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

Cigarette Smoking-Related Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05455086
• Other study ID #: OSU-21069
• Secondary ID: NCI-2021-05882
• Status: Completed
• Phase: N/A
• Start date: March 23, 2022
• Est. completion date: June 26, 2023

Study information

• Verified date: November 2023
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 26, 2023
• Est. primary completion date: June 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking-Related Carcinoma

Intervention

Behavioral:
• Cigarette Smoking
Receive 1 puff of tobacco flavored protonated e-liquid
• Cigarette Smoking
Receive 1 puff of unflavored protonated e-liquid
• Cigarette Smoking
Receive 1 puff of tobacco flavored unprotonated cigarette
• Cigarette Smoking
Receive 1 puff of unfavored unprotonated cigarette

Procedure:
• Computed Tomography
Undergo PET/CT
• Positron Emission Tomography
Undergo PET/CT

Other:
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PET/CT imaging of the head	Evaluate effect of nicotine form (free-base vs nicotine salt base) and concentration to determine nicotine absorption and distribution in the brain.	1.5 hours
Primary	PET/CT imaging of the chest	Evaluate effect of nicotine form (free-base vs nicotine salt base) and concentration to determine nicotine absorption and distribution in the raspatory tract.	1.5 hours
Primary	Puff volume	Puffing topography data will captured by the study E-Cig to determine the participant's typical puff volume.	approx. 30 minutes
Primary	Puff duration	Puffing topography data will captured by the study E-Cig to determine the participant's typical puff volume.	approx. 30 minutes
Primary	Tobacco use history questionnaire	Will assess years of tobacco use, age of first use, tobacco type, brand, frequency, quantity, and duration of use all of nicotine/tobacco products including cigars, cigarillos, little cigars, pipe tobacco, chewing tobacco, snuff, snus, EC/vape/mod/APV/e-hookah, and hookah tobacco.	approx. 5 minutes
Primary	Modified Cigarette Evaluation Questionnaire (mCEQ)	Modified 12-item Cigarette Dependence Scale will measure nicotine dependence.	approx. 5 minutes
Primary	Drug Effects Liking Questionnaire (DEQ)	Subjective effects and scaled questions. For scaled question the range is 1 to 5 with the lowest being the weekest and greatest being the strongest.	approx. 5 minutes
Primary	Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (modified)	Assess E-cig craving/suppression of craving and withdraw	aprox. 5 minutes
Primary	Minnesota Nicotine Withdrawal Scale	Evaluate the effects of smoking cessation. Range 0-4, from "none" to "severe".	approx. 5 minutes
Primary	Exhaled breath carbon monoxide (CO)	Collect before each scan with a handheld electrochemical device.	approx. 5 minutes

External Links

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