CSD190202: Study to Assess Elements of Abuse Liability for Two Electronic Nicotine Delivery Systems

NCT04094363 | Completed

• 1 other identifier: CSD190202
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

This is a randomized, open-label, crossover 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 investigational products (IPs) by healthy subjects.

Conditions

Smoking; Tobacco Smoking; Tobacco Use

Outcome Measures

Primary Outcomes (3)

• AUECPL 10-240

  Area under the product liking (PL) NRS score-versus-time curve from 10 minutes to 240 minutes after the start of investigational product (IP) use.

  3, 5, 10, 15, 30, 45, 60, 90, 180, and 240 minutes

• Emax PL

  Maximum response for product effects with regards to PL score after the start of IP use.

  3, 5, 10, 15, 30, 45, 60, 90, 180, and 240 minutes

• Eoverall IUA

  Overall intent to use again (IUA), measured at 240 minutes after the start of IP use.

  240 minutes

Study Arms (4)

Product usage order ABCD

EXPERIMENTAL

Subjects will use each of the 4 products (ABCD) sequentially for 1 and 1/2 days during a 9 day confinement, followed by a 4 hour Test Session.

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

Product usage order BDAC

EXPERIMENTAL

Subjects will use each of the 4 products (BDAC) sequentially for 1 and 1/2 days during a 9 day confinement, followed by a 4 hour Test Session.

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

Product usage order CADB

EXPERIMENTAL

Subjects will use each of the 4 products (CADB) sequentially for 1 and 1/2 days during a 9 day confinement, followed by a 4 hour Test Session.

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

Product usage order DCBA

EXPERIMENTAL

Subjects will use each of the 4 products (DCBA) sequentially for 1 and 1/2 days during a 9 day confinement, followed by a 4 hour Test Session.

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

Interventions

Product A OTHER

Usual Brand, filtered combustible cigarette

Product usage order ABCD; Product usage order BDAC; Product usage order CADB; Product usage order DCBA

Product B OTHER

CSD1902-11, an electronic nicotine delivery system

Product usage order ABCD; Product usage order BDAC; Product usage order CADB; Product usage order DCBA

Product C OTHER

CSD1902-21, an electronic nicotine delivery system

Product usage order ABCD; Product usage order BDAC; Product usage order CADB; Product usage order DCBA

Product D OTHER

4mg Nicotine gum

Product usage order ABCD; Product usage order BDAC; Product usage order CADB; Product usage order DCBA

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, non-menthol, 83 mm to 100 mm in length.
• Agrees to smoke same UB combustible cigarette throughout the study period. UB combustible cigarette is defined as the 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. 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).
• 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 combustible 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 9 days and 8 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.
• 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.
• Use of an ENDS or other tobacco or nicotine-containing product (e.g., lozenges, moist snuff) within (≤) 30 days prior to Screening.
• Use of any medication or substance that aids in smoking cessation, including but not limited to any Nicotine Replacement Therapy (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.
• 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
• ICON plc: collaborator

Study Sites (2)

New Orleans Center for Clinical Research (NOCCR)

Knoxville, Tennessee, 37920, United States

Location

ICON Clinical Research

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Conditions

Smoking; Tobacco Smoking; Tobacco Use

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: September 16, 2019
• First Posted: September 18, 2019
• Study Start: October 3, 2019
• Primary Completion: November 26, 2019
• Study Completion: November 26, 2019
• Last Updated: June 27, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)