SmokingNCT04167384
CSD190301: A Study to Assess Elements of Abuse Liability for Two Dissolvable Nicotine Lozenge Tobacco Products
A study testing Product A, Product B and Product C in people with Smoking and Tobacco Use, run by RAI Services Company at 1 site in United States.
Trial summary
This is a two-arm, single use, single-center, randomized, 10-sequence per arm, open-label, crossover pharmacokinetic/pharmacodynamic (PK/PD) study, designed to evaluate elements of abuse liability (AL) including subjective effects, plasma nicotine uptake, and physiological measures during and following ad libitum use… 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 Use, Tobacco Smoking
- 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
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2019to 28 Feb 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 lozenges, and Nicorette® lozenge 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 vapor products (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.
- Known history of sensitivity to aspartame / phenylalanine
- 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.
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- 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 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 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
1 site in 1 country.
United States1 site
High Point Clinical Trials Center
High Point, North Carolina, 27265
About this study
Official title: CSD190301: A Study to Assess Elements of Abuse Liability for Two Dissolvable Nicotine Lozenge Tobacco Products During a 6-Day In-Clinic Confinement
This is a two-arm, single use, single-center, randomized, 10-sequence per arm, open-label, crossover pharmacokinetic/pharmacodynamic (PK/PD) 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 study investigational products (IPs) by generally healthy subjects.
Read the detailed description
Cigarette smokers and smokers who also use smokeless tobacco (SST) [e.g., snus, moist snuff] will be recruited into the study.
Starting on Day -1, eligible subjects will be confined at the clinical site for 6 days. Subjects will be randomized to evaluate one IP in each of five separate Test Sessions, such that each subject will evaluate five IPs: one of two forms of the nicotine lozenge in three different regimens, a commercially-available nicotine replacement therapy (NRT) nicotine lozenge, and the subjects' usual brand (UB) cigarettes.
Each Test Session will last for approximately 6 hours during and following IP use and will include collection of subjective measures, PK assessments and physiological measures.
On Day -1, subjects will be instructed on how to use both the specific lozenge IP in their assigned study arm and the NRT lozenge and will have one trial use of both IP.
- Conditions
- Smoking, 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® Mint 4 mg nicotine lozenge
Product COther
CSD1903-11, a hard nicotine lozenge, 2 mg nicotine
Product DOther
CSD1903-11, a hard nicotine lozenge, 4 mg nicotine
Product EOther
CSD1903-11, a hard nicotine lozenge, 8 mg nicotine
Product FOther
CSD1903-12, a soft nicotine lozenge, 2 mg nicotine
Product GOther
CSD1903-12, a soft nicotine lozenge, 4 mg nicotine
Product HOther
CSD1903-12, a soft nicotine lozenge, 8 mg nicotine
| Study group | Role | What they receive |
|---|---|---|
| Hard nicotine lozenge arm | Experimental | Subjects will use each of the 5 products sequentially 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 |
| Soft nicotine lozenge arm | Experimental | Subjects will use each of the 5 products sequentially during an evaluation period, followed by a 6 hour Test Session. Receives: Other: Product A; Other: Product B; Other: Product F; Other: Product G; Other: Product H |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUEC PL 5-360
area under the effects curve (AUEC) for product liking (PL) Visual Analogue Scale (VAS) score-versus-time curve from 5 minutes to 360 minutes after the start of IP use. Data is collected from a 100 point VAS scale; Range from 0 = "Strongly dislike" to 100 = "Strongly Like"
Measured: 5, 7.5, 10, 15, 20, 30, 45, 60, 120, 180, 240, and 360 minutes
Emax PL
maximum product liking Visual Analogue Scale (VAS) score after the start of IP use. Data is collected from a 100 point VAS scale; Range from 0 = "Strongly dislike" to 100 = "Strongly Like"
Measured: 360 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start2 Dec 2019
- Primary completion28 Feb 2020
- Study completion28 Feb 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
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAI Services Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christine Campbell, Study director, RAIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167384
- Sponsor's protocol ID
- CSD190301
- Status last verified
- Mar 2020
- First submitted
- 14 Nov 2019
- Last updated
- 12 Mar 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 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSD190301: A Study to Assess Elements of Abuse Liability for Two Dissolvable Nicotine Lozenge Tobacco Products During a 6-Day In-Clinic Confinement
- ClinicalTrials.gov ID
- NCT04167384
- Acronym / sponsor ID
- CSD190301
- Conditions
- Smoking, Tobacco Use, Tobacco Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- RAI Services CompanyIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 18 Nov 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 two-arm, single use, single-center, randomized, 10-sequence per arm, open-label, crossover pharmacokinetic/pharmacodynamic (PK/PD) 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 study investigational products (IPs) by generally healthy subjects.
