CSD201301: Study to Assess Elements of Abuse Liability for Four P13 Nicotine Pouches

NCT05294497 | Completed

• 1 other identifier: CSD201301
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

This is a two-site, open-label, randomized, 6-way 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; Tobacco Use; Tobacco Smoking

Outcome Measures

Primary Outcomes (2)

• (AUECPL) 5-240: area-under-the-effects curve (AUEC) for Product Liking (PL)

  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. 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)

  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 6 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 N; Other: Product E

Product usage order B C A D N E

EXPERIMENTAL

Subjects will use each of the 6 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 N; Other: Product E

Product usage order C D B E A N

EXPERIMENTAL

Subjects will use each of the 6 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 N; Other: Product E

Product usage order D E C N B A

EXPERIMENTAL

Subjects will use each of the 6 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 N; Other: Product E

Product usage order E N D A C B

EXPERIMENTAL

Subjects will use each of the 6 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 N; Other: Product E

Product usage order N A E B D C

EXPERIMENTAL

Subjects will use each of the 6 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 N; Other: Product E

Interventions

Product A OTHER

Usual Brand (UB) filtered, non-menthol or menthol 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 P1312914 of a nicotine pouch product with 4 mg of nicotine

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 P1312915 of a nicotine pouch product with 8 mg of nicotine

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 P1313014 of a nicotine pouch product with 4 mg of nicotine

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

Product E OTHER

Flavor variant P1313015 of a nicotine pouch product with 8 mg of nicotine

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 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 as primary source of tobacco.
• 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.
• Smokers who also use ST products (e.g., moist snuff, snus), and have used ST within 30 days prior to screening will be enrolled.
• 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" (Heatherton et al., 1991).
• Willing to use UB cigarette, nicotine pouch IPs, and Nicorette® gum during the study period.
• Willing to abstain from tobacco and nicotine use for at least 12 hours prior to the start of each of six Test Sessions.
• 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.
• Examples of acceptable means of birth control are, but not limited to:
• Surgical sterilization (hysterectomy, bilateral tubal ligation/occlusion, bilateral oophorectomy, bilateral salpingectomy);
• physical barrier method (e.g., condom, diaphragm/sponge/cervical cap) with spermicide;

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 informed consent.
• Postpones a decision to quit using tobacco- or nicotine-containing products in order to participate in this study or self-reports a previous quit attempt within (≤) 30 days prior to signing the informed consent.
• Any use of daily aspirin (≥ 325 mg) or any use of other anticoagulants.
• Individuals ≥ 35 years of age currently using systemic, estrogen-containing contraception or hormone replacement therapy.

Sponsors & Collaborators

• RAI Services Company: lead

Study Sites (2)

AMR Lexington

Lexington, Kentucky, 40509, United States

Location

AMR Knoxville

Knoxville, Tennessee, 37920, United States

Location

Related Publications (1)

• Kanobe MN, Powell CY, Patrudu M, Baxter SA, Tapia MA, Darnell J, Prevette K, Gibson AG, Ayoku SA, Campbell L, Coffield JW, Keyser BM, Ganesh BS, Gale N, Jordan KG. Randomized crossover clinical studies to assess abuse liability and nicotine pharmacokinetics of Velo Oral Nicotine pouches. Front Pharmacol. 2025 Mar 13;16:1547073. doi: 10.3389/fphar.2025.1547073. eCollection 2025.

  PMID: 40183092 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: March 15, 2022
• First Posted: March 24, 2022
• Study Start: May 1, 2022
• Primary Completion: May 27, 2022
• Study Completion: May 27, 2022
• Last Updated: June 29, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)