Nicotine Delivery From Novel Non-Tobacco Electronic System in Smokers

Healthy Subject Clinical Trial

— ENDS  

Official title:

Nicotine Delivery From Novel Non-tobacco Electronic Systems (ENDS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02575885
• Other study ID #: I 257514
• Secondary ID: NCI-2015-01187I
• Status: Completed
• Phase: N/A
• Start date: March 16, 2016
• Est. completion date: June 6, 2018

Study information

• Verified date: June 2018
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 6, 2018
• Est. primary completion date: June 6, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoker
• Current Smoker
• Healthy Subject

Intervention

Other:
• Electronic Cigarette
Receive different type of ENDS product at each visit
• Electronic Cigarette
Receive BLU e-cigarette ENDS product
• Laboratory Biomarker Analysis
Correlative studies
• Pharmacological Study
Correlative studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (3)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	National Cancer Institute (NCI), National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	maximum concentration of nicotine in plasma (Cmax) (Study 1 and Study 2)	Cmax will be analyzed using a repeated measures analysis of variance, including terms for gender , race and order of treatment	2 hours post using ENDS product
Other	The maximum concentration of nicotine in the area under the plasma concentration - time curve from 0 to 90 minutes (AUC)	AUC will be analyzed using a repeated measures analysis of variance, including terms for gender, race and order of treatment.	2 hours post using ENDS product
Other	The time to maximum concentration of nicotine in plasma (tmax)	tmax will be analyzed using a repeated measures analysis of variance, including terms for gender , race and order of treatment	2 hours post using ENDS product
Other	Estimated puff volume	Puff volume as determined with Cress Micro monitors	2 hours post using ENDS product
Other	Estimated puff duration	Puff duration as determined with Cress Micro monitors	2 hours post using ENDS product
Primary	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	The maximum concentration of nicotine in plasma (Cmax) will be determined for each product.	Up to 1 year
Primary	Levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes	Time to maximum concentration (Tmax) will be determined for each product .	Up to 1 year
Primary	Levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes	Area under the plasma concentration versus time curve (AUC) will be determined for each product.	up to 1 year
Primary	Changes in withdrawal symptoms	Will be measured with Minnesota Withdrawal Scale	up to 1 year
Primary	Subjective nicotine effect will be analyzed	Will be measured with Drug Effect Questionnaire	up to 1 year
Primary	Changes in feelings and emotions	Will be measured with The Positive Negative Affect Scale	up to 1 year
Secondary	Amounts of nicotine present in various brands and types of ENDS (Study 3)	Nicotine content (mean, median, minimum and maximum) will be determined for each product	Up to 1 year
Secondary	Nicotine yields in vapors from various types of ENDS under laboratory conditions (Study 4)	Nicotine yield in vapor will be determined for each product.	Up to 1 year