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Nicotine Vaping Variability for Vaping Study
N/A
Recruiting
Led By Stephen R Baldassarri, M.D.
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 and week 3
Awards & highlights
Study Summary
This trial will examine how the speed and dose of nicotine delivery from electronic devices varies by nicotine flux and form.
Who is the study for?
This trial is for adults over 21 who regularly use electronic nicotine delivery systems (ENDS) at least three times a week for the past three months. They must be willing to consent and attend lab sessions, abstain from tobacco/nicotine when required, and have normal blood flow in their hands as shown by an Allen test.Check my eligibility
What is being tested?
The study investigates how different forms of nicotine in vaping devices affect the speed and amount of nicotine entering the bloodstream. Participants will try vaping devices with varying levels of nicotine flux and form while having their arterial blood sampled frequently to measure these effects.See study design
What are the potential side effects?
Specific side effects are not listed, but participants may experience typical reactions associated with vaping such as throat irritation or coughing. The high-resolution blood sampling could potentially cause discomfort or bruising at the puncture site.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 and week 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 and week 3
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Maximum Arterial Blood Nicotine Delivery (Cmax)
Secondary outcome measures
Change in Area Under the Curve for Nicotine (AUC)
Change in Liquid Consumed
Change in Puff Topography
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Nicotine vaping group visit 2Experimental Treatment2 Interventions
The same subjects from visit 1 will receive the either free-base or protonated form of four nicotine fluxes: 9, 18, 27, 35 μg/sec at their second study visit, using the opposite nicotine form that was used during the first visit.
Group II: Nicotine vaping group visit 1Experimental Treatment2 Interventions
Subjects will receive the either free-base or protonated form of four nicotine fluxes: 9, 18, 27, 35 μg/sec at their first of two visits. In the first visit, participants will use the ENDS device with one nicotine form and four fluxes in random order. Participants will be instructed to attend the lab for a second visit, to test the four fluxes but with the other nicotine form.
Find a Location
Who is running the clinical trial?
American University of Beirut Medical CenterOTHER
142 Previous Clinical Trials
109,285 Total Patients Enrolled
Yale UniversityLead Sponsor
1,851 Previous Clinical Trials
2,738,198 Total Patients Enrolled
2 Trials studying Vaping
295 Patients Enrolled for Vaping
Stephen R Baldassarri, M.D.Principal InvestigatorYale University
1 Previous Clinical Trials
60 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition affecting the blood vessels outside my heart and brain.I do not have ongoing lung or heart issues like chest pain or severe infections.I don't have any major health issues that could affect or seem like quitting smoking.I have been diagnosed with Buerger's disease.I have COPD, emphysema, or chronic bronchitis.I have advanced heart artery disease.I have been vaping for less than 3 months and do it less than 3 times a week.I am currently taking medication to prevent blood clots.I am over 21 years old.I have been using electronic nicotine delivery systems for at least 3 months, 3 times a week.I have a bleeding disorder or severe liver disease.I am experiencing symptoms like cough, chest pain, or weight loss.I experience numbness and color changes in my fingers or toes in cold temperatures or stress.I have an infection where a medical device was inserted.
Research Study Groups:
This trial has the following groups:- Group 1: Nicotine vaping group visit 2
- Group 2: Nicotine vaping group visit 1
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.
Is enrollment for this experimental protocol still open?
"As revealed on clinicaltrials.gov, the post-date of this research (2/1/2023) and its most recent update (1/20/2023) both suggest that it is not currently recruiting participants. Nevertheless, there are 3 other trials actively seeking out eligible patients at present."
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