SmokingNCT04372290
CSD190401: A Study to Assess Elements of Abuse Liability for Nicotine-containing Pouch Tobacco Products
A study testing Product A, Product B and Product C in people with Smoking and Smoking Behaviors, run by RAI Services Company at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Smoking Behaviors, 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
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2020to 4 Jun 2020
- 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 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.
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- 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).
Who cannot join
- 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.
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- 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.
- 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 signing the ICF.
- Drinks more than 21 servings of alcoholic beverages per week or has a positive alcohol screen 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
1 site in 1 country.
United States1 site
New Orleans Center for Clinical Research (NOCCR)
Knoxville, Tennessee, 37920
About this study
Official title: CSD190401: An In-Clinic Confinement Study to Assess Elements of Abuse Liability for Nicotine-containing Pouch Tobacco Products
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.
Read the detailed description
Cigarette smokers (SMK) and smokers who also use smokeless tobacco (SST) [e.g., snus, moist snuff] will be recruited into the study. An attempt will be made to have approximately one third of the study population made up of SST.
Potential subjects may complete a pre-Screening telephone interview and will complete a Screening Visit to assess their eligibility within 45 days prior to check-in and enrollment/randomization.
Starting on Day -1, eligible subjects will begin confinement at the clinical site for 6 days. Subjects will be randomized to evaluate one investigational product (IP) in each of five separate Test Sessions, such that each subject will evaluate five IPs, including three strengths of the nicotine pouches, and both a high- and a low-AL comparator.
Each Test Session will last for approximately 4 hours during and following IP use and will include collection of both PD measures (subjective and physiological) and PK measures.
On Day -1, subjects will participate in an IP acclimation period where they will be instructed on how to use the nicotine pouch IP and the nicotine gum (low-AL comparator IP). At the end of the acclimation period, subjects will have access to their usual brand (UB) cigarettes for ad libitum use until the 12-hour tobacco abstinence begins prior to the Day 1 Test Session.
- Conditions
- Smoking, Smoking Behaviors, Tobacco Use, Tobacco Smoking
- Being tested
- Product A, Product B, Product C, Product D, Product E
- Medical subject headings
- Smoking, Tobacco Use, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Product AOther
Usual brand (UB) filtered, combustible cigarette
Product BOther
Nicorette® White Ice Mint 2 mg nicotine gum
Product COther
CSD1904-01, a nicotine pouch, 2 mg nicotine
Product DOther
CSD1904-02, a nicotine pouch, 4 mg nicotine
Product EOther
CSD1904-02, a nicotine pouch, 8 mg nicotine (simultaneous use of two 4 mg nicotine pouches)
| Study group | Role | What they receive |
|---|---|---|
| Product usage order ABECD | Experimental | Subjects will use each of the 5 products sequentially (ABECD) during an evaluation period, followed by a 6 hour Test Session. Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E |
| Product usage order BCADE | Experimental | Subjects will use each of the 5 products sequentially (BCADE) during an evaluation period, followed by a 6 hour Test Session. Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E |
| Product usage order CDBEA | Experimental | Subjects will use each of the 5 products sequentially (CDBEA) during an evaluation period, followed by a 6 hour Test Session. Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E |
| Product usage order DECAB | Experimental | Subjects will use each of the 5 products sequentially (DECAB) during an evaluation period, followed by a 6 hour Test Session. Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E |
| Product usage order EADBC | Experimental | Subjects will use each of the 5 products sequentially (EADBC) during an evaluation period, followed by a 6 hour Test Session. Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E |
| Product usage order DCEBA | Experimental | Subjects will use each of the 5 products sequentially (DCEBA) during an evaluation period, followed by a 6 hour Test Session. Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E |
| Product usage order EDACB | Experimental | Subjects will use each of the 5 products sequentially (EDACB) during an evaluation period, followed by a 6 hour Test Session. Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E |
| Product usage order AEBDC | Experimental | Subjects will use each of the 5 products sequentially (AEBDC) during an evaluation period, followed by a 6 hour Test Session. Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E |
| Product usage order BACED | Experimental | Subjects will use each of the 5 products sequentially (BACED) during an evaluation period, followed by a 6 hour Test Session. Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E |
| Product usage order CBDAE | Experimental | Subjects will use each of the 5 products sequentially (CBDAE) during an evaluation period, followed by a 6 hour Test Session. Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 minutes to 240 minutes
Emax PL
maximum product liking (PL) numeric rating scale (NRS) score 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 posted4 May 2020
- Study start6 May 2020
- Primary completion4 Jun 2020
- Study completion4 Jun 2020
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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAI Services Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bobbette Jones, DrPH, Study director, RAIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372290
- Sponsor's protocol ID
- CSD190401
- Status last verified
- Sep 2020
- First submitted
- 29 Apr 2020
- Last updated
- 25 Sep 2020
- 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 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSD190401: An In-Clinic Confinement Study to Assess Elements of Abuse Liability for Nicotine-containing Pouch Tobacco Products
- ClinicalTrials.gov ID
- NCT04372290
- Acronym / sponsor ID
- CSD190401
- Conditions
- Smoking, Smoking Behaviors, Tobacco Use, Tobacco Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- RAI Services CompanyIndustry (pharma, biotech, devices)
- Study start
- 6 May 2020 (actual)
- Primary completion
- 4 Jun 2020 (actual)
- Study completion
- 4 Jun 2020 (actual)
- First posted
- 4 May 2020 (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 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.
