Pharmacokinetics and Pharmacodynamics of Different Nicotine Salt Concentration Vape System Pods and Free-base Nicotine

NCT04170907 | Completed DMC

• 1 other identifier: Nicotine PK PD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison of the pharmacokinetics and pharmacodynamics of two different nicotine salt concentrations and free-base nicotine using an open vape pod system

Conditions

Nicotine Dependence

Keywords

nicotine; pharmacokinetics; pharmacodynamics

Outcome Measures

Primary Outcomes (1)

• Nicotine Peak Plasma Concentration (Cmax)

  Comparison of nicotine Cmax between groups

  Blood samples collection: 15 minutes before and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff

Secondary Outcomes (13)

• Area under the plasma concentration versus time curve (AUC)

  Blood samples collection: 15 minutes before and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff

• Time at which the Cmax is observed (Tmax)

  Blood samples collection: 15 minutes before and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff

• Elimination half-life (t1/2)

  Blood samples collection: 15 minutes before and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff

• Genotyping of the hepatic cytochrome P450 enzyme CYP2A6

  Blood sample collection during first session

• Nicotine metabolite ratio (NMR)

  Assessed at screening visit

Study Arms (3)

Nicotine salt 20 mg/mL

OTHER

Vaping of nicotine salt e-liquids with a nicotine concentration of 20 mg/mL.

Other: standardized vaping protocol

Nicotine salt 40 mg/mL

OTHER

Vaping of nicotine salt e-liquids with a nicotine concentration of 40 mg/mL.

Other: standardized vaping protocol

Free-base nicotine 20 mg/mL

OTHER

Vaping of free-base nicotine e-liquids with a nicotine concentration of 20 mg/mL.

Other: standardized vaping protocol

Interventions

standardized vaping protocol OTHER

The following questionnaires will first be completed: Modified Minnesota Nicotine Withdrawal Scale, Tiffany Questionnaire on Smoking Urges-Brief total (global) craving score, Positive and Negative Affect Schedule. The assigned product will then be given to the participant, and one puff will be taken every 30 seconds (total of 10 puffs). Blood samples will be collected 15 minutes before vaping and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff. Heart rate and blood pressure will be measured 15 minutes before and 2, 10, 15, 30, 60, 120, and 180 minutes after the last puff. Post-use withdrawal, craving, reward, and satisfaction will be assessed 10 minutes and 1 and 3 hours after the last puff. Respiratory Symptoms will be assessed at baseline and 5 minutes after the last puff. Ten minutes post-use, the direct effects will also be assessed.

Free-base nicotine 20 mg/mL; Nicotine salt 20 mg/mL; Nicotine salt 40 mg/mL

Eligibility Criteria

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

You may qualify if:

• Men or women, age 18 or older at screening, who have used electronic cigarettes and/or smoked at least 5 cigarettes per day in the past 30 days
• Saliva cotinine of \> 50 ng/mL at screening
• No clinically significant findings on the physical examination at screening
• Ability to communicate well with the investigator and to understand and comply with the requirements of the study
• Women of child-bearing age: willingness of using a reliable contraception method during the study
• Signed informed consent

You may not qualify if:

• Known hypersensitivity/allergy to a content of the e-liquid
• Pregnancy or breast feeding
• BMI \< 18 or \> 28 kg/m2 at screening
• History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening
• Loss of ≥ 250 ml of blood within 3 months prior to screening, including blood donation
• Treatment with an investigational drug within 30 days prior to screening
• Treatment with prescribed or over-the-counter (OTC) medications with potential influence on CYP2A6 function within 1 week prior to screening (with the exception of contraception)
• History or clinical evidence of any disease (e.g. gastrointestinal tract-disease) and/or existence of any surgical or medical condition, which in the opinion of the investigator might interfere with the absorption, distribution, metabolism or excretion of the study drugs, or which might increase the risk for toxicity
• Legal incapacity or limited legal capacity at screening
• Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Bern: collaborator

Study Sites (1)

Inselspital, University Hospital Bern

Bern, Canton of Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

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

Study Officials

• Evangelia Liakoni, MD

  Sponsor: Inselspital, Bern University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Vaping of high and low concentration nicotine salt and free-base nicotine will be double-blinded.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be switched in a within-subject crossover design among the three product types.

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 20, 2019
• Study Start: April 19, 2022
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: January 8, 2025

Record last verified: 2025-01

Locations

CH (1)