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Flavored ECIGs for Tobacco Addiction
N/A
Recruiting
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Smoke filtered cigarettes/machine-rolled cigarettes (≥5 cigarettes per day) or daily e-cigarette use for past year
No serious quit attempt in prior month. This includes use of any FDA approved smoking cessation medication (varenicline, bupropion [used specifically as a quitting aid], patch, gum, lozenge, inhaler, and nasal spray) in the past 1 month as an indication of treatment seeking
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-weeks post-randomization to 4-weeks post-randomization
Awards & highlights
Study Summary
This trial will test if people react to electronic cigarette flavors and nicotine levels the same way they react to drugs, which could help the FDA regulate flavors and smoking cessation.
Who is the study for?
This trial is for adults aged 21-60 who smoke cigarettes or use e-cigarettes daily and are willing to switch to study products for 4 weeks. Participants must be able to attend regular visits, undergo two fMRI scans, and have internet access. Pregnant women, individuals with severe claustrophobia, metal implants that affect MRI, seizure disorders, certain medical conditions or drug abuse are excluded.Check my eligibility
What is being tested?
The study tests the addictive potential of electronic cigarettes (ECIGs) by comparing nicotine-containing ECIGs with tobacco or strawberry vanilla flavor against placebo ECIGs without nicotine in both flavors. The goal is to see how flavor and nicotine influence addiction cues in the brain.See study design
What are the potential side effects?
Potential side effects from using ECIGs may include irritation of the mouth and throat, coughing, dry mouth, headache, dizziness, nausea or allergic reactions if sensitive to propylene glycol or vegetable glycerin.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have smoked more than 5 cigarettes a day or used e-cigarettes daily for the past year.
Select...
I haven't tried to quit smoking seriously in the last month.
Select...
I am between 21 and 60 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Baseline neural flavor cue-reactivity
Changes in neural flavor cue-reactivity
Secondary outcome measures
ECIG craving
ECIG dependence
ECIG liking and satisfaction
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: 18mg/ml Tobacco Flavor ECIGExperimental Treatment1 Intervention
Participants will be provided with an ECIG containing 15mg/ml nicotine concentration and a tobacco flavor.
Group II: 18mg/ml Strawberry Vanilla Flavor ECIGExperimental Treatment1 Intervention
Participants will be provided with an ECIG containing 15mg/ml nicotine concentration and a strawberry vanilla flavor.
Group III: 0mg/ml Tobacco Flavor ECIGPlacebo Group1 Intervention
Participants will be provided with an ECIG containing 0mg/ml nicotine concentration and a tobacco flavor.
Group IV: 0mg/ml Strawberry Vanilla Flavor ECIGPlacebo Group1 Intervention
Participants will be provided with an ECIG containing 0mg/ml nicotine concentration and a strawberry vanilla flavor.
Find a Location
Who is running the clinical trial?
Milton S. Hershey Medical CenterLead Sponsor
494 Previous Clinical Trials
2,798,786 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,697 Previous Clinical Trials
6,952,758 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I understand and agree to the study's procedures.I am currently diagnosed with depression or anxiety.I do not have severe immune, respiratory, kidney, or liver diseases that could affect my safety in the trial.You have been using illegal drugs or taking prescription drugs without a medical reason on a regular basis (almost every day or every week) in the past 3 months, as determined by a screening test from the National Institute on Drug Abuse. This does not include marijuana use.I have smoked more than 5 cigarettes a day or used e-cigarettes daily for the past year.I can attend all appointments for the next 4 weeks without any planned interruptions.I have a condition that affects my thinking or nervous system.I haven't tried to quit smoking seriously in the last month.I am between 21 and 60 years old.You are willing to have two brain scans using a machine called fMRI.I am willing to switch to e-cigarettes or use a study product instead of smoking for 4 weeks.I haven't had a heart attack, stroke, or severe angina in the last year.I have had a seizure or been diagnosed with a seizure disorder in the last year.I am on medication to prevent seizures.I am not pregnant, trying to conceive, or breastfeeding.You have a strong fear of small, enclosed spaces.You have an allergy to propylene glycol or vegetable glycerin.
Research Study Groups:
This trial has the following groups:- Group 1: 18mg/ml Tobacco Flavor ECIG
- Group 2: 0mg/ml Tobacco Flavor ECIG
- Group 3: 18mg/ml Strawberry Vanilla Flavor ECIG
- Group 4: 0mg/ml Strawberry Vanilla Flavor ECIG
Awards:
This trial has 0 awards, including: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.
Who is the ideal cohort to include in this research experiment?
"This medical trial seeks 56 individuals aged 21-60 who suffer from tobacco dependence. Eligible applicants mustn't have attempted a serious quit attempt in the past month and are willing to supplement their cigarette smoking with e-cigarette use for 4 weeks or replace it with study product, attend regular visits over four consecutive weeks, undergo two fMRI scans, read/write English fluently, comprehend & consent to stated procedures, and possess access to computer connected to internet (enabling Zoom video conferencing)."
Answered by AI
Is this research project still open to recruiting new participants?
"As per records from clinicaltrials.gov, this medical trial is presently in the recruitment phase, having been posted on November 4th 2019 and updated as recently as December 1st 2022."
Answered by AI
How much capacity does this clinical trial have for participants?
"Affirmative. The clinical trial details listed on clinicaltrials.gov demonstrate that patient recruitment for this research project is ongoing, having been first launched in November of 2019 and last updated in December 2022. 56 individuals are being sought from a single enrolment centre."
Answered by AI
Is this research endeavor accepting elderly individuals as participants?
"The guidelines for this clinical trial stipulate that suitable candidates should range in age from 21 to 60. Furthermore, there are 4 trials meant exclusively for patients below the legal age of consent and 76 trails devoted solely to those over 65 years old."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Penn State Health
Why did patients apply to this trial?
Because I smoke e cigarettes.
PatientReceived no prior treatments
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