CSD201201: Study to Assess Elements of Abuse Liability for Electronic Nicotine Delivery System P12

NCT05210699 | Completed

• 1 other identifier: CSD201201
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

This is a randomized, open-label, 6-way crossover, multi-site study designed to evaluate elements of abuse liability (AL) including subjective effects and physiological measures (pharmacodynamics \[PD\]), and nicotine uptake (pharmacokinetics \[PK\]) during and following ad libitum use of the Electronic Nicotine Delivery Systems (ENDS) investigational products (IPs) in generally healthy combustible cigarette (CC) smokers and dual users of CC and ENDS.

Conditions

Smoking; Smoking Behaviors; Tobacco Use; Tobacco Smoking

Outcome Measures

Primary Outcomes (2)

• AUECPL 3-240

  area-under-the-effects curve (AUEC) for product liking (PL) numeric rating scale (NRS) score-versus-time curve from 3 minutes to 240 minutes after the start of IP use. Product Liking is a numeric rating scale ranging from 0 to 10. A higher score indicates a higher liking of the product.

  5 minutes to 240 minutes

• Emax PL

  maximum product liking (PL) numeric rating scale (NRS) score after the start of IP use. Product Liking is a numeric rating scale ranging from 0 to 10. A higher score indicates a higher liking of the product.

  240 minutes

Study Arms (6)

Product usage order A B N C E D

EXPERIMENTAL

Subjects will use each of the 5 products sequentially (A B N C E D) during an evaluation period, followed by a 4 hour Test Session.

Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product N

Product usage order B C A D N E

EXPERIMENTAL

Subjects will use each of the 5 products sequentially (B C A D N E) during an evaluation period, followed by a 4 hour Test Session.

Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product N

Product usage order C D B E A N

EXPERIMENTAL

Subjects will use each of the 5 products sequentially (C D B E A N) during an evaluation period, followed by a 4 hour Test Session.

Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product N

Product usage order D E C N B A

EXPERIMENTAL

Subjects will use each of the 5 products sequentially (D E C N B A) during an evaluation period, followed by a 4 hour Test Session.

Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product N

Product usage order E N D A C B

EXPERIMENTAL

Subjects will use each of the 5 products sequentially (E N D A C B) during an evaluation period, followed by a 4 hour Test Session.

Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product N

Product usage order N A E B D C

EXPERIMENTAL

Subjects will use each of the 5 products sequentially (N A E B D C) during an evaluation period, followed by a 4 hour Test Session.

Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product N

Interventions

Product A OTHER

Usual Brand (UB) filtered, menthol combustible cigarette

Product usage order A B N C E D; Product usage order B C A D N E; Product usage order C D B E A N; Product usage order D E C N B A; Product usage order E N D A C B; Product usage order N A E B D C

Product B OTHER

Flavor variant P1211216 of a 1.5% nicotine ENDS product

Product usage order A B N C E D; Product usage order B C A D N E; Product usage order C D B E A N; Product usage order D E C N B A; Product usage order E N D A C B; Product usage order N A E B D C

Product C OTHER

Flavor variant P1211217 of a 2.4% nicotine ENDS product

Product usage order A B N C E D; Product usage order B C A D N E; Product usage order C D B E A N; Product usage order D E C N B A; Product usage order E N D A C B; Product usage order N A E B D C

Product D OTHER

Flavor variant P1211222 of a 5.0% nicotine ENDS product

Product usage order A B N C E D; Product usage order B C A D N E; Product usage order C D B E A N; Product usage order D E C N B A; Product usage order E N D A C B; Product usage order N A E B D C

Product E OTHER

Flavor variant P1213616 of a 1.5% nicotine ENDS product

Product usage order A B N C E D; Product usage order B C A D N E; Product usage order C D B E A N; Product usage order D E C N B A; Product usage order E N D A C B; Product usage order N A E B D C

Product N OTHER

Nicorette® White Ice Mint 4 mg nicotine gum

Product usage order A B N C E D; Product usage order B C A D N E; Product usage order C D B E A N; Product usage order D E C N B A; Product usage order E N D A C B; Product usage order N A E B D C

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 male or female, 21 to 60 years of age, inclusive, at the time of consent.
• Expired breath carbon monoxide level is ≥ 10 ppm and ≤ 100 ppm at Screening.
• Positive urine cotinine test at Screening.
• Smokes only combustible, filtered, menthol cigarettes, 83 mm to 100 mm in length.
• Agrees to smoke same usual brand (UB) cigarette throughout the study period. UB cigarette is defined as the cigarette brand style currently smoked most frequently by the subject.
• Subjects must meet one (a or b) of the following tobacco use conditions:
• Smokes at least 10 cigarettes per day (on average) 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 Principal Investigator (PI).
• Dual user of combustible cigarettes and electronic cigarettes (ECs) who self-reports:
• i. Smoking at least 10 cigarettes per day (on average) and inhales the smoke, for at least 6 months prior to Screening Visit. Brief periods of abstinence more than 30 days prior to screening due to illness, quit attempt or clinical study participation will be allowed at the discretion of the Investigator and ii. Using a nicotine-containing ENDS (cartridge or a tank system).
• 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, ENDS, and Nicorette gum during the study period.
• Willing to abstain from tobacco and nicotine use for at least 12 hours prior to each Test Session.
• Females must be willing to use a form of contraception acceptable to the PI from the time of signing informed consent until End-of-Study.
• Agrees to in-clinic confinement of 8 days and 7 nights.

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.
• 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 for females or \<13.0 for males g/dL at Screening.
• 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.
• Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
• 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.
• Must not be a current regular user (i.e., \> 5 times per month) of any tobacco products other than CCs or ENDS within the last 6 months prior to screening.
• 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 the signing of informed consent.
• History or presence of bleeding or clotting disorders.
• Any use of anticoagulants or daily use of aspirin (≥ 325 mg).
• Whole blood donation within 8 weeks (≤ 56 days) prior to the signing of informed consent and between Screening and check-in Day 1.
• Plasma donation within (≤) 7 days prior to the signing of informed consent and between Screening and check-in Day 1.
• Participation in another clinical trial within (≤) 30 days prior to the signing of informed consent. The 30-day window for each subject will be derived from the date of the last study event in the previous study to the time of signing the ICF in the current study.

Sponsors & Collaborators

• RAI Services Company: lead

Study Sites (2)

QPS Bio-Kinetic

Springfield, Missouri, 65802, United States

Location

AMR Knoxville

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Conditions

Smoking; Tobacco Use; Tobacco Smoking

Interventions

HTR3D protein, human

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Jason Hong, MD

  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: January 13, 2022
• First Posted: January 27, 2022
• Study Start: March 21, 2022
• Primary Completion: May 17, 2022
• Study Completion: May 17, 2022
• Last Updated: June 29, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)