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Heated Tobacco Product
Heated Tobacco Product as a Substitute for Menthol Cigarettes in Tobacco Use
N/A
Recruiting
Led By Andrew J Barnes, 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
Healthy adults (aged 21 and older)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 2 (intervention week), tuesday-thursday
Awards & highlights
Study Summary
This trial will help determine if policies restricting access to menthol-flavored HTPs will have an impact on menthol cigarette smokers.
Who is the study for?
This trial is for healthy adults over 21 who smoke menthol cigarettes daily. They must have a positive nicotine test, abstain from nicotine for at least 8 hours before lab sessions, and be able to interact with daily surveys via computer or smartphone. Pregnant or breastfeeding women, those with chronic conditions, or users of non-cigarette tobacco products cannot participate.Check my eligibility
What is being tested?
The study is testing the potential of IQOS, a Heated Tobacco Product (HTP), as an alternative to menthol cigarettes. It assesses how appealing this product is compared to traditional menthol cigarettes through both lab tests and real-world use by participants.See study design
What are the potential side effects?
While specific side effects are not listed here due to the nature of the product being tested (a tobacco product), typical risks associated with tobacco use may include respiratory issues, increased heart rate, addiction potential, and other health risks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 21 years old or older and in good health.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 2 (intervention week), tuesday-thursday
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 2 (intervention week), tuesday-thursday
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
Plasma Nicotine Delivery
Willingness to Substitute from Cigarettes to HTPs
Secondary outcome measures
Average daily IQOS Usage
Cigarette Craving Suppression
Percentage of total tobacco consumption that is IQOS
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Menthol-Flavored IQOSExperimental Treatment1 Intervention
Menthol - where menthol smokers will only have access to menthol-flavored HeatSticks to use in the IQOS 2.4 Tobacco Heating System
Group II: Tobacco-Flavored IQOSActive Control1 Intervention
Tobacco - where menthol smokers will only have access to tobacco-flavored HeatSticks to use in the IQOS 2.4 Tobacco Heating System
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tobacco product administration and assessment
2016
N/A
~60
Find a Location
Who is running the clinical trial?
Virginia Commonwealth UniversityLead Sponsor
698 Previous Clinical Trials
22,884,945 Total Patients Enrolled
1 Trials studying Tobacco Use
41 Patients Enrolled for Tobacco Use
National Institute on Drug Abuse (NIDA)NIH
2,468 Previous Clinical Trials
2,619,298 Total Patients Enrolled
30 Trials studying Tobacco Use
6,183 Patients Enrolled for Tobacco Use
Andrew J Barnes, PhDPrincipal InvestigatorVirginia Commonwealth University
2 Previous Clinical Trials
235 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- We cannot share all the details about who can participate in the study yet, because we want to make sure the results are accurate. We will share the full criteria after the study is finished.I agree to not use nicotine or tobacco for 8 hours before lab visits.I am 21 years old or older and in good health.I am not pregnant or breastfeeding.You smoke menthol cigarettes every day.You use tobacco products every day, except for cigarettes.You have a long-term medical or mental health condition that you have told us about.
Research Study Groups:
This trial has the following groups:- Group 1: Menthol-Flavored IQOS
- Group 2: Tobacco-Flavored IQOS
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 we looking for more patients to enroll in this trial?
"From what is published on clinicaltrials.gov, it appears that this study is not currently looking for participants. This particular trial was posted on December 1st, 2022 and last updated on October 31st, 2022. There are, however, 55 other trials that are still recruiting patients."
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