Pharmacokinetics and Pharmacodynamics of Nicotine With Use of Standardized Research Electronic Cigarette (SREC)

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Dec 16, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how different types of electronic cigarettes (e-cigarettes) affect the body, specifically looking at a special research device called the Standardized Research Electronic Cigarette (SREC). The goal is to compare how people use this device and how it influences their health compared to regular e-cigarettes. The study is open to healthy adults aged 21 to 70 who regularly use e-cigarettes and meet certain health criteria, such as having a normal heart rate and blood pressure.

Participants will need to be willing to stop using any other drugs during the study and must not have serious medical conditions like heart disease or diabetes. If you join the trial, you'll be asked to use the SREC and share information about your experiences with both devices. It's a great opportunity to contribute to research that could help understand the effects of e-cigarettes on health. Plus, you'll receive support and guidance throughout the process.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy on the basis of medical history and limited physical examination-
• • Heart rate \< 105 beats per minute (BPM)\*.
• • Systolic Blood Pressure \< 160 and \> 90\*.
• • Diastolic Blood Pressure \< 100 and \> 50\*.
• • \*considered out of range if both machine and manual readings are above/below these thresholds.
• • Body Mass Index \<= 38.0.
• • Current regular user of electronic cigarettes (EC)
• • EC device use at least 15 or more days in the past 30 days (with e- liquid \>= 3mg/ml)
• • No restriction on flavor or type of e-cigarette used
• • Saliva cotinine \>= 50 ng/ml and/or NicAlert = 6
• • Age \>= 21 years old \<= 70 years old
• • Willingness to abstain from drug use for the duration of the study
• Exclusion Criteria:
• * The following unstable medical conditions:
• • Heart disease
• • Seizures
• • Cancer
• • Thyroid disease (okay if controlled with medication)
• • Diabetes
• • Hepatitis B or C or Liver disease
• • Glaucoma
• • Kidney disease or urinary retention
• • History of stroke
• • An ulcer in the past year
• • Active use of an inhaler for Asthma or chronic obstructive pulmonary disease (COPD)
• • Medications
• • Use of medications that are inducers of nicotine metabolizing enzyme CYP2A6 (Example: rifampicin, carbamazepine, phenobarbital, and other anticonvulsant drugs).
• • Use of sympatholytic medications for cardiovascular conditions including hypertension (Example: beta and alpha-blockers).
• • Concurrent use of nicotine-containing medications (Example: nicotine patch, lozenge, gum).
• • Any stimulant medications (example: Adderall) generally given for attention deficit hyperactivity disorder (ADHD) treatment.
• • Other/Misc. Health Conditions
• • Oral thrush
• • Fainting (within the last 30 days)
• • Other "life threatening illnesses" as per principal investigator and/or study physician's discretion
• • Pregnancy
• • Pregnancy (self-reported and urine pregnancy test)
• • Breastfeeding (determined by self-report)
• • Women of childbearing potential must be using an acceptable method of contraception
• • Concurrent participation in another clinical trial.
• • Inability to read and write in English
• • Planning to quit smoking or vaping within the next 60 days
• • A known propylene glycol/vegetable glycerin allergy
• • Uncomfortable with getting blood drawn
• • Recent onset or change (worsening) in cough, fever and/or abdominal symptoms (vomiting or pain) in the past two weeks

Trial Officials