CSD170401: Study to Assess Elements of Abuse Liability for Three Electronic Tobacco Vapor Products During an 11-Day In-Clinic Confinement
CSD170401: A Single-Center, Randomized, Open-Label, Crossover Study to Assess Elements of Abuse Liability for Three Electronic Tobacco Vapor Products During an 11-Day In-Clinic Confinement
1 other identifier
interventional
40
1 country
1
Brief Summary
This study will examine elements of abuse liability (AL) related to potential product adoption of three electronic tobacco vapor products by current smokers relative to high and low AL comparator products (usual brand cigarette and nicotine gum, respectively). Changes in subjective measures, speed and amount of nicotine uptake, and maximum changes in physiological effects during and after product use that follows a 12-hour (minimum) tobacco and nicotine abstinence period, will be determined. The electronic tobacco vapor products will not be compared to each other.
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 Apr 2017
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
Study Start
First participant enrolled
April 17, 2017
CompletedFirst Submitted
Initial submission to the registry
April 19, 2017
CompletedFirst Posted
Study publicly available on registry
April 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 25, 2017
CompletedJune 27, 2017
June 1, 2017
1 month
April 19, 2017
June 23, 2017
Conditions
Outcome Measures
Primary Outcomes (6)
AUECPL 15-240
Area under the product liking (PL) NRS score-versus-time curve from 15 minutes to 240 minutes after the start of investigational product (IP) use.
-5, 5, 15, 30, 45, 60, 90, 120, 150, 180, and 240 Minutes
Emax PL
Maximum response for product effects with regards to PL score after the start of IP use.
-5, 5, 15, 30, 45, 60, 90, 120, 150, 180, and 240 Minutes
Eoverall IUA
Overall intent to use again (IUA), measured at 240 minutes after the start of IP use.
240 Minutes
AUCnic 0-240
Baseline-adjusted area under the nicotine concentration-versus-time curve from time zero to 240 minutes after the start of IP use.
-5, -0.5, 5, 7.5, 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, and 240 Minutes.
Cmax
Maximum baseline-adjusted plasma concentration.
-5, -0.5, 5, 7.5, 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, and 240 Minutes.
Tmax
Time to maximum baseline-adjusted plasma concentration.
-5, -0.5, 5, 7.5, 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, and 240 Minutes.
Study Arms (10)
Product usage order ABECD
EXPERIMENTALSubjects will use each of the 5 products (ABECD) sequentially for 1 and 1/2 days during an 11 day confinement, followed by a 4 hour Test Session.
Product usage order BCADE
EXPERIMENTALSubjects will use each of the 5 products (BCADE) sequentially for 1 and 1/2 days during an 11 day confinement, followed by a 4 hour Test Session.
Product usage order CDBEA
EXPERIMENTALSubjects will use each of the 5 products (CDBEA) sequentially for 1 and 1/2 days during an 11 day confinement, followed by a 4 hour Test Session.
Product usage order DECAB
EXPERIMENTALSubjects will use each of the 5 products (DECAB) sequentially for 1 and 1/2 days during an 11 day confinement, followed by a 4 hour Test Session.
Product usage order EADBC
EXPERIMENTALSubjects will use each of the 5 products (EADBC) sequentially for 1 and 1/2 days during an 11 day confinement, followed by a 4 hour Test Session.
Product usage order DCEBA
EXPERIMENTALSubjects will use each of the 5 products (DCEBA) sequentially for 1 and 1/2 days during an 11 day confinement, followed by a 4 hour Test Session.
Product usage order EDACB
EXPERIMENTALSubjects will use each of the 5 products (EDACB) sequentially for 1 and 1/2 days during an 11 day confinement, followed by a 4 hour Test Session.
Product usage order AEBDC
EXPERIMENTALSubjects will use each of the 5 products (AEBDC) sequentially for 1 and 1/2 days during an 11 day confinement, followed by a 4 hour Test Session.
Product usage order BACED
EXPERIMENTALSubjects will use each of the 5 products (BACED) sequentially for 1 and 1/2 days during an 11 day confinement, followed by a 4 hour Test Session.
Product usage order CBDAE
EXPERIMENTALSubjects will use each of the 5 products (CBDAE) sequentially for 1 and 1/2 days during an 11 day confinement, followed by a 4 hour Test Session.
Interventions
Usual Brand Cigarette
FT21039 an electronic tobacco vapor product
FT21092 an electronic tobacco vapor product
FT21018 an electronic tobacco vapor product
4mg nicotine gum
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.
- Able to safely perform the required study procedures, as determined by the Investigator.
- Expired breath carbon monoxide level is ≥ 15 ppm and ≤ 100 ppm at Screening and Day 1.
- Smokes only combustible, filtered, non-menthol cigarettes, 83 mm to 100 mm in length.
- Agrees to smoke same usual brand (UB) cigarette throughout the study period. Usual brand 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 Investigator.
- Response at Screening to Fagerström Test for Cigarette Dependence (FTCD) 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, electronic tobacco vapor 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 of childbearing potential must be willing to use a form of contraception acceptable to the Investigator from the time of signing informed consent until study discharge. Examples of acceptable forms of contraception include, but are not limited to, the following.
- Surgeries:
- Hysterectomy at least 6 months prior to randomization
- Oophorectomy at least 6 months prior to randomization
- Tubal ligation at least 6 months prior to randomization
- +8 more criteria
You may not qualify if:
- Presence of clinically significant or unstable/uncontrolled acute or chronic medical conditions at Screening or Day 1, as determined by the Investigator, that would preclude the subject from participating safely in the study (e.g., uncontrolled hypertension, lung disease, cardiac disease, neurological disease or psychiatric disorders) based on safety assessments such as clinical laboratory tests, medical history, and physical/oral examinations.
- History, presence of, or clinical laboratory test results indicating diabetes.
- History or presence of stomach ulcers.
- At risk for heart disease that would preclude the subject from participating safely in the study, as determined by the Investigator.
- Use of medicine for the treatment of depression, unless on a stable dose for the past 6 months prior to screening and deemed clinically stable by the PI.
- Current scheduled treatment for asthma within the past consecutive 12 months prior to screening. As needed treatment, such as inhalers, may be included at the PIs discretion pending approval from the medical monitor.
- 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 diastolic blood pressure of \> 95 mmHg at Screening, measured after being seated for at least 5 minutes.
- Hemoglobin level is \< 12 g/dL at Screening.
- Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- History or presence of hemophilia or any other bleeding disorders.
- History or presence of clotting disorders and/or use of anticoagulants (e.g., clopidogrel \[Plavix®\], warfarin \[Coumadin®, Jantoven®\] and aspirin \[\> 325 mg/day\], see Section 7.4 "Concomitant Medications").
- Whole blood donation within 8 weeks (≤ 56 days) prior to Screening.
- Plasma donation within (≤) 7 days prior to Screening.
- Body mass index \< 18.5 or \> 40.0 kg/m2 at Screening.
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RAI Services Companylead
- Celerioncollaborator
Study Sites (1)
Celerion, Inc.
Lincoln, Nebraska, 68502, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles Tomek, MD
Celerion
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 19, 2017
First Posted
April 24, 2017
Study Start
April 17, 2017
Primary Completion
May 25, 2017
Study Completion
May 25, 2017
Last Updated
June 27, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share