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Completed

NCT Number: NCT06093659

Nicotine Pharmacokinetic Study of Heated Tobacco and Heated Herbal Products

This is a randomised, cross-over, open-label, confinement study conducted in 25 adult male or female smokers of combustible cigarettes (CCs). The study investigates combustible cigarettes, heated tobacco products (HTPs), and Heated Herbal Products (HHPs), with endpoints including pharmacokinetic evaluation, and subjective effects.

Subjects will perform a Screening Visit and one Study Visit, including a 6-day confinement period.

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Key information

Conditions

Healthy Volunteers

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Celerion

Belfast, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Reports smoking an average of at least 10 manufactured combustible (menthol or non-menthol) cigarettes per day for at least 12 months prior to Screening
  • Has a positive urine cotinine (>500 ng/mL) at Screening
  • Has an exhaled carbon monoxide >10 ppm at Screening
  • Female subjects of childbearing potential must use contraception
  • Male subjects must use contraception

Exclusion criteria

  • Has a history or presence of clinically significant disease or condition that, in the opinion of the Investigator, would jeopardise the safety of the subject or impact the validity of the study results.
  • Has a positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at Screening
  • Has a body mass index (BMI) > 30.0 kg/m^2 or < 18.0 kg/m^2 at Screening
  • Has a fever (>38.05°C) at Screening or check-in
  • Has a history or presence of drug or alcohol abuse within 24 months of Check-in
  • Pregnant or lactating females
  • Has used any prescription smoking cessation treatments within 3 months prior to Check-in Is planning to quit smoking during the study or within the next 3 months

Treatment and study plan

Heated tobacco product with heated tobacco sticks (Product A)

Other

Product A, used under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration), followed by an ad-libitum, 4-hour product use session on the same day.

Heated tobacco product with heated tobacco sticks (Product B)

Other

Product B, used under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration), followed by an ad-libitum, 4-hour product use session on the same day.

Heated herbal product with nicotine-infused heated herbal sticks (Product C)

Other

Product C, used under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration), followed by an ad-libitum, 4-hour product use session on the same day.

Heated herbal product with nicotine-infused heated herbal sticks (Product D)

Other

Product D, used under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration), followed by an ad-libitum, 4-hour product use session on the same day.

Conventional Cigarette (Product E)

Other

Subject's own brand combustible cigarette used under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration), followed by an ad-libitum, 4-hour product use session on the same day.

Primary outcomes

  1. Nicotine Cmax

    Time frame: 5 minutes pre-study product use and at 2, 4, 6, 8, 10, 15, 30, 45, 60, 120, and 240 minutes following the start of study product use

    Maximum measured plasma nicotine concentration, following the controlled product use session

  2. Nicotine AUCt

    Time frame: 5 minutes pre-study product use and at 2, 4, 6, 8, 10, 15, 30, 45, 60, 120, and 240 minutes following the start of study product use

    The area under the concentration time curve for nicotine, from time 0 to the last observed non-zero concentration, following the controlled product use session

Secondary outcomes

  1. Urge to Smoke Pre-use

    Time frame: 10 minutes prior to the start of the product use session

    The subjects self-assess their urge to smoke by answering the question: "Right now, how much would you like to smoke a cigarette?" on a Visual Analog Scale (VAS), with scores of 0 to 100, with 0 being 'not at all' and 100 being 'a great deal'.

  2. Urge to Smoke Post-use

    Time frame: At 240 minutes following the start of study product use

    The subjects self-assess their urge to smoke by answering the question: "Right now, how much would you like to smoke a cigarette?" on a Visual Analog Scale (VAS), with scores of 0 to 100, with 0 being 'not at all' and 100 being 'a great deal'.

  3. Urge to Smoke Emax

    Time frame: 10 minutes prior to the start of the product use session and at 2, 4, 6, 8, 10, 15, 30, 45, 60, 120, and 240 minutes following the start of study product use.

    The subjects self-assess their urge to smoke at defined time points by answering the question: "Right now, how much would you like to smoke a cigarette?" on a Visual Analog Scale (VAS), with scores of 0 to 100, with 0 being 'not at all' and 100 being 'A great deal'. Emax is calculated as the maximum absolute value of change from baseline (pre-use) (i.e., the maximum response) in VAS scores.

  4. Puff Count

    Time frame: Hours 2-4 of the 4-hour ad libitum product use session

    Number of puffs taken during last 2 hours of the 4-hour ad-libitum product use session

Sponsors and collaborators

Lead sponsor

Imperial Brands PLC

Industry

Registry information

Official study title

A Randomised, Cross-Over, Nicotine Pharmacokinetic and Pharmacodynamic Study of Heated Tobacco and Heated Herbal Products Compared With Combustible Cigarettes

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 23, 2023
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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