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

The Ohio State University

Status

Completed

Conditions

Cigarette Smoking-Related Carcinoma

Treatments

Procedure: Computed Tomography

Behavioral: Cigarette Smoking

Procedure: Positron Emission Tomography

Other: Questionnaire Administration

Study type

Interventional

Funder types

Other

Identifiers

NCT05455086

OSU-21069

NCI-2021-05882 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

21 patients

Sex

All

Ages

21 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

A current exclusive e-cigarette user (>= 1 vaping bout per day) for at least the past 6 months (confirmed by NicAlert saliva testing strip)
Between 21-50 years old
Willing to provide informed consent and abstain from all tobacco and nicotine use for at least 12 hours prior to visits 2 and 3
Willing to participate in 3 laboratory visits
Read and speak English
If utilizing study provided rideshare services, will need to live within 20 miles of Wake Forest University

Exclusion criteria

Self-reported diagnosis of lung disease including asthma, cystic fibrosis, or chronic obstructive pulmonary disease
Unstable or significant psychiatric conditions (past and stable conditions will be allowed)
History of cardiac event or distress within the past 3 months
Currently pregnant (as indicated by urine pregnancy test at the start of each laboratory visit), planning to become pregnant, or breastfeeding (women only)
Use of other tobacco products (e.g., cigarette, cigar, etc.) > 5 days in the past month
Currently engaging in a tobacco product cessation attempt

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

21 participants in 2 patient groups

Arm I (pronated e-liquid, unprotonated e-liquid

Experimental group

Description:

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

Treatment:

Behavioral: Cigarette Smoking

Other: Questionnaire Administration

Procedure: Positron Emission Tomography

Behavioral: Cigarette Smoking

Procedure: Computed Tomography

Arm II (unprotonated e-liquid, protonated e-liquid

Active Comparator group

Description:

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:

Behavioral: Cigarette Smoking

Other: Questionnaire Administration

Procedure: Positron Emission Tomography

Behavioral: Cigarette Smoking

Procedure: Computed Tomography

Trial documents