N/A
Completed N=17
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
| Outcome | Result | p-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
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.