Nicotine Delivery From Novel Non-Tobacco Electronic System in Smokers

Not Applicable

Completed

• Conditions: Healthy Subject; Cigarette Smoker; Current Smoker
• Interventions: Other: Electronic Cigarette; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Other: Questionnaire Administration

• Registration Number: NCT02575885
• Lead Sponsor: Roswell Park Cancer Institute

Brief Summary

This randomized pilot clinical trial studies nicotine delivery from novel non-tobacco electronic system (ENDS) in smokers. Studying the levels of nicotine delivered by various types and brands of ENDS to the bloodstream, and comparing this to the levels delivered from conventional cigarettes (the participant's own brand) may help provide information about the use of nicotine-containing products that may help inform/reform current tobacco policy, practice, and harm reduction approaches.

Detailed Description

PRIMARY OBJECTIVES:

I. Determine the levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes. (Study 1)

II. Explore the effect of flavorings added to nicotine solution on puffing topography and nicotine delivery and, assess and compare short-term "functional" nicotine effects of the different products by using subjective measures such as relief of craving and withdrawal symptoms. (Study 2)

SECONDARY OBJECTIVES:

I. Determine the amounts of nicotine present in various brands and types of ENDS. (Study 3)

II. Determine nicotine yields in vapors from various types of ENDS under laboratory conditions. (Study 4)

TERTIARY OBJECTIVES:

I. Develop a standardized testing protocol for ENDS that will reflect users' puffing behavior and product characteristics.

II. Develop and validate the analytical method for analysis of nicotine content in the vapor.

III. Propose a standardized puffing regimen for generating vapors for analytical purposes: Such a testing protocol will reflect the puffing behavior observed among ENDS users and should be specific to ENDS type.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I (Study 1): Participants are asked to smoke ad lib a single cigarette of their own brand and provided with a different type of ENDS product at each visit (e-cigarette, disposable e-cigarette, eGo, personal vaporizer, e-cigar, and e-pipe) over 3.5-4 hours at least 7 days apart for 7 weeks. Participants are provided with cartridges of the same amounts of nicotine with regular (tobacco) or menthol flavor according to smoker's preference, instructed on how to use the product, asked to practice using it for 7 days, and return to the study center for their next visit.

ARM II (Study 2): Participants are asked to smoke ad lib a single cigarette of their own brand and provided with the BLU e-cigarette ENDS product with nicotine solution of one of five flavors over 3.5-4 hours at least 7 days apart for 6 weeks. Participants are provided with cartridges of maximum available amounts of nicotine and different flavors at each visit, instructed on how to use the product, asked to practice using it for 7 days, and return to the study center for their next visit.

Study Timeline

• Study First Submitted: 2015-08-06
• Study First Submitted QC: 2015-10-13
• Study First Posted: 2015-10-15
• Study Start: 2016-03-16
• Status Verified: 2018-06
• Primary Completion: 2018-06-06
• Study Completion: 2018-06-06
• Last Update Submitted: 2018-06-11
• Last Update Posted: 2018-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Healthy on the basis of medical history

• Current moderate-to-heavy smoker as determined by:

  • Has smoked >=10 cigarettes per day regularly for the past year (by history) and (>=5 cigarettes per day Study 2 ONLY)
  • Has an expired carbon monoxide (CO) at screening visit of 8 parts per million (ppm) or more (6 ppm or more Study 2 ONLY)

• Nicotine dependence assessed as > 4 with the Fagerstrom Test for Nicotine Dependence

• Willingness to abstain from smoking for 8 hours (overnight abstinence) prior to study visits

• Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria

• Unstable medical conditions (such as unstable heart disease, uncontrolled hypertension, thyroid disease, diabetes, renal or liver impairment, glaucoma, or prostatic hypertrophy) or psychiatric condition (such as current major depression, history of schizophrenia or bipolar disorder, or current regular use of psychiatric medications such as major tranquilizers and antidepressants
• Pregnancy or lactation (by history) or positive pregnancy test at screening visit
• Positive urine drug test at screening visit
• History of serious side effects from nicotine or from any nicotine replacement therapies
• Alcohol or illicit drug dependence within the past 12 months (by history and urine tests)
• Concurrent participation in another clinical trial
• Unable to communicate in English
• Unwilling or unable to follow protocol requirements
• Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (different type of ENDS product at each visit)	Electronic Cigarette	Participants are asked to smoke ad lib a single cigarette of their own brand and provided with a different type of ENDS product at each visit (e-cigarette, disposable e-cigarette, eGo, personal vaporizer, e-cigar, and e-pipe) over 3.5-4 hours at least 7 days apart for 7 weeks. Participants are provided with cartridges of the same amounts of nicotine with regular (tobacco) or menthol flavor according to smoker's preference, instructed on how to use the product, asked to practice using it for 7 days, and return to the study center for their next visit.
Arm II (BLU e-cigarette ENDS product with different flavors)	Laboratory Biomarker Analysis	Participants are asked to smoke ad lib a single cigarette of their own brand and provided with the BLU e-cigarette ENDS product with nicotine solution of one of five flavors over 3.5-4 hours at least 7 days apart for 6 weeks. Participants are provided with cartridges of maximum available amounts of nicotine and different flavors at each visit, instructed on how to use the product, asked to practice using it for 7 days, and return to the study center for their next visit.
Arm II (BLU e-cigarette ENDS product with different flavors)	Questionnaire Administration	Participants are asked to smoke ad lib a single cigarette of their own brand and provided with the BLU e-cigarette ENDS product with nicotine solution of one of five flavors over 3.5-4 hours at least 7 days apart for 6 weeks. Participants are provided with cartridges of maximum available amounts of nicotine and different flavors at each visit, instructed on how to use the product, asked to practice using it for 7 days, and return to the study center for their next visit.
Arm II (BLU e-cigarette ENDS product with different flavors)	Electronic Cigarette	Participants are asked to smoke ad lib a single cigarette of their own brand and provided with the BLU e-cigarette ENDS product with nicotine solution of one of five flavors over 3.5-4 hours at least 7 days apart for 6 weeks. Participants are provided with cartridges of maximum available amounts of nicotine and different flavors at each visit, instructed on how to use the product, asked to practice using it for 7 days, and return to the study center for their next visit.
Arm II (BLU e-cigarette ENDS product with different flavors)	Pharmacological Study	Participants are asked to smoke ad lib a single cigarette of their own brand and provided with the BLU e-cigarette ENDS product with nicotine solution of one of five flavors over 3.5-4 hours at least 7 days apart for 6 weeks. Participants are provided with cartridges of maximum available amounts of nicotine and different flavors at each visit, instructed on how to use the product, asked to practice using it for 7 days, and return to the study center for their next visit.
Arm I (different type of ENDS product at each visit)	Laboratory Biomarker Analysis	Participants are asked to smoke ad lib a single cigarette of their own brand and provided with a different type of ENDS product at each visit (e-cigarette, disposable e-cigarette, eGo, personal vaporizer, e-cigar, and e-pipe) over 3.5-4 hours at least 7 days apart for 7 weeks. Participants are provided with cartridges of the same amounts of nicotine with regular (tobacco) or menthol flavor according to smoker's preference, instructed on how to use the product, asked to practice using it for 7 days, and return to the study center for their next visit.
Arm I (different type of ENDS product at each visit)	Questionnaire Administration	Participants are asked to smoke ad lib a single cigarette of their own brand and provided with a different type of ENDS product at each visit (e-cigarette, disposable e-cigarette, eGo, personal vaporizer, e-cigar, and e-pipe) over 3.5-4 hours at least 7 days apart for 7 weeks. Participants are provided with cartridges of the same amounts of nicotine with regular (tobacco) or menthol flavor according to smoker's preference, instructed on how to use the product, asked to practice using it for 7 days, and return to the study center for their next visit.
Arm I (different type of ENDS product at each visit)	Pharmacological Study	Participants are asked to smoke ad lib a single cigarette of their own brand and provided with a different type of ENDS product at each visit (e-cigarette, disposable e-cigarette, eGo, personal vaporizer, e-cigar, and e-pipe) over 3.5-4 hours at least 7 days apart for 7 weeks. Participants are provided with cartridges of the same amounts of nicotine with regular (tobacco) or menthol flavor according to smoker's preference, instructed on how to use the product, asked to practice using it for 7 days, and return to the study center for their next visit.

Primary Outcome Measures

Name	Time	Method
Determine Levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes	Up to 1 year	The maximum concentration of nicotine in plasma (Cmax) will be determined for each product.
Changes in withdrawal symptoms	up to 1 year	Will be measured with Minnesota Withdrawal Scale
Subjective nicotine effect will be analyzed	up to 1 year	Will be measured with Drug Effect Questionnaire
Changes in feelings and emotions	up to 1 year	Will be measured with The Positive Negative Affect Scale
Levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes	up to 1 year	Area under the plasma concentration versus time curve (AUC) will be determined for each product.

Secondary Outcome Measures

Name	Time	Method
Amounts of nicotine present in various brands and types of ENDS (Study 3)	Up to 1 year	Nicotine content (mean, median, minimum and maximum) will be determined for each product
Nicotine yields in vapors from various types of ENDS under laboratory conditions (Study 4)	Up to 1 year	Nicotine yield in vapor will be determined for each product.

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States