CSD190301: A Study to Assess Elements of Abuse Liability for Two Dissolvable Nicotine Lozenge Tobacco Products

NCT04167384 | Completed

• 1 other identifier: CSD190301
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

This is a two-arm, single use, single-center, randomized, 10-sequence per arm, open-label, crossover pharmacokinetic/pharmacodynamic (PK/PD) study, designed to evaluate elements of abuse liability (AL) including subjective effects, plasma nicotine uptake, and physiological measures during and following ad libitum use of the study investigational products (IPs) by generally healthy subjects.

Conditions

Smoking; Tobacco Use; Tobacco Smoking

Outcome Measures

Primary Outcomes (2)

• AUEC PL 5-360

  area under the effects curve (AUEC) for product liking (PL) Visual Analogue Scale (VAS) score-versus-time curve from 5 minutes to 360 minutes after the start of IP use. Data is collected from a 100 point VAS scale; Range from 0 = "Strongly dislike" to 100 = "Strongly Like"

  5, 7.5, 10, 15, 20, 30, 45, 60, 120, 180, 240, and 360 minutes

• Emax PL

  maximum product liking Visual Analogue Scale (VAS) score after the start of IP use. Data is collected from a 100 point VAS scale; Range from 0 = "Strongly dislike" to 100 = "Strongly Like"

  360 Minutes

Study Arms (2)

Hard nicotine lozenge arm

EXPERIMENTAL

Subjects will use each of the 5 products sequentially during an evaluation period, followed by a 6 hour Test Session.

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

Soft nicotine lozenge arm

EXPERIMENTAL

Subjects will use each of the 5 products sequentially during an evaluation period, followed by a 6 hour Test Session.

Other: Product A; Other: Product B; Other: Product F; Other: Product G; Other: Product H

Interventions

Product A OTHER

Usual brand (UB) filtered, combustible cigarette

Hard nicotine lozenge arm; Soft nicotine lozenge arm

Product B OTHER

Nicorette® Mint 4 mg nicotine lozenge

Hard nicotine lozenge arm; Soft nicotine lozenge arm

Product C OTHER

CSD1903-11, a hard nicotine lozenge, 2 mg nicotine

Hard nicotine lozenge arm

Product D OTHER

CSD1903-11, a hard nicotine lozenge, 4 mg nicotine

Hard nicotine lozenge arm

Product E OTHER

CSD1903-11, a hard nicotine lozenge, 8 mg nicotine

Hard nicotine lozenge arm

Product F OTHER

CSD1903-12, a soft nicotine lozenge, 2 mg nicotine

Soft nicotine lozenge arm

Product G OTHER

CSD1903-12, a soft nicotine lozenge, 4 mg nicotine

Soft nicotine lozenge arm

Product H OTHER

CSD1903-12, a soft nicotine lozenge, 8 mg nicotine

Soft nicotine lozenge arm

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 combustible, filtered, non-menthol or menthol cigarettes, 83 mm to 100 mm in length as primary source of tobacco. Other cigarette sizes may be allowed with sponsor approval.
• Smokers who also use smokeless tobacco products may be enrolled.
• Agrees to smoke same UB cigarette throughout the study period. UB cigarette is defined as the reported cigarette brand style currently smoked most frequently by the subject.
• Smokes at least 10 cigarettes per day (on average) and inhales the smoke, for at least 6 months prior to Screening.
• Response at Screening to 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, nicotine lozenges, and Nicorette® lozenge 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 Principal Investigator (PI) from the time of signing informed consent until End-of-Study.
• Agrees to in-clinic confinement of 6 days (5 nights).

You may not qualify if:

• Uses vapor products (e.g., e-cigarettes, tank systems) more than one day per week, for the past 6 months prior to screening.
• 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.
• Known history of sensitivity to aspartame / phenylalanine
• 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 Day -1.
• Weight of ≤ 110 pounds.
• Hemoglobin level is \< 12.5 g/dL for females or \<13.0 g/dL for males 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.
• Use of any medication or substance that aids in smoking cessation, including but not limited to any NRT (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 aspirin (≥ 325 mg/day).
• Whole blood donation within 8 weeks (≤ 56 days) prior to the signing of informed consent.
• Plasma donation within (≤) 7 days prior to the signing of informed consent.

Sponsors & Collaborators

• RAI Services Company: lead

Study Sites (1)

High Point Clinical Trials Center

High Point, North Carolina, 27265, United States

Location

MeSH Terms

Conditions

Smoking; Tobacco Use; Tobacco Smoking

Interventions

HTR3D protein, human

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Christine Campbell

  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: November 14, 2019
• First Posted: November 18, 2019
• Study Start: December 2, 2019
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: March 12, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)