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Not Yet Recruiting NCT05706701

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

Conditions: Nicotine Vaping

Sex: All
Ages: 21 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 15
Sponsor: Yale University

Location: United States

Summary

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.

Eligibility Criteria

Inclusion Criteria:Above 21 years of ageUse 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 testExclusion Criteria:Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, or hepatic pathology that would increase risk or would interfere with/mimic tobacco abstinenceUntreated, 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 weekTaking anticoagulants and blood thinnersKnown hypersensitivity to propylene glycolHistory 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.Not fully vaccinated for COVID 19.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 lossParticipants 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 visitInfection of skin or soft tissue at insertion site (erythema, swelling, ulceration)Peripheral vascular diseaseCoronary artery disease/advance atherosclerosisRaynaud's phenomenonCoagulopathy (hereditary bleeding disorders, advanced liver disease)Thromboangiitis obliteransCOPD/emphysema/chronic bronchitisAllergy to lidocaine or anestheticsInability to tolerate blood draws for any reasonAdditional 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 toolSpirometry (baseline and before each visit)Physical ExamApplication 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."PROMIS Dyspnea Severity Item PoolPROMIS Dyspnea CharacteristicsPROMIS Fatigue Short FormFunctional Assessment of Chronic Illness Therapy (FACIT) Cough item

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05706701). StuddyBuddy aggregates publicly available trial information.