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

NCT04053868 | Completed Results DMC

• 2 other identifiers: 19-283092R01DA039264-04A1
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Nicotine Administration & Dosage; E-cigarettes; Vaping; E-Liquid; Tobacco Smoking

Outcome Measures

Primary Outcomes (1)

• Mean Nicotine Exposure

  Plasma nicotine area under the concentrated time curve (AUC) (ng/ml\*h)

  Plasma collected at baseline (prior to any product use) and at 2, 5, 7, 10, 15, 30, 60, 90, and 118 minutes after end of standardized session.

Secondary Outcomes (6)

• Overall Mean Heart Rate Over Time

  Up to 118 minutes after end of standardized session.

• Mean Systolic Blood Pressure Over Time

  Up to 118 minutes after end of standardized session.

• Mean Diastolic Blood Pressure Over Time

  Up to 118 minutes after end of standardized session.

• Mean Questionnaire of Smoking Urges (QSU) and Modified for E-cigarettes (mQSU) Score Over Time

  Up to 118 minutes after end of standardized session

• Mean Minnesota Nicotine Withdrawal Scale (MNWS) Score Over Time

  Up to 118 minutes after end of standardized session.

Study Arms (2)

Electronic Cigarette

EXPERIMENTAL

The participants will participate in a standardized vaping session using a JUUL E-cigarette device with a JUUL e-liquid pod.

Other: JUUL

Tobacco Cigarette

EXPERIMENTAL

The participants will participate in a standardized smoking session using commercial tobacco cigarettes.

Other: Tobacco

Interventions

JUUL OTHER

Electronic Cigarette

Electronic Cigarette

Tobacco OTHER

Tobacco Cigarette

Tobacco Cigarette

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy on the basis of medical history and limited physical examination, as described below:
• \- Heart rate \< 105 beats per minute (bpm)
• \- - Considered out of range if both machine and manual readings are above/below these thresholds.
• \- Systolic Blood Pressure \< 160 and \> 90\*
• \- Diastolic Blood Pressure \< 100 and \> 50\*
• Age: \>= 21 \& \<=70 years old
• Body Mass Index (BMI) \<= 38.0 (at PI's discretion for higher BMI if no other concurrent health issues)
• Willingness to avoid combusted marijuana up to 48 hours before each study visit
• Nicotine strength of e-liquid of usual e-cigarette \> 0 mg/ml
• Group 1 Experienced E-cigarette users
• \- Current use of tobacco cigarettes (\<5 cigarettes per day)
• \- Current e-cigarette use at least 15 days out of the past 30 days of a non-mod e-cigarette
• Group 2 Primary Tobacco cigarette users:
• \- Currently smoking \>= 5 cigarettes per day
• \- Current e-cigarette use must be \< 5 times per month

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Vaping; Tobacco Smoking

Interventions

Tobacco Products

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Dr. Neal Benowitz
• Organization: University of California San Francisco

neal.benowitz@ucsf.edu

628-206-8324

Study Officials

• Neal L Benowitz, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2019
• First Posted: August 13, 2019
• Study Start: December 9, 2019
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: October 16, 2025
• Results First Posted: August 15, 2023

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)