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Vaping for Smokers' Cancer Risk
N/A
Waitlist Available
Led By Ahmad Besaratinia
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Being male or female between the ages of 22-55
Reporting smoking of > 5 manufactured cigarettes per day for at least 1 year (applicable to participants who will undergo intervention with e-cig (Grp 1) or continue to smoke (Grp 2) only)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 2 weeks for 3 months
Awards & highlights
Study Summary
This trial will study the health risks or benefits of e-cig use relative to cigarette smoking in 150 people. The investigators will use an integrative 'multi-omics' approach, looking at changes in the genome, epigenome, and transcriptome relevant to cancer in the oral cells of the participants.
Who is the study for?
This trial is for smokers aged 22-55 who've smoked more than 5 cigarettes daily for over a year and want to switch to vaping, continue smoking, or remain smoke/vape-free. Participants must be able to consent and follow the study without major life disruptions. Those with severe mental illness, substance abuse, extreme body weight, recent pregnancy or drug use, certain medical conditions or treatments are excluded.Check my eligibility
What is being tested?
The study compares cancer-related biomarkers in oral cells among three groups: smokers switching to e-cigarettes (Grp 1), regular smokers (Grp 2), and non-smokers/non-vapers (Grp 3). It uses 'multi-omics' analysis on genome changes relevant to cancer risk during the intervention.See study design
What are the potential side effects?
Potential side effects may include irritation from e-cigarette ingredients like propylene glycol/vegetable glycerin in those switching from smoking to vaping. Regular health risks associated with continued smoking will persist for Grp 2.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 22 and 55 years old.
Select...
I have smoked more than 5 cigarettes daily for at least a year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 2 weeks for 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 2 weeks for 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Epigenetic changes
Genetic changes
Secondary outcome measures
DNA methylation
Gene expression
Histone modifications
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: VapersExperimental Treatment1 Intervention
Smokers will switch to NIDA Standard Research E-cigarette (SREC).
Group II: SmokersActive Control1 Intervention
Smokers will continue to smoke.
Group III: Nonsmokers non-vapersActive Control1 Intervention
Control nonsmokers non-vapers will continue to refrain from smoking or vaping.
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Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
905 Previous Clinical Trials
1,596,128 Total Patients Enrolled
University of CaliforniaOTHER
42 Previous Clinical Trials
417,198 Total Patients Enrolled
Ahmad BesaratiniaPrincipal InvestigatorUniversity of Southern California
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 22 and 55 years old.You have a body mass index (BMI) that is either too low or too high.I do not plan to move, take long vacations, or have surgery during the study.I have smoked more than 5 cigarettes daily for at least a year.I have taken medication that affects the CYP450 2A6 enzyme.You have used drugs for fun or illegally in the last 3 months.I haven't had any serious or unstable health issues like heart problems in the last year.You have a mental illness or struggle with substance abuse, and it is not currently under control.I have oral health issues or conditions like diabetes, asthma, or kidney disease.
Research Study Groups:
This trial has the following groups:- Group 1: Vapers
- Group 2: Smokers
- Group 3: Nonsmokers non-vapers
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.
What specific outcomes is this clinical trial seeking to evaluate?
"This trial, which is set to span a period of 3 months, aims to observe genetic modifications as its primary outcome. Secondary outcomes include relative gene expression augmentation, alteration in mutation frequency and location along with aberrant DNA methylation patterns and distributions."
Answered by AI
Does the protocol for this research encompass seniors?
"This trial is looking for volunteers who are between 22 and 55 years old."
Answered by AI
Who would be an eligible candidate for this clinical trial?
"This trial is accepting approximately 150 individuals who have a history of smoking cigarettes and are aged between 22 to 55."
Answered by AI
Does this clinical trial have any available slots for participants?
"Clinicaltrials.gov indicates that this particular medical trial is no longer recruiting patients, with the original posting being made on June 1st 2022 and last update occurring December 1st 2021. Although this study has ended recruitment, 47 other studies are presently welcoming participants to join their trials."
Answered by AI
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