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Pharmacokinetics, Subjective Effects, and Abuse Liability of Nicotine Salt-Based Vaping Products With Tobacco or Unflavored E-liquids, SALTVAPE Study

NCT04231539 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-10-31

Study results available
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Summary

This trial studies activity of time (pharmacokinetics), subjective effects, and abuse liability of nicotine salt-based vaping products with tobacco or e-liquids. This study aims to determine and compare the levels of nicotine delivered to the bloodstream from nicotine salt and free-base nicotine e-liquid solutions.

Conditions

  • Nicotine Dependence

Interventions

DRUG

Nicotine

Vape Free-Low nicotine unflavored

DEVICE

Vaporizer Device

Take puffs from vaporizer filled with different flavors

DRUG

Salt-HIgh Nicotine Unflavored (Product B)

Vape Salt-High nicotine unflavored

DRUG

Free-Low Nicotine Tobacco Flavored (Product C)

Vape Free-Low Nicotine Tobacco

DRUG

Salt-High Nicotine Tobacco Flavored (Product D)

Vape Salt-High Tobacco

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Roswell Park Cancer Institute

    lead OTHER

Principal Investigators

  • Amanda Quisenberry · Roswell Park Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-18
Primary Completion
2024-07-10
Completion
2024-07-10

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04231539 on ClinicalTrials.gov