Nicotine Vaping Variability for Vaping Study

Overseen By Stylianos C Mysirlidis, B.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: Anticoagulants, Blood thinners

Disqualifiers: Cardiovascular, Pulmonary, Pregnancy, Allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

15 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators will examine the relationship between nicotine flux, nicotine form, and the rate and dose of nicotine delivery. Participants will puff on electronic nicotine delivery system (ENDS) devices under conditions that differ by flux and form, while arterial blood is sampled in high time resolution. The outcome will indicate the degree to which nicotine flux and form determine the speed and dose of ENDS nicotine delivery, and thus, abuse liability.

Research Team

Stephen R Baldassarri, M.D.

Principal Investigator

Yale University

Eligibility Criteria

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.

Inclusion Criteria

Be willing to provide informed consent, attend the lab, and abstain from tobacco/nicotine as required

Have a normal Allen test

I am over 21 years old.

Exclusion Criteria

I have a condition affecting the blood vessels outside my heart and brain.

History of environmental - bronchospastic allergies, multiple chemical sensitivities, or other airway sensitivities that require the use of an epi pen or that in the investigator's view would make it risky for participation

I do not have ongoing lung or heart issues like chest pain or severe infections.

Treatment Details

Interventions

• Nicotine Flux

Trial Overview 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.

Participant Groups

Group I: Nicotine vaping group visit 2 Experimental Treatment 2 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 1 Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

American University of Beirut Medical Center

Collaborator

Trials

153

Recruited

113,000+