Vaping High vs. Low Nicotine E-Liquid

NCT04047836 | Withdrawn DMC

• 2 other identifiers: 19-275715R01DA031193
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

This study will examine the effects of electronic cigarette e-liquid nicotine content in a randomized, crossover clinical and behavioral pharmacology study of experienced adult e-cigarette users (N=36). The specific aim is to determine the impact of nicotine content of e-liquid on nicotine pharmacology, systemic exposure to toxic volatile organic compounds, and short-term cardiovascular effects.

Conditions

Cardiovascular Risk Factor; Nicotine Dependence

Keywords

E-Cigarettes; Vaping; E-Cig Mods; E-Liquid

Outcome Measures

Primary Outcomes (4)

• Nicotine Exposure

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

  Day 1 of each Arm

• Cardiovascular Effects: Heart Rate

  Participant heart rate will be measured in beats per minute throughout the inpatient stay.

  Days 1-3 of each Arm

• Cardiovascular Effects: Systolic Blood Pressure

  Participant systolic blood pressure will be taken for 24 hours during ad-lib e-cigarette use.

  Day 2 of each Arm

• Cardiovascular Effects: Diastolic Blood Pressure

  Participant diastolic blood pressure will be taken for 24 hours during ad-lib e-cigarette use.

  Day 2 of each Arm

Secondary Outcomes (3)

• Vaping Topography: Puff Number

  Days 1-3 of each Arm

• Vaping Topography: Puff Duration

  Days 1-3 of each Arm

• Vaping Topography: Inter-Puff Interval

  Days 1-3 of each Arm

Study Arms (2)

Low Nicotine

OTHER

Using an electronic cigarette, the patient will participate in a standardized vaping session using 3 mg/ml nicotine e-liquid.

Other: Low Nicotine E-Liquid

Medium or High Nicotine

OTHER

The patient will participate in a standardized vaping session using either an electronic cigarette with 18 mg/ml nicotine e-liquid or a JUUL device with a JUUL e-liquid pod.

Other: Medium or High Nicotine E-Liquid

Interventions

Low Nicotine E-Liquid OTHER

Participants will vape e-liquid with nicotine concentration of 3 mg/ml.

Low Nicotine

Medium or High Nicotine E-Liquid OTHER

Participants will vape either e-liquid with nicotine concentration of 18 mg/ml or a JUUL device with JUUL pod of 59 mg/ml nicotine e-liquid.

Medium or High Nicotine

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)\*
• 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.
• Age: \>= 21 years
• Age: \<= 70 years
• Current regular user of open tank electronic cigarette (EC) (at least 20 times in the past 30 days) with e-liquid nicotine of 3-6 mg/mL.
• Non-smoker or non-daily cigarette smokers agreeing to abstain from cigarettes for the duration of the study.
• Saliva cotinine \>50 ng/mL and/or NicAlert=6
• Carbon monoxide \>= 5 ppm or per discretion of Principal Investigator

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)

University of California, San Francisco

San Francisco, California, 94110, United States

Location

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Vaping

Interventions

Culture Media

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Smoking; Behavior

Intervention Hierarchy (Ancestors)

Laboratory Chemicals; Specialty Uses of Chemicals; Chemical Actions and Uses; Equipment and Supplies

Study Officials

• Neal Benowitz, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Crossover Assignment

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: August 7, 2019
• Study Start: June 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)