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

Description

This is a crossover study that will examine use behaviors, chemical exposures, and biological effects of Standardized Research Electronic Cigarette (SREC) compared to usual brand e-cigarette use in natural or synthetic nicotine users.

Conditions

Nicotine Dependence, Tobacco Toxicity, Cardiovascular Risk Factors

Study Overview

Study Details

Study overview

This is a crossover study that will examine use behaviors, chemical exposures, and biological effects of Standardized Research Electronic Cigarette (SREC) compared to usual brand e-cigarette use in natural or synthetic nicotine users.

Comparative Pharmacokinetics and Pharmacodynamics of Nicotine With Use of NIDA Standardized Research Electronic Cigarette (SREC) vs Usual Brand E-cigarette

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

Condition
Nicotine Dependence
Intervention / Treatment

-

Contacts and Locations

San Francisco

University of California, San Francisco - Tobacco Research Center, San Francisco, California, United States, 94143

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

21 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of California, San Francisco,

Neal Benowitz, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

2025-01-31