BIDI Stick ENDS Abuse Liability and Puffing Topography Assessment

NCT05072925 | Completed

• 1 other identifier: BIDI-PK-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This study assessed the abuse liability (measured by assessing how much nicotine enters the body when the BIDI Stick is used, and how this makes users feel) and puffing topography (puff characteristics like volume and duration) of the BIDI Stick ENDS, a type of electronic cigarette.

Conditions

E-cigarette Use; Cigarette Smoking

Outcome Measures

Primary Outcomes (11)

• Baseline-adjusted plasma nicotine Cmax0-120

  Maximum baseline-adjusted plasma concentration of nicotine from time zero to 120 minutes after the start of product use

  0-120 minutes

• Baseline-adjusted plasma nicotine Tmax0-120

  Baseline-adjusted plasma nicotine Tmax following defined product use

  0-120 minutes

• Baseline-adjusted plasma nicotine AUC0-120

  Baseline-adjusted area under the plasma nicotine concentration-versus-time curve from time zero to 120 minutes after the start of product use

  0-120 minutes

• Baseline-adjusted plasma nicotine Cmax0-180

  Maximum baseline-adjusted plasma concentration of nicotine from time zero to 180 minutes after the start of product use

  0-180 minutes

• Baseline-adjusted plasma nicotine Tmax0-180

  Baseline-adjusted plasma nicotine Tmax following both defined and ad libitum product use

  0-180 minutes

• Baseline-adjusted plasma nicotine AUC0-180

  Baseline-adjusted area under the plasma nicotine concentration-versus-time curve from time zero to 180 minutes after the start of product use

  0-180 minutes

• Product liking

  Visual analog scale product liking assessment; scale from 0 to 100 with higher scores representing stronger liking.

  180 minutes

• Intent to Use Product Again

  Visual analog scale intent to use product again assessment; scale from 0 to 100 with higher scores representing stronger intent to use the product again.

  180 minutes

• Urge to Smoke

  Visual analog scale urge to smoke assessment; scale from 0 to 100 with higher scores representing stronger urge to smoke.

  0-180 minutes

• Product Evaluation Scale

  Subjective effects assessment using Product Evaluation Scale, which included 21 items with responses recorded on a scale of 1 to 7 ranging from 'Not at all' to 'Extremely'.

  180 minutes

• Mass change

  Mass change in grams of ENDS products during use sessions

  0-5 minutes and 120-180 minutes

Secondary Outcomes (5)

• Puff duration

  120-180 minutes

• Puff volume

  120-180 minutes

• Peak puff flow rate

  120-180 minutes

• Average puff flow rate

  120-180 minutes

• Inter-puff interval

  120-180 minutes

Other Outcomes (3)

• Heart rate

  0-180 minutes

• Blood pressure

  0-180 minutes

• Adverse events

  From screening through study completion, an average of 1 month

Study Arms (8)

Combustible Cigarette

ACTIVE COMPARATOR

The usual brand of combustible cigarette smoked by study subjects, with a minimum Federal Trade Commission tar yield of 8mg

Other: Tobacco products

BIDI Stick ENDS Arctic flavor

EXPERIMENTAL

BIDI Stick ENDS containing 6% nicotine and Arctic flavor

Other: Tobacco products

BIDI Stick ENDS Classic flavor

EXPERIMENTAL

BIDI Stick ENDS containing 6% nicotine and Classic flavor

Other: Tobacco products

BIDI Stick ENDS Zest flavor

EXPERIMENTAL

BIDI Stick ENDS containing 6% nicotine and Zest flavor

Other: Tobacco products

BIDI Stick ENDS Regal flavour

EXPERIMENTAL

BIDI Stick ENDS containing 6% nicotine and Regal flavor

Other: Tobacco products

BIDI Stick ENDS Winter flavour

EXPERIMENTAL

BIDI Stick ENDS containing 6% nicotine and Winter flavor

Other: Tobacco products

BIDI Stick ENDS Solar flavor

EXPERIMENTAL

BIDI Stick ENDS containing 6% nicotine and Solar flavor

Other: Tobacco products

JUUL ENDS Virginia Tobacco flavor

ACTIVE COMPARATOR

JUUL ENDS containing 5% nicotine and Virginia Tobacco flavor

Other: Tobacco products

Interventions

Tobacco products OTHER

Products will be used under defined (10 puffs, 30 seconds apart) and ad libitum puffing conditions

