Clinical trial NCT05658471: Pharmacokinetics and Pharmacodynamics of Nicotine With Use of Standardized Research Electronic Cigarette (SREC)
Official title: Comparative Pharmacokinetics and Pharmacodynamics of Nicotine With Use of NIDA Standardized Research Electronic Cigarette (SREC) vs Usual Brand E-cigarette
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nicotine Dependence
Tobacco Toxicity
Cardiovascular Risk Factors
Keywords: Nicotine Pharmacokinetics
Nicotine Pharmacodynamics
Electronic Cigarettes
E-Cigarettes
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-12-20
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be randomized to the starting condition using a Latin square design
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: OBJECTIVES:

I. To characterize nicotine delivery, systemic exposure and effects from SREC in comparison with usual to usual nicotine brand use.

II. To assess aspects of harm of SREC use compared to usual nicotine brand use.

OUTLINE:

Eligible participants will be assigned to one of two treatment conditions for the initial assessment which will take place in a hospital setting. The participant will then be assigned to the second condition within 2 weeks after the initial assessment which will also take place in a hospital setting to repeat the same procedures.

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

Primary outcomes:
measure: Mean Peak Nicotine Concentration
timeFrame: Collected 2, 5, 7, 10, 15, 30, 45, 60, 75, 90, and 120 minutes post end vaping session
measure: Mean Time of Peak Nicotine Concentration
timeFrame: Collected 2, 5, 7, 10, 15, 30, 45, 60, 75, 90, and 120 minutes post end vaping session
measure: Area Under the plasma nicotine concentration-time Curve (AUC) at 120 minutes
timeFrame: Collected 2, 5, 7, 10, 15, 30, 45, 60, 75, 90, and 120 minutes post end vaping session
measure: Mean overall systemic nicotine exposure
timeFrame: during the 3 hr of ad libitum use
measure: Mean inter-puff interval
timeFrame: during the 3 hr of ad libitum use
measure: Change in Mean score on the Modified Cigarette Evaluation Questionnaire (mCEQ)
timeFrame: Up to 1 month
measure: Change in Mean score on the Minnesota Tobacco Withdrawal Scale-Revised (MTWS-R)
timeFrame: Up to 1 month
measure: Change in Mean score on the Questionnaire on Smoking Urges (QSU-Brief)
timeFrame: Up to 1 month
Secondary outcomes:
measure: Mean acrolein levels within participants
timeFrame: Up to 1 month
measure: Mean propylene oxide levels within participants
timeFrame: Up to 1 month
measure: Median benzene levels within participants
timeFrame: Up to 1 month
measure: Mean heart rate within participants
timeFrame: Up to 1 month
measure: Mean blood pressure (both systolic and diastolic) within participants
timeFrame: Up to 1 month
measure: Mean plasma epinephrine within participants
timeFrame: Up to 1 month
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco - Tobacco Research Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Neal Benowitz, MD
role: PRINCIPAL_INVESTIGATOR
References: