Nicotine Flux, a Potentially Powerful Tool for Regulating Nicotine Delivery From Electronic Cigarettes

Completed · Not applicable

Conditions studied: Nicotine Vaping

In brief

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.

Key facts

Study ID

NCT05706701

Run by

Yale University

People needed

36

Starts

2023-02-01

Expected to finish

2024-05-17

Last updated by the study team

2025-11-18

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Above 21 years of age
• Use ENDS at least 3 months and at least 3 times a week.
• Be willing to provide informed consent, attend the lab, and abstain from tobacco/nicotine as required.
• Have a normal Allen test

You may not qualify if…

• Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, or hepatic pathology that would increase risk or would interfere with/mimic tobacco abstinence
• Untreated, unresolved active pulmonary or cardiovascular conditions (i.e. chest pain, dyspnea, acute infection, recurring bronchitis, and reactive airway disorder)
• Breast-feeding or Pregnant (by urinalysis at screening).
• Vaping less than 3 months and less than 3 times per week
• Taking anticoagulants and blood thinners
• Known hypersensitivity to propylene glycol
• 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.
• Has current symptoms as identified by the Health Assessment Checklist including cough, shortness of breath, chest pain, nausea, vomiting, stomach pain, diarrhea, fever, chills, or weight loss
• Participants intending to quit tobacco/nicotine use in the next 30 days will be excluded and referred to cessation treatment.
• Abnormal Allen Test (impaired collateral circulation)
• Positive pregnancy test at any study visit
• Infection of skin or soft tissue at insertion site (erythema, swelling, ulceration)
• Peripheral vascular disease
• Coronary artery disease/advance atherosclerosis
• Raynaud's phenomenon
• Coagulopathy (hereditary bleeding disorders, advanced liver disease)
• Thromboangiitis obliterans
• COPD/emphysema/chronic bronchitis
• Allergy to lidocaine or anesthetics
• Inability to tolerate blood draws for any reason
• Additional Screening Procedures: Significant changes and/or abnormalities in these assessments during the study period may warrant exclusion at the discretion of the PI.
• Participants will be asked to answer the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) physical function scale and will be excluded if they report greater than "without any difficulty" on any single item as a screening tool
• Spirometry (baseline and before each visit)
• Physical Exam
• Application of the self-reported signs and symptoms health questionnaire with exclusion of those with chronic symptoms that would interfere with monitoring of vaping complications (baseline and * before each visit). Participants will be excluded and referred for medical treatment if they indicate dyspnea or cough symptoms are "severe."

Where it is running

• Human Research Unit (HRU) — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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