Detailed description
Cigarette smokers and smokers who also use smokeless tobacco (SST) [e.g., snus, moist snuff] will be recruited into the study.
Starting on Day -1, eligible subjects will be confined at the clinical site for 6 days. Subjects will be randomized to evaluate one IP in each of five separate Test Sessions, such that each subject will evaluate five IPs: one of two forms of the nicotine lozenge in three different regimens, a commercially-available nicotine replacement therapy (NRT) nicotine lozenge, and the subjects' usual brand (UB) cigarettes.
Each Test Session will last for approximately 6 hours during and following IP use and will include collection of subjective measures, PK assessments and physiological measures.
On Day -1, subjects will be instructed on how to use both the specific lozenge IP in their assigned study arm and the NRT lozenge and will have one trial use of both IP.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hard nicotine lozenge arm | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product ESubjects will use each of the 5 products sequentially during an evaluation period, followed by a 6 hour Test Session. |
| Soft nicotine lozenge arm | Experimental | Other: Product A, Other: Product B, Other: Product F, Other: Product G, Other: Product HSubjects will use each of the 5 products sequentially 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 (23 listed)
- Uses vapor products (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.
- Known history of sensitivity to aspartame / phenylalanine
- 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.
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 | Hard nicotine lozenge arm, Soft nicotine lozenge arm |
| Product BNicorette® Mint 4 mg nicotine lozenge | Other | Hard nicotine lozenge arm, Soft nicotine lozenge arm |
| Product CCSD1903-11, a hard nicotine lozenge, 2 mg nicotine | Other | Hard nicotine lozenge arm |
| Product DCSD1903-11, a hard nicotine lozenge, 4 mg nicotine | Other | Hard nicotine lozenge arm |
| Product ECSD1903-11, a hard nicotine lozenge, 8 mg nicotine | Other | Hard nicotine lozenge arm |
| Product FCSD1903-12, a soft nicotine lozenge, 2 mg nicotine | Other | Soft nicotine lozenge arm |
| Product GCSD1903-12, a soft nicotine lozenge, 4 mg nicotine | Other | Soft nicotine lozenge arm |
| Product HCSD1903-12, a soft nicotine lozenge, 8 mg nicotine | Other | Soft nicotine lozenge arm |
Primary outcome
AUEC PL 5-360
Time frame: 5, 7.5, 10, 15, 20, 30, 45, 60, 120, 180, 240, and 360 minutes
area under the effects curve (AUEC) for product liking (PL) Visual Analogue Scale (VAS) score-versus-time curve from 5 minutes to 360 minutes after the start of IP use. Data is collected from a 100 point VAS scale; Range from 0 = "Strongly dislike" to 100 = "Strongly Like"
Emax PL
Time frame: 360 Minutes
maximum product liking Visual Analogue Scale (VAS) score after the start of IP use. Data is collected from a 100 point VAS scale; Range from 0 = "Strongly dislike" to 100 = "Strongly Like"
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 12 Mar 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.
Christine Campbell 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 Tobacco Use, 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 23 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 12 Mar 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?
AUEC PL 5-360 (time frame: 5, 7.5, 10, 15, 20, 30, 45, 60, 120, 180, 240, and 360 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 12 Mar 2020.