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N/A Completed N=17 Randomized Basic Science

Evaluating the Comparative Pharmacokinetics of Nicotine After Administration Via JUUL or Tobacco Cigarettes

Nicotine Administration & Dosage · E-cigarettes · Vaping · E-Liquid
Source: ClinicalTrials.gov NCT04053868 ↗
Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcomePrimary: Mean Nicotine Exposure — 4.6; 9.2 ng/ml*h

Summary

This is an observational, crossover design that will examine the pharmacokinetics and pharmacodynamics of impact of smoking tobacco cigarettes or vaping the JUUL electronic cigarette.

Outcome Measures

OutcomeResultp-value
PRIMARY
Mean Nicotine Exposure
4.6; 9.2
SECONDARY
Overall Mean Heart Rate Over Time
69.4; 73.4
SECONDARY
Mean Systolic Blood Pressure Over Time
123; 122
SECONDARY
Mean Diastolic Blood Pressure Over Time
75.6; 76.9
SECONDARY
Mean Questionnaire of Smoking Urges (QSU) and Modified for E-cigarettes (mQSU) Score Over Time
20.9; 19.0; 13.5; 11.3
SECONDARY
Mean Minnesota Nicotine Withdrawal Scale (MNWS) Score Over Time
12; 11
SECONDARY
Mean Cigarette Evaluation Scale (CES) and Modified for E-cigarettes (mCES) Score Over Time
49.5; 47.7

Eligibility Criteria

Inclusion Criteria

  • Healthy on the basis of medical history and limited physical examination, as described below:
  • - Heart rate 90*
  • - Diastolic Blood Pressure 50*
  • Age: >= 21 & 0 mg/ml
  • Group 1 Experienced E-cigarette users
  • - Current use of tobacco cigarettes ( = 5 cigarettes per day
  • - Current e-cigarette use must be =50 ng/ml or urine cotinine and/or NicAlert=6
  • Must have a smart phone, computer, or tablet and internet access (for remote procedures)

Exclusion Criteria

  • Medical
  • - 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)
  • Psychiatric conditions
  • - Current or past schizophrenia, and/or current or past bipolar disorder
  • - Major depression, current or within the past year
  • - Major personality disorder
  • - Participants with current or past minor or moderate depression and/or anxiety disorders will be reviewed by the principal investigator (PI) and/or medical monitor and considered for inclusion
  • - History of psychiatric hospitalizations are not exclusionary, but study participation will be determined as per PI's or medical monitor's approval
  • Drug/Alcohol Dependence
  • - Alcohol or illicit drug dependence within the past 12 months with the exception of those who have recently completed an alcohol/drug treatment program
  • - Positive toxicology test for illicit drugs at the screening visit (Tetrahydrocannabinol (THC) & prescribed medications okay)
  • - Opioid replacement therapy (including methadone, buprenorphine, or other)
  • Psychiatric medications
  • - Current regular use of any psychiatric medications is exclusionary, with the exception of Selective Serotonin Reuptake Inhibitor (SSRI) and serotonin-norepinephrine reuptake Inhibitor (SNRI) and current evaluation by the PI and/or medical monitor that the participant is otherwise healthy, stable, and able to participate
  • Medications
  • - Use of sympatholytic medications for cardiovascular conditions including hypertension (Example: beta and alpha-blockers)
  • - Use of medications that are inducers of nicotine metabolizing enzyme CYP2A6 (Example: rifampicin, carbamazepine, phenobarbital, and other anticonvulsant drugs)
  • - Concurrent use of nicotine-containing medications
  • - Any stimulant medications (example: Adderall) generally given for attention deficit hyperactivity disorder (ADHD) treatment
  • Use of Other Tobacco Products (OTP)
  • - Any of the following products in combination more than 15 times in the past month
  • - - smokeless tobacco (snus, oral snuff, chewing tobacco)
  • - - pipes
  • - - cigars, cigarillos, little cigars
  • - - blunts, spliffs
  • - - hookah
  • Other/Misc. Chronic Health Conditions
  • Fainting (within the last 30 days)
  • Other "life threatening illnesses" as per PI's or medical monitor's discretion
  • Pregnancy
  • - Pregnancy (self-reported and urine pregnancy test)
  • - Breastfeeding (determined by self-report)
  • Concurrent participation in another clinical trial (at PI's discretion)
  • Inability to read and write in English
  • Planning to quit smoking or vaping within the next 60 days
  • Recent onset or change (worsening) in cough, fever and/or abdominal symptoms (vomiting or pain) in the past two weeks
  • Diagnosis of pneumonia in the past 3 months
  • Uncomfortable with blood draws
  • Known allergy to propylene glycol or vegetable glycerin
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04053868). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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