Nicotine Delivery From Novel Non-Tobacco Electronic System in Smokers

NCT02575885 | Completed

• 4 other identifiers: I 257514NCI-2015-01187P30CA016056R01DA037446
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Cigarette Smoker; Current Smoker; Healthy Subject

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• Changes in withdrawal symptoms

  Will be measured with Minnesota Withdrawal Scale

  up to 1 year

• Subjective nicotine effect will be analyzed

  Will be measured with Drug Effect Questionnaire

  up to 1 year

• Changes in feelings and emotions

  Will be measured with The Positive Negative Affect Scale

  up to 1 year

Secondary Outcomes (2)

• Amounts of nicotine present in various brands and types of ENDS (Study 3)

  Up to 1 year

• Nicotine yields in vapors from various types of ENDS under laboratory conditions (Study 4)

  Up to 1 year

Other Outcomes (5)

• maximum concentration of nicotine in plasma (Cmax) (Study 1 and Study 2)

  2 hours post using ENDS product

• The maximum concentration of nicotine in the area under the plasma concentration - time curve from 0 to 90 minutes (AUC)

  2 hours post using ENDS product

• The time to maximum concentration of nicotine in plasma (tmax)

  2 hours post using ENDS product

Study Arms (2)

Arm I (different type of ENDS product at each visit)

EXPERIMENTAL

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.

Other: Electronic Cigarette; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Other: Questionnaire Administration

Arm II (BLU e-cigarette ENDS product with different flavors)

EXPERIMENTAL

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.

Other: Electronic Cigarette; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Other: Questionnaire Administration

Interventions

Electronic Cigarette OTHER

Receive different type of ENDS product at each visit

Also known as: e-Cigarette, Electronic Nicotine Delivery System

Arm I (different type of ENDS product at each visit)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (different type of ENDS product at each visit); Arm II (BLU e-cigarette ENDS product with different flavors)

Pharmacological Study OTHER

Correlative studies

Arm I (different type of ENDS product at each visit); Arm II (BLU e-cigarette ENDS product with different flavors)

Questionnaire Administration OTHER

Ancillary studies

Arm I (different type of ENDS product at each visit); Arm II (BLU e-cigarette ENDS product with different flavors)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Related Publications (1)

• Voos N, Smith D, Kaiser L, Mahoney MC, Bradizza CM, Kozlowski LT, Benowitz NL, O'Connor RJ, Goniewicz ML. Effect of e-cigarette flavors on nicotine delivery and puffing topography: results from a randomized clinical trial of daily smokers. Psychopharmacology (Berl). 2020 Feb;237(2):491-502. doi: 10.1007/s00213-019-05386-x. Epub 2019 Nov 26.

  PMID: 31773209 DERIVED

MeSH Terms

Interventions

Electronic Nicotine Delivery Systems

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Martin Mahoney

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2015
• First Posted: October 15, 2015
• Study Start: March 16, 2016
• Primary Completion: June 6, 2018
• Study Completion: June 6, 2018
• Last Updated: June 12, 2018

Record last verified: 2018-06

Locations

US (1)