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

N/A

Waitlist Available

Led By Theodore L Wagener, PhD

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approx. 30 minutes

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if different types of e-liquids have different effects on how much nicotine people get from smoking e-cigarettes, how much they like it, and how harmful it is.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approx. 30 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approx. 30 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and approx. 30 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Drug Effects Liking Questionnaire (DEQ)

Exhaled breath carbon monoxide (CO)

Minnesota Nicotine Withdrawal Scale

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (pronated e-liquid, unprotonated e-liquidExperimental Treatment4 Interventions

VISIT 2: 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. 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 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

Group II: Arm II (unprotonated e-liquid, protonated e-liquidActive Control4 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cigarette Smoking

2022

Completed Early Phase 1

~80

Computed Tomography

2017

Completed Phase 2

~2790