BIDI Stick ENDS Arctic flavor; BIDI Stick ENDS Classic flavor; BIDI Stick ENDS Regal flavour; BIDI Stick ENDS Solar flavor; BIDI Stick ENDS Winter flavour; BIDI Stick ENDS Zest flavor; Combustible Cigarette; JUUL ENDS Virginia Tobacco flavor

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy males or females within the ages of 21 to 65 years, inclusive.
• Subjects will have a body mass index (BMI) of 18.5 to 35.0 kg/m2, inclusive, and a body weight exceeding 52 kg (males) or 45 kg (females).
• Subjects must be current smokers (≥10 per day) of factory-made, high tar (10mg) combustible cigarettes (eCO \>10 ppm at screening) for at least one continuous year before Visit 1 and may be occasional or dual users of e-cigarettes.
• Urine cotinine \>200 ng/mL.
• Subject demonstrates understanding of the study and willingness/consent to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the consent form.
• Subject understands and is willing, able, and likely to comply with all the study procedures and restrictions.
• Subject is in good general health in the opinion of the investigator, with no clinically significant and relevant abnormalities of medical history (e.g., uncontrolled hypertension, recent myocardial infarction or unstable angina, history of seizures or recent stomach ulcer).
• Subject has a seated systolic blood pressure ≤160 mmHg, diastolic blood pressure ≤95 mmHg, and heart rate ≤100 bpm.
• Females of childbearing potential are, in the opinion of the investigator, practicing a reliable method of contraception.

You may not qualify if:

• Subjects who, in the judgment of the study physician, have recent or active COVID 19 infection, as evidenced by the following:
• Endorsement of symptoms that could indicate COVID-19 during screening (Section 13.1) and/or
• Body temperature ≥38.0°C and/or
• Laboratory test results suggestive of active or recent exposure to SARS-CoV-2 (Section 9.4).
• Laboratory serology results positive for HBsAg, hepatitis C virus (HCV) antibody, (HIV) type 1 or 2.
• Subjects who have participated in another clinical study within 30 days of Visit 1 or who have previously participated in this study.
• Subjects who have an acute illness (e.g., upper respiratory tract infection, viral infection) requiring treatment in the 4 weeks prior to Visit 1, or an active respiratory infection at time of the Screening Visit.
• Subject has a clinically significant abnormal finding on the physical examination, medical history, vital signs, ECG, lung x-ray or clinical laboratory results that could interfere with, or for which use of the study products might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.
• Subjects who have used any nicotine or tobacco product other than e-cigarettes or factory-made combustible cigarettes in the 14 days prior to the Visit 1.
• Subjects who are self-reported or observed (during the trial session at Visit 2) non inhalers during ENDS/cigarette use.
• Subjects who have used any prescription or over-the-counter (OTC) smoking cessation treatments, including, but not limited to any form of nicotine replacement therapy (NRT), varenicline, cytisine, or bupropion within 30 days prior to Visit 1.
• Is planning to quit smoking during the study or postponing a quit attempt in order to participate in the study.
• Subjects who have used prescription or OTC bronchodilator medication (e.g., inhaled or oral β adrenergic agonists, anticholinergics, glucocorticoids, cromones, or theophylline) to treat a chronic condition within the 12 months prior to Visit 1 or have a history of lung disease.
• Subjects who have received any medications or substances that interfere with the cyclooxygenase pathway within 14 days prior to Visit 1 or are known to be strong inducers or inhibitors of cytochrome P450 (CYP) enzymes within 14 days or 5 half lives of the drug (whichever is longer) prior to Visit 1.
• Women who are pregnant or who have a positive urine pregnancy test.

Sponsors & Collaborators

• BIDI Vapor: lead

Study Sites (1)

MTZ Clinical Research Sp. z o.o.

Warsaw, 02-106, Poland

Location

Related Publications (1)

• Fearon IM, Gilligan K, Seltzer RGN, McKinney W. A randomised, crossover, clinical study to assess nicotine pharmacokinetics and subjective effects of the BIDI(R) stick ENDS compared with combustible cigarettes and a comparator ENDS in adult smokers. Harm Reduct J. 2022 Jun 2;19(1):57. doi: 10.1186/s12954-022-00638-0.

  PMID: 35655314 DERIVED

MeSH Terms

Conditions

Vaping; Cigarette Smoking

Interventions

Tobacco Products

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Smoking; Tobacco Use

Intervention Hierarchy (Ancestors)

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

Study Officials

• Anna O Popko, MD

  MTZ Clinical Research Sp z.o.o.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2021
• First Posted: October 11, 2021
• Study Start: July 7, 2021
• Primary Completion: July 23, 2021
• Study Completion: July 23, 2021
• Last Updated: October 11, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)