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Nicotine Reduction for Vaping Addiction
N/A
Recruiting
Led By Wasim Maziak, PhD, MD
Research Sponsored by Florida International University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age of 21-35 years
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the 2 participant visits. blood will be taken 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period
Awards & highlights
Study Summary
This trial will study the effects of nicotine reduction (NR) on young electronic nicotine delivery systems (ENDS) users as a potential regulatory strategy to reduce the addictiveness and use of ENDS.
Who is the study for?
This trial is for healthy adults aged 21-35 who use electronic cigarettes, can attend lab sessions, and have not used e-cigarettes for 12 hours before each visit. Pregnant or breastfeeding women, THC users, those with COVID-19 symptoms or exposure, regular tobacco/nicotine product users in the past year, people with chronic diseases or psychiatric conditions are excluded.Check my eligibility
What is being tested?
The study tests how reducing nicotine levels in electronic cigarettes affects addiction and usage among young adults. Participants will try e-cigarettes with different nicotine concentrations: 0%, 3%, and 5% to see if lower nicotine reduces addictiveness as part of a regulatory strategy.See study design
What are the potential side effects?
While specific side effects aren't listed for this trial, generally vaping can cause throat irritation, coughing, dry mouth and increased thirst; however these vary based on individual reactions to different levels of nicotine.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 21 and 35 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during the 2 participant visits. blood will be taken 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the 2 participant visits. blood will be taken 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Plasma nicotine
Secondary outcome measures
Carbon monoxide levels
Duke Sensory Questionnaire
Harm perception
+6 moreOther outcome measures
Blood pressure
Heart rate
Trial Design
3Treatment groups
Experimental Treatment
Group I: Electronic cigarette pods (SREC) with 0% nicotine concentrationExperimental Treatment1 Intervention
Participants will complete a lab visit where they will use 0% nicotine electronic cigarette pods ad libitum for up to 60 minutes.
Group II: Electronic cigarette pods (SREC or NJOY) with 5% nicotine concentrationExperimental Treatment1 Intervention
Participants will complete a lab visit where they will use 5% nicotine electronic cigarette pods ad libitum for up to 60 minutes.
Group III: Electronic cigarette pods (NJOY) with 3% nicotine concentrationExperimental Treatment1 Intervention
Participants will complete a lab visit where they will use 3% nicotine electronic cigarette pods ad libitum for up to 60 minutes.
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Who is running the clinical trial?
Florida International UniversityLead Sponsor
100 Previous Clinical Trials
17,435 Total Patients Enrolled
Wasim Maziak, PhD, MDPrincipal InvestigatorFlorida International University
1 Previous Clinical Trials
250 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot participate if you use homemade or non-commercial e-cigarette liquid or products.You have a long-term illness or mental health condition.I have a history of heart disease, blood pressure issues, seizures, or I regularly take prescription medication.I have been exposed to COVID-19 recently.You have used any tobacco or nicotine products regularly within the past year, such as hookah, pipes, or cigars.I am between 21 and 35 years old.You have used electronic cigarettes in the past month, either every day or occasionally.I am not pregnant or breastfeeding.I am currently experiencing symptoms like cough, fever, or chest pain.I have smoked more than 5 cigarettes a month in the past year.I haven't used electronic cigarettes for 12 hours before each session.
Research Study Groups:
This trial has the following groups:- Group 1: Electronic cigarette pods (SREC) with 0% nicotine concentration
- Group 2: Electronic cigarette pods (SREC or NJOY) with 5% nicotine concentration
- Group 3: Electronic cigarette pods (NJOY) with 3% nicotine concentration
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 remaining slots for participants in this research study?
"Per clinicaltrials.gov, this research is actively recruiting patients and has been since April 1st 2022 with its most recent update being on August 19th 2022."
Answered by AI
Can individuals consume 5% nicotine without undue health risks?
"There is extensive clinical data confirming the safety of 5% nicotine, warranting a score of 3. This phase 4 trial confirms that it has already been approved for use by medical professionals."
Answered by AI
How many participants are currently recruited for this experiment?
"Affirmative. The information available on clinicaltrials.gov indicates that this investigation is currently recruiting patients, starting from April 1st 2022 and most recently updated on August 19th 2022. A total of 120 individuals will be admitted to the single enrolment site for the trial."
Answered by AI
Is the eligibility criterion for this medical study restricted to individuals 50 years of age and above?
"According to the requirements for this trial, eligible participants must fall between 21 and 35 years of age."
Answered by AI
Am I qualified to partake in this clinical investigation?
"This experiment is looking for 120 participants aged between 21 and 35 with behavioural or substance addictions. To qualify, these criteria must be met."
Answered by AI
Who else is applying?
What site did they apply to?
Florida International University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
Trying to stop vaping.
PatientReceived 2+ prior treatments
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