CSD190401: A Study to Assess Elements of Abuse Liability for Nicotine-containing Pouch Tobacco Products
CSD190401: An In-Clinic Confinement Study to Assess Elements of Abuse Liability for Nicotine-containing Pouch Tobacco Products
1 other identifier
interventional
42
1 country
1
Brief Summary
This is a single site, open-label, randomized, 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 subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2020
CompletedFirst Posted
Study publicly available on registry
May 4, 2020
CompletedStudy Start
First participant enrolled
May 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 4, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 4, 2020
CompletedSeptember 25, 2020
September 1, 2020
29 days
April 29, 2020
September 24, 2020
Conditions
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 (10)
Product usage order ABECD
EXPERIMENTALSubjects will use each of the 5 products sequentially (ABECD) during an evaluation period, followed by a 6 hour Test Session.
Product usage order BCADE
EXPERIMENTALSubjects will use each of the 5 products sequentially (BCADE) during an evaluation period, followed by a 6 hour Test Session.
Product usage order CDBEA
EXPERIMENTALSubjects will use each of the 5 products sequentially (CDBEA) during an evaluation period, followed by a 6 hour Test Session.
Product usage order DECAB
EXPERIMENTALSubjects will use each of the 5 products sequentially (DECAB) during an evaluation period, followed by a 6 hour Test Session.
Product usage order EADBC
EXPERIMENTALSubjects will use each of the 5 products sequentially (EADBC) during an evaluation period, followed by a 6 hour Test Session.
Product usage order DCEBA
EXPERIMENTALSubjects will use each of the 5 products sequentially (DCEBA) during an evaluation period, followed by a 6 hour Test Session.
Product usage order EDACB
EXPERIMENTALSubjects will use each of the 5 products sequentially (EDACB) during an evaluation period, followed by a 6 hour Test Session.
Product usage order AEBDC
EXPERIMENTALSubjects will use each of the 5 products sequentially (AEBDC) during an evaluation period, followed by a 6 hour Test Session.
Product usage order BACED
EXPERIMENTALSubjects will use each of the 5 products sequentially (BACED) during an evaluation period, followed by a 6 hour Test Session.
Product usage order CBDAE
EXPERIMENTALSubjects will use each of the 5 products sequentially (CBDAE) during an evaluation period, followed by a 6 hour Test Session.
Interventions
Usual brand (UB) filtered, combustible cigarette
Nicorette® White Ice Mint 2 mg nicotine gum
CSD1904-01, a nicotine pouch, 2 mg nicotine
CSD1904-02, a nicotine pouch, 4 mg nicotine
CSD1904-02, a nicotine pouch, 8 mg nicotine (simultaneous use of two 4 mg nicotine pouches)
Eligibility Criteria
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 pouch products, 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 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 a vapor product (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.
- 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 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 informed consent form (ICF) in the current study.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New Orleans Center for Clinical Research (NOCCR)
Knoxville, Tennessee, 37920, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bobbette Jones, DrPH
RAIS
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
April 29, 2020
First Posted
May 4, 2020
Study Start
May 6, 2020
Primary Completion
June 4, 2020
Study Completion
June 4, 2020
Last Updated
September 25, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share