SmokingNCT04094363
CSD190202: Study to Assess Elements of Abuse Liability for Two Electronic Nicotine Delivery Systems
A study testing Product A, Product B and Product C in people with Smoking and Tobacco Smoking, run by RAI Services Company at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Tobacco Smoking, Tobacco Use
- What is being tested?
- Product A, Product B and Product C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Oct 2019to 26 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the course of the study.
- Individuals ≥ 35 years of age currently using systemic, estrogen-containing contraception or hormone replacement therapy.
- A positive urine drug screen without evidence of prescribed corresponding concomitant medication(s) at Screening or Day 1.
- Postpones a decision to quit using tobacco- or nicotine-containing products in order to participate in this study or a previous attempt within (≤) 30 days prior to the signing of the ICF.
- Drinks more than 21 servings of alcoholic beverages per week or has a positive alcohol breathalyzer result at Screening or Day 1.
- Employed by a tobacco or nicotine company, the study site, or handles tobacco- or nicotine-containing products as part of their job.
- Determined by the PI to be inappropriate for this study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
New Orleans Center for Clinical Research (NOCCR)
Knoxville, Tennessee, 37920
ICON Clinical Research
San Antonio, Texas, 78209
About this study
Official title: CSD190202: A Randomized, Open-Label, Crossover Study to Assess Elements of Abuse Liability for Two Electronic Nicotine Delivery Systems
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.
Read the detailed description
The study will recruit smokers of combustible cigarettes.
Potential subjects will complete a pre-screening interview and a Screening Visit to assess their eligibility within 45 days prior to enrollment.
Starting on Day 1, eligible smokers will be confined at the clinical site for 9 days. Subjects will participate in four separate Test Sessions for AL assessment, one for each IP. Each Test Session will last for approximately 4 hours during and following IP use. Subjects will be randomized to use one IP in each Test Session: Usual Brand (UB) combustible cigarettes, nicotine gum, and 2 Electronic Nicotine Delivery Systems (ENDS).
For approximately a day and a half prior to each respective Test Session, IP will be dispensed for ad libitum use for product familiarization.
- Conditions
- Smoking, Tobacco Smoking, Tobacco Use
- Being tested
- Product A, Product B, Product C, Product D
- Medical subject headings
- Smoking, Tobacco Smoking, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Product AOther
Usual Brand, filtered combustible cigarette
Product BOther
CSD1902-11, an electronic nicotine delivery system
Product COther
CSD1902-21, an electronic nicotine delivery system
Product DOther
4mg Nicotine gum
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start3 Oct 2019
- Primary completion26 Nov 2019
- Study completion26 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by RAI Services CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAI Services Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Responsible party
- Sponsor
- Investigators
- Jason Hong, MD, Study director, RAIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094363
- Sponsor's protocol ID
- CSD190202
- Status last verified
- Jun 2022
- First submitted
- 16 Sep 2019
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSD190202: A Randomized, Open-Label, Crossover Study to Assess Elements of Abuse Liability for Two Electronic Nicotine Delivery Systems
- ClinicalTrials.gov ID
- NCT04094363
- Acronym / sponsor ID
- CSD190202
- Conditions
- Smoking, Tobacco Smoking, Tobacco Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- RAI Services CompanyIndustry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Study start
- 3 Oct 2019 (actual)
- Primary completion
- 26 Nov 2019 (actual)
- Study completion
- 26 Nov 2019 (actual)
- First posted
- 18 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will recruit smokers of combustible cigarettes.
Potential subjects will complete a pre-screening interview and a Screening Visit to assess their eligibility within 45 days prior to enrollment.
Starting on Day 1, eligible smokers will be confined at the clinical site for 9 days. Subjects will participate in four separate Test Sessions for AL assessment, one for each IP. Each Test Session will last for approximately 4 hours during and following IP use. Subjects will be randomized to use one IP in each Test Session: Usual Brand (UB) combustible cigarettes, nicotine gum, and 2 Electronic Nicotine Delivery Systems (ENDS).
For approximately a day and a half prior to each respective Test Session, IP will be dispensed for ad libitum use for product familiarization.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Product usage order ABCD | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product DSubjects 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. |
| Product usage order BDAC | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product DSubjects 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. |
| Product usage order CADB | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product DSubjects 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. |
| Product usage order DCBA | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product DSubjects 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. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Product AUsual Brand, filtered combustible cigarette | Other | Product usage order ABCD, Product usage order BDAC, Product usage order CADB, Product usage order DCBA |
| Product BCSD1902-11, an electronic nicotine delivery system | Other | Product usage order ABCD, Product usage order BDAC, Product usage order CADB, Product usage order DCBA |
| Product CCSD1902-21, an electronic nicotine delivery system | Other | Product usage order ABCD, Product usage order BDAC, Product usage order CADB, Product usage order DCBA |
| Product D4mg Nicotine gum | Other | Product usage order ABCD, Product usage order BDAC, Product usage order CADB, Product usage order DCBA |
Primary outcome
AUECPL 10-240
Time frame: 3, 5, 10, 15, 30, 45, 60, 90, 180, and 240 minutes
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.
Emax PL
Time frame: 3, 5, 10, 15, 30, 45, 60, 90, 180, and 240 minutes
Maximum response for product effects with regards to PL score after the start of IP use.
Eoverall IUA
Time frame: 240 minutes
Overall intent to use again (IUA), measured at 240 minutes after the start of IP use.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Hong, MD study director
RAIS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Product A, Product B and Product C in people with Smoking and Tobacco Smoking, run by RAI Services Company at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUECPL 10-240 (time frame: 3, 5, 10, 15, 30, 45, 60, 90, 180, and 240 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2022; AzTrials last refreshed its copy on 1 Nov 2026.