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Flavor

E-Cigarette Flavors for Vaping-Related Respiratory Symptoms (CRoFT Trial)

N/A

Recruiting

Led By Maciej Goniewicz, PhD

Research Sponsored by Roswell Park Cancer Institute

Eligibility Criteria Checklist

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

Must have

ENDS users who have been using ENDS daily, regularly for the past 6 months (self-reported)

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 90 days

Awards & highlights

CRoFT Trial Summary

This trial is testing if people who switch from flavored e-cigarettes to either tobacco-flavored e-cigarettes or nicotine pouches have different respiratory symptoms.

Who is the study for?

This trial is for adults who've been using electronic nicotine delivery systems (ENDS) with banned flavors like fruit or candy daily for the past 6 months and don't plan to quit soon. They shouldn't have smoked tobacco or used smokeless tobacco in the last 6 months, must be free of respiratory illness for a month before joining, and can't have health conditions affecting immune responses.Check my eligibility

What is being tested?

The study compares respiratory symptoms in people switching from banned flavored e-cigarettes to a non-banned flavor (tobacco) or 'tobacco free' nicotine pouches. It's randomized, meaning participants are put into groups by chance, and open-label so everyone knows which intervention they receive.See study design

What are the potential side effects?

Possible side effects may include irritation of the mouth or throat, coughing, headache, nausea, and potential worsening of pre-existing respiratory symptoms due to changes in vaping products.

CRoFT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been using electronic nicotine delivery systems daily for the past 6 months.

CRoFT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 90 days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Respiratory tract inflammation activity

Risk biomarkers of inflammation and oxidative stress as measured by ELISA

Secondary outcome measures

Amount of recent flavored product use

Flavor Preference questionnaire

Frequency of flavored product use

CRoFT Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Use Provided Tobacco FlavorExperimental Treatment1 Intervention

Participants will use a new assigned flavor for 90 days

Group II: Use Own Brand of Flavored ProductExperimental Treatment1 Intervention

Participants will use their current flavor of e cigarettes for 90 days

Group III: Vaping Abstinence - use "Tobacco Free" Nicotine PouchesActive Control1 Intervention

Participants will be asked to stop vaping for 90 days and instead only use the provided 'tobacco free' nicotine pouches.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of RochesterOTHER

837 Previous Clinical Trials

517,977 Total Patients Enrolled

2 Trials studying Vaping

4,202 Patients Enrolled for Vaping

National Cancer Institute (NCI)NIH

13,658 Previous Clinical Trials

40,924,425 Total Patients Enrolled

5 Trials studying Vaping

3,373 Patients Enrolled for Vaping

Roswell Park Cancer InstituteLead Sponsor

402 Previous Clinical Trials

30,642 Total Patients Enrolled

Media Library

E-cigarette Flavor (Flavor) Clinical Trial Eligibility Overview. Trial Name: NCT05423340 — N/A

Vaping Clinical Trial 2023: E-cigarette Flavor Highlights & Side Effects. Trial Name: NCT05423340 — N/A

E-cigarette Flavor (Flavor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05423340 — N/A

Frequently Asked Questions

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

Does this research project involve any senior citizens?

"The age range for people eligible to enroll in this trial are those between 21-55 years old."

Answered by AI

How many people are scientists testing this medication on?

"The listings on clinicaltrials.gov show that this research is still recruiting patients. This experiment was first advertised on June 23rd, 2022 and has been updated as recently as July 5th, 2022. The study needs 216 individuals at a single research site."

Answered by AI

Which type of patient would be a good candidate for this research?

"Eligible participants for this clinical trial must use electronic cigarettes and be aged 21-55. Up to 216 individuals will be accepted."

Answered by AI

Are researchers presently looking for participants for this trial?

"That is correct, the clinicaltrials.gov website has the most recent information on this study. The trial was first advertised on June 23rd, 2022 and was last updated July 5th, 2022. A total of 216 people will be participating at 1 location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of E-Liquid Flavor on Respiratory Symptoms in People Using Electronic Nicotine Delivery Systems

2022. "Effect of E-Liquid Flavor on Respiratory Symptoms in People Using Electronic Nicotine Delivery Systems". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05423340.