Tobacco UseNCT03688776
CSD1805: Study to Assess Nicotine Uptake and Product Use Behavior in Moist Snuff Consumers Using Two Moist Snuff Products
A study testing 1805AA and 1805AB in people with Tobacco Use, run by RAI Services Company at 2 sites in United States.
Trial summary
The purpose of this study is to compare nicotine uptake and product use behavior during and following use of two moist snuff products in generally healthy, adult moist snuff users. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use
- What is being tested?
- 1805AA and 1805AB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Oct 2018to 2 Dec 2018
- 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 signing informed consent;
- Positive urine cotinine test at the Screening Visit and Day 1;
- Females must be willing to use a form of contraception acceptable to the Principal Investigator (PI) from the time of signing the ICF until study discharge;
- Subjects' primary tobacco product must be a moist snuff product. Dual use of other forms of tobacco- and/or nicotine-containing products will be allowed but not more frequently than four days per week;
- Self-reports currently using at least one can of their non-pouched usual brand (UB) moist snuff per week for at least 3 months prior to Enrollment;
- Agrees to exclusively use the IP and not use any other tobacco- or nicotine-containing product during the course of the study;
- Able to safely perform the required study procedures, as determined by the PI.
Who cannot join
- Presence of clinically significant or unstable/uncontrolled acute or chronic medical conditions at the time of signing the ICF, as determined by the PI, that would preclude a subject from participating safely in the study (e.g., uncontrolled hypertension, cardiac disease, neurological disease, psychiatric disorders) based on safety assessments such as clinical laboratory tests, pregnancy tests, medical history, and physical/oral examinations;
- History, presence of, or clinical laboratory test results indicating diabetes;
- Systolic blood pressure of > 160 mmHg or a diastolic blood pressure of > 95mmHg, measured after being seated for 5 minutes;
- Hemoglobin level < 12.5 g/dL for females and < 13.0 g/dL for males at the Screening Visit;
- 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;
Show all 19Show fewer
- Use of any medication or substance that aids in smoking cessation, including but not limited to any nicotine replacement therapy (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract within 30 days prior to signing the ICF;
- History or presence of bleeding or clotting disorders;
- Any use of anticoagulants or aspirin (>325mg/day);
- Whole blood donation within 8 weeks (≤ 56 days) prior to the signing the ICF;
- Plasma donation within (≤) 7 days of signing the ICF;
- Participation in another clinical trial within (≤) 30 days of signing the ICF (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 the Screening Visit or Day 1;
- Postponing a decision to quit using tobacco- or nicotine-containing products in order to participate in this study or a previous quit attempt within (≤) 30 days prior to signing the ICF;
- Drinks more than 21 servings of alcoholic beverages per week or has a positive alcohol test result at the Screening Visit or Day 1;
- Employed by a tobacco- or other nicotine-product manufacturing company, or the study site;
- Determined by the PI to be inappropriate for the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
High Point Clinical Trials Center
High Point, North Carolina, 27265
ICON Clinical Research
San Antonio, Texas, 78209
About this study
Official title: CSD1805: A Single-blind, Two-way Crossover Study to Assess Nicotine Uptake and Product Use Behavior in Moist Snuff Consumers Using Two Moist Snuff Products
The purpose of this study is to compare nicotine uptake and product use behavior during and following use of two moist snuff products in generally healthy, adult moist snuff users.
Read the detailed description
This will be an single-blind, multi-center, randomized, two-way crossover study, conducted in generally healthy, adult moist snuff users who will be randomly assigned to the order in which they will use two moist snuff study products (comparator product, test product). The study will evaluate pharmacokinetic (PK) measures for two moist snuff products in a 7-day confinement setting.
- Conditions
- Tobacco Use
- Being tested
- 1805AA, 1805AB
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1805AAOther
A moist snuff product
1805ABOther
A moist snuff product
| Study group | Role | What they receive |
|---|---|---|
| 1805AA, 1805AB Use Group | Experimental | Use of product 1805AA exclusively for approximately 3 days prior to a PK assessment, followed by use of product 1805AB exclusively for approximately 3 days prior to a PK assessment. Receives: Other: 1805AA; Other: 1805AB |
| 1805AB, 1805AA Use Group | Experimental | Use of product 1805AB exclusively for approximately 3 days prior to a PK assessment, followed by use of product 1805AA exclusively for approximately 3 days prior to a PK assessment. Receives: Other: 1805AA; Other: 1805AB |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCnic 0-240
area under the baseline-adjusted nicotine concentration- versus-time curve from time zero to 240 minutes after the start of Investigational Product (IP) use
Measured: -5, -1, 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, 150, 180, 210 and 240 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start19 Oct 2018
- Primary completion2 Dec 2018
- Study completion2 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco UseStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAI Services Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON Clinical Research
- Responsible party
- Sponsor
- Investigators
- Emanuel DeNoia, MD, Principal investigator, ICON Clinical ResearchMelanie Fein, MD, Principal investigator, High Point Clinical Trial Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03688776
- Sponsor's protocol ID
- CSD1805
- Status last verified
- Sep 2020
- First submitted
- 26 Sep 2018
- 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
- CSD1805: A Single-blind, Two-way Crossover Study to Assess Nicotine Uptake and