority."

Answered by AI

How do I become an eligible participant for this clinical research?

"Nicotine dependents aged 21-65 are eligible to join this study, the goal of which is to enroll 85 participants in total."

Answered by AI

Is participation still being welcomed for this research project?

"Per information on clinicaltrials.gov, this trial is still recruiting patients. It was initially published on November 1st 2020 and its details were updated for the last time on April 11th 2022."

Answered by AI

How many participants have been included in this research project?

"Yes, according to clinicaltrials.gov, this investigation commenced recruitment on the 1st November 2020 and is still in progress as of 11th April 2022. The study requires 85 participants from 2 healthcare facilities."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Effects of Menthol in E-cigarettes on Smoking Behaviors
Asti Jackson 2022. "Effects of Menthol in E-cigarettes on Smoking Behaviors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04521647.
~3 spots leftby Apr 2025
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