CSD200907: A Study to Assess Elements of Abuse Liability for a Heated Tobacco Product With Four Non-Combusted Cigarette Variants

NCT05114863 | Completed

• 1 other identifier: CSD200907
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, open-label, randomized, 2-arm, within-arm cross-over study designed to evaluate elements of abuse liability (AL) including subjective effects and physiological measures (pharmacodynamics \[PD\]), and plasma nicotine uptake (pharmacokinetics \[PK\]) during and following ad libitum use of the study investigational products (IPs) by generally healthy smokers.

Conditions

Smoking; Smoking Behaviors; Tobacco Use; Tobacco Smoking

Outcome Measures

Primary Outcomes (2)

• AUECPL 5-240

  area-under-the-effects curve (AUEC) for PL numeric rating scale (NRS) score-versus-time curve from 5 minutes to 240 minutes after the start of IP use.

  5 minutes to 240 minutes

• Emax PL

  maximum product liking (PL) numeric rating scale (NRS) score after the start of IP use.

  240 minutes

Study Arms (2)

Non-menthol smokers

EXPERIMENTAL

Subjects will be randomized to one of ten product use sequences, such that one of the five IPs (A1,B,C,D,N) will be used in each of the five Test Sessions.

Other: Product A1; Other: Product B; Other: Product C; Other: Product D; Other: Product N

Menthol smokers

EXPERIMENTAL

Subjects will be randomized to one of six product use sequences, such that one of the six IPs (A2,E,F,G,H,N) will be used in each of the six Test Sessions.

Other: Product A2; Other: Product E; Other: Product F; Other: Product G; Other: Product H; Other: Product N

Interventions

Product A1 OTHER

Usual Brand (UB) filtered, non-menthol cigarette

Non-menthol smokers

Product B OTHER

40007388, A Non-Combusted Cigarette Variant and product use Mode A

Non-menthol smokers

Product C OTHER

40007388, A Non-Combusted Cigarette Variant and product use Mode B

Non-menthol smokers

Product D OTHER

40007386, A Non-Combusted Cigarette Variant and product use Mode B

Non-menthol smokers

Product A2 OTHER

Usual Brand (UB) filtered, menthol cigarette

Menthol smokers

Product E OTHER

40007385, A Non-Combusted Cigarette Variant and product use Mode A

Menthol smokers

Product F OTHER

40007385, A Non-Combusted Cigarette Variant and product use Mode B

Menthol smokers

Product G OTHER

40007387, A Non-Combusted Cigarette Variant and product use Mode B

Menthol smokers

Product H OTHER

40007386, A Non-Combusted Cigarette Variant and product use Mode B

Menthol smokers

Product N OTHER

Nicorette® White Ice Mint 4 mg nicotine gum

Menthol smokers; Non-menthol smokers

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English.
• Generally healthy males or females, 21 to 60 years of age, inclusive, at the time of consent.
• Smokes combustible, filtered, non-menthol or menthol cigarettes, 83 mm to 100 mm in length. Smokers that also use other tobacco products (e.g., ENDS, smokeless tobacco, heated tobacco products) will not be excluded from study participation.
• Smokes an average of at least 10 cigarettes per day (CPD) and inhales the smoke, for at least 6 months prior to Screening. Brief periods of abstinence due to illness, quit attempt (prior to 30 days of Screening), or clinical study participation (prior to 30 days of Screening) will be allowed at the discretion of the PI.
• Agrees to smoke the same UB cigarette throughout the study period. The UB cigarette is defined as the reported cigarette brand style currently smoked most frequently by the subject.
• Expired breath carbon monoxide (ECO) level is ≥ 10 ppm and ≤ 100 ppm at Screening and at check-in Day 1.
• Positive urine cotinine test at Screening.
• Response at Screening to the Fagerström Test for Nicotine Dependence (FTND) Question 1 ("How soon after you wake up do you smoke your first cigarette?") is either "Within 5 minutes" or "6-30 minutes".
• Willing to use UB cigarette, HTP IPs, and Nicorette nicotine gum during the study period.
• Willing to abstain from tobacco and nicotine use for at least 12 hours prior to the start of each Test Session (either 5 or 6 sessions depending on the Study Arm).
• Females must be willing to use a form of contraception acceptable to the PI from the time of signing the informed consent until End-of-Study.
• Agrees to an in-clinic confinement of 11 days (10 nights) for Study Arm 1 -or- 13 days (12 nights) for Study Arm 2.

You may not qualify if:

• Presence of clinically significant uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, psychiatric, hematological, neurological disease, or any other concurrent disease or medical condition that, in the opinion of the PI, makes the study subject unsuitable to participate in this clinical study.
• History, presence of, or clinical laboratory test results indicating diabetes.
• Scheduled treatment for asthma currently or within the past consecutive 12 months prior to the Screening Visit. As-needed treatment, such as inhalers, may be included at the PI's discretion pending approval from the Medical Monitor.
• History or presence of bleeding or clotting disorders.
• Any history of cancer, except for primary cancers of skin such as localized basal cell/squamous cell carcinoma that has been surgically and/or cryogenically removed.
• Systolic blood pressure of \> 160 mmHg or a diastolic blood pressure of \> 95 mmHg, measured after being seated for five minutes at Screening and at check-in Day 1.
• Weight of ≤ 110 pounds.
• Hemoglobin level is \< 12.5 g/dL for females or \< 13.0 for males g/dL at Screening.
• Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the course of the study.
• A positive urine drug screen without evidence of prescribed corresponding concomitant medication(s) at Screening or check-in Day 1.
• Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
• Use of any medication or substance that aids in smoking cessation, including but not limited to any nicotine replacement therapy (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract within (≤) 30 days prior to signing the ICF.
• Postpones a decision to quit using tobacco- or nicotine-containing products in order to participate in this study or self-reports a previous attempt within (≤) 30 days prior to signing the ICF.
• Any use of aspirin (≥ 325 mg/day) or anticoagulants.
• Individuals ≥ 35 years of age currently using systemic, estrogen-containing contraception or hormone replacement therapy.

Sponsors & Collaborators

• RAI Services Company: lead

Study Sites (1)

AMR Knoxville

Knoxville, Tennessee, 37920, United States

Location

Related Publications (1)

• Kanobe MN, Makena P, Prevette K, Baxter SA. Assessment of Abuse Liability and Nicotine Pharmacokinetics of glo Heated Tobacco Products in a Randomized, Crossover Study. Eur J Drug Metab Pharmacokinet. 2024 Nov;49(6):733-750. doi: 10.1007/s13318-024-00921-4. Epub 2024 Oct 25.

  PMID: 39453550 DERIVED

MeSH Terms

Conditions

Smoking; Tobacco Use; Tobacco Smoking

Interventions

HTR3D protein, human

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Milly Kanobe, PhD

  RAIS

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 10, 2021
• Study Start: November 29, 2021
• Primary Completion: February 27, 2022
• Study Completion: February 27, 2022
• Last Updated: June 27, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)