NCT05455086

Free-Base Nicotine or Nicotine Salt e-Liquids in Current E-Cigarette Smokers, PeloPET Study

Free-Base Nicotine or Nicotine Salt e-Liquids in Current E-Cigarette Smokers, PeloPET

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial studies the effect of free-base compared with nicotine salt based e-liquids on electronic cigarette (EC) puffing behavior, abuse liability, and deposition and absorption of nicotine in the respiratory tract and rate of uptake in the brain in current EC smokers. The results from this study may provide much needed scientific information to public health officials and regulators.

Detailed description

PRIMARY OBJECTIVES: I. To examine the influence of nicotine form on puffing behavior and abuse liability. II. To evaluate the influence of nicotine form and concentration on nicotine distribution in the brain and respiratory tract. OUTLINE: VISIT 1: Patients sample 4-liquids to determine whether they can vape the unflavored e-liquid without coughing Patients are randomized to 1 of 2 arms. ARM I: VISIT 2: Patients receive 1 puff of tobacco flavored or unflavored protonated e-liquid and undergo 0-15 minutes (min) head and 5 min chest positron emission tomography (PET)/computed tomography (CT) and then 0-15 min chest and 5 min head PET/CT. About 2 hours post initial PET/CT, patients receive a second puff of tobacco flavored or unflavored protonated e-liquid and undergo 0-15 min chest and 5 min head PET/CT and then 0-15 min head and 5 min chest PET/CT. VISIT 3: Patients receive 1 puff of tobacco flavored or unflavored unprotonated e-liquid and undergo 0-15 min head and 5 min chest PET/CT and then 0-15 min chest and 5 min head PET/CT. About 2 hours post initial PET/CT, patients receive a second puff of tobacco flavored or unflavored unprotonated e-liquid and undergo 0-15 min chest and 5 min head PET/CT and then 0-15 min head and 5 min chest ARM II: VISIT 2: Patients receive 1 puff of tobacco flavored or unflavored unprotonated e-liquid and undergo 0-15 min head and 5 min chest PET/CT and then 0-15 min chest and 5 min head PET/CT. About 2 hours post initial PET/CT, patients receive a second puff of tobacco flavored or unflavored unprotonated e-liquid and undergo 0-15 min chest and 5 min head PET/CT and then 0-15 min head and 5 min chest. VISIT 3: Patients receive 1 puff of tobacco flavored or unflavored protonated e-liquid and undergo 0-15 min head and 5 min chest PET/CT and then 0-15 min chest and 5 min head PET/CT. About 2 hours post initial PET/CT, patients receive a second puff of tobacco flavored or unflavored protonated e-liquid and undergo 0-15 min chest and 5 min head PET/CT and then 0-15 min head and 5 min chest PET/CT.

Conditions

• Cigarette Smoking-Related Carcinoma

Interventions

Type	Name	Description
BEHAVIORAL	Cigarette Smoking	Receive 1 puff of tobacco flavored protonated e-liquid
BEHAVIORAL	Cigarette Smoking	Receive 1 puff of unflavored protonated e-liquid
BEHAVIORAL	Cigarette Smoking	Receive 1 puff of tobacco flavored unprotonated cigarette
BEHAVIORAL	Cigarette Smoking	Receive 1 puff of unfavored unprotonated cigarette
PROCEDURE	Computed Tomography	Undergo PET/CT
PROCEDURE	Positron Emission Tomography	Undergo PET/CT
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2022-03-23
• Primary completion: 2023-06-26
• Completion: 2023-06-26
• First posted: 2022-07-13
• Last updated: 2025-03-24
• Results posted: 2025-03-24

Locations

1 site across 1 country: United States