Detailed description
Cigarette smokers (SMK) and smokers who also use smokeless tobacco (SST) [e.g., snus, moist snuff] will be recruited into the study. An attempt will be made to have approximately one third of the study population made up of SST.
Potential subjects may complete a pre-Screening telephone interview and will complete a Screening Visit to assess their eligibility within 45 days prior to check-in and enrollment/randomization.
Starting on Day -1, eligible subjects will begin confinement at the clinical site for 6 days. Subjects will be randomized to evaluate one investigational product (IP) in each of five separate Test Sessions, such that each subject will evaluate five IPs, including three strengths of the nicotine pouches, and both a high- and a low-AL comparator.
Each Test Session will last for approximately 4 hours during and following IP use and will include collection of both PD measures (subjective and physiological) and PK measures.
On Day -1, subjects will participate in an IP acclimation period where they will be instructed on how to use the nicotine pouch IP and the nicotine gum (low-AL comparator IP). At the end of the acclimation period, subjects will have access to their usual brand (UB) cigarettes for ad libitum use until the 12-hour tobacco abstinence begins prior to the Day 1 Test Session.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Product usage order ABECD | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product ESubjects will use each of the 5 products sequentially (ABECD) during an evaluation period, followed by a 6 hour Test Session. |
| Product usage order BCADE | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product ESubjects will use each of the 5 products sequentially (BCADE) during an evaluation period, followed by a 6 hour Test Session. |
| Product usage order CDBEA | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product ESubjects will use each of the 5 products sequentially (CDBEA) during an evaluation period, followed by a 6 hour Test Session. |
| Product usage order DECAB | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product ESubjects will use each of the 5 products sequentially (DECAB) during an evaluation period, followed by a 6 hour Test Session. |
| Product usage order EADBC | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product ESubjects will use each of the 5 products sequentially (EADBC) during an evaluation period, followed by a 6 hour Test Session. |
| Product usage order DCEBA | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product ESubjects will use each of the 5 products sequentially (DCEBA) during an evaluation period, followed by a 6 hour Test Session. |
| Product usage order EDACB | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product ESubjects will use each of the 5 products sequentially (EDACB) during an evaluation period, followed by a 6 hour Test Session. |
| Product usage order AEBDC | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product ESubjects will use each of the 5 products sequentially (AEBDC) during an evaluation period, followed by a 6 hour Test Session. |
| Product usage order BACED | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product ESubjects will use each of the 5 products sequentially (BACED) during an evaluation period, followed by a 6 hour Test Session. |
| Product usage order CBDAE | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product ESubjects will use each of the 5 products sequentially (CBDAE) during an evaluation period, followed by a 6 hour Test Session. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 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 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.
Key exclusion criteria (22 listed)
- 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.
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 (UB) filtered, combustible cigarette | Other | Product usage order ABECD, Product usage order AEBDC, Product usage order BACED, Product usage order BCADE, Product usage order CBDAE, Product usage order CDBEA, Product usage order DCEBA, Product usage order DECAB, Product usage order EADBC, Product usage order EDACB |
| Product BNicorette® White Ice Mint 2 mg nicotine gum | Other | Product usage order ABECD, Product usage order AEBDC, Product usage order BACED, Product usage order BCADE, Product usage order CBDAE, Product usage order CDBEA, Product usage order DCEBA, Product usage order DECAB, Product usage order EADBC, Product usage order EDACB |
| Product CCSD1904-01, a nicotine pouch, 2 mg nicotine | Other | Product usage order ABECD, Product usage order AEBDC, Product usage order BACED, Product usage order BCADE, Product usage order CBDAE, Product usage order CDBEA, Product usage order DCEBA, Product usage order DECAB, Product usage order EADBC, Product usage order EDACB |
| Product DCSD1904-02, a nicotine pouch, 4 mg nicotine | Other | Product usage order ABECD, Product usage order AEBDC, Product usage order BACED, Product usage order BCADE, Product usage order CBDAE, Product usage order CDBEA, Product usage order DCEBA, Product usage order DECAB, Product usage order EADBC, Product usage order EDACB |
| Product ECSD1904-02, a nicotine pouch, 8 mg nicotine (simultaneous use of two 4 mg nicotine pouches) | Other | Product usage order ABECD, Product usage order AEBDC, Product usage order BACED, Product usage order BCADE, Product usage order CBDAE, Product usage order CDBEA, Product usage order DCEBA, Product usage order DECAB, Product usage order EADBC, Product usage order EDACB |
Primary outcome
AUECPL 5-240
Time frame: 5 minutes to 240 minutes
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.
Emax PL
Time frame: 240 minutes
maximum product liking (PL) numeric rating scale (NRS) score 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 25 Sep 2020.
- 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.
Bobbette Jones, DrPH study director
RAIS
1 site 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 Smoking Behaviors, run by RAI Services Company at 1 site 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 13 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 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 5-240 (time frame: 5 minutes to 240 minutes). The study lists 2 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 25 Sep 2020.