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E-Cigarette Flavor Impact for ENDS Flavors (RVA Flavors Trial)
N/A
Recruiting
Led By Caroline O Cobb, PhD
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
21+ years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1 vs. week 6
Awards & highlights
RVA Flavors Trial Summary
This trial will test how flavors in electronic cigarettes impact African American smokers who use menthol cigarettes, in terms of tobacco use, exposure to harmful chemicals, and addiction potential.
Who is the study for?
This trial is for African American menthol cigarette smokers over 21 who smoke more than 5 cigarettes a day and have used electronic cigarettes in the last month. Participants should not plan to quit smoking soon, must be able to complete surveys, and have a mobile phone with text/data plans. Those using marijuana or other drugs frequently, pregnant women, or those with serious health issues can't join.Check my eligibility
What is being tested?
The study examines how different flavors of electronic cigarettes like menthol affect tobacco use habits, exposure to harmful substances, and potential for abuse among participants.See study design
What are the potential side effects?
While specific side effects are not detailed here as it's an observational study on behavior and exposure rather than drug effects, general risks may include nicotine addiction and respiratory impacts from ENDS usage.
RVA Flavors Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 21 years old.
RVA Flavors Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 1 vs. week 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1 vs. week 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Average Daily Cigarette Use
Change in Carbon Monoxide Exposure
Willingness to Substitute from Cigarettes to ENDS
Secondary outcome measures
Change in Average Daily ENDS Use
Change in NNAL Exposure
Change in Proplyne Glycol Exposure
+1 moreRVA Flavors Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: UnflavoredExperimental Treatment1 Intervention
Unflavored - where only unflavored liquid is available for electronic nicotine delivery systems
Group II: TobaccoExperimental Treatment1 Intervention
Tobacco - where only tobacco flavored liquid is available for electronic nicotine delivery systems
Group III: Menthol+TobaccoActive Control1 Intervention
Menthol+Tobacco - where both menthol and tobacco flavored liquids for electronic nicotine delivery systems are available to choose from
Find a Location
Who is running the clinical trial?
Virginia Commonwealth UniversityLead Sponsor
699 Previous Clinical Trials
22,884,835 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,470 Previous Clinical Trials
2,619,520 Total Patients Enrolled
Caroline O Cobb, PhDPrincipal InvestigatorVirginia Commonwealth University
2 Previous Clinical Trials
68 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not willing to use electronic nicotine delivery systems in the trial.I have tried to quit smoking before using a method supported by research.You have used electronic nicotine delivery systems (ENDS) in the last 30 days.I have not had any serious or unstable health issues in the last year.You plan to continue smoking for the next 6 months.You smoke at least five cigarettes every day for one year or longer.I am over 21 years old.You self-identify as Black or African American, regardless of other racial identities.You smoke cigarettes that have a mint or menthol flavor.
Research Study Groups:
This trial has the following groups:- Group 1: Menthol+Tobacco
- Group 2: Tobacco
- Group 3: Unflavored
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 there any criteria determining eligibility for participation in this clinical trial?
"This trial is seeking 210 patients who are between 21 and 55 years old, and who use electronic nicotine delivery systems (ENDS) with flavours."
Answered by AI
How many participants are actively engaging in this research?
"Affirmative. As indicated on clinicaltrials.gov, this experiment is now recruiting participants and has been listed from April 14th 2022 to August 10th 2022. 210 volunteers are needed for the trial at a single site."
Answered by AI
Is enrollment to this trial still available for prospective participants?
"As of now, the trial is still actively searching for participants. The details were initially posted on April 14th 2022 and underwent a modification as recently as August 10th 2022 according to clinicaltrials.gov."
Answered by AI
Are participants aged 45 and older being sought for this investigation?
"The age range for eligibility in this trial lies between 21 and 55."
Answered by AI
What expectations do researchers have for the results of this experiment?
"Through this clinical trial, primary outcomes are being measured over a Week 1 to Week 6 period. The metric for evaluation is Change in Carbon Monoxide Exposure. Secondary metrics include Change in Proplyne Glycol Exposure (a biomarker of ENDS use), the average daily ENDS Use (number of puffs per day calculated from text surveys) and Willingness to Pay for ENDS (assessed through drug purchase tasks)."
Answered by AI
Who else is applying?
What site did they apply to?
Virginia Commonwealth University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
To help me stop smoking.
PatientReceived 1 prior treatment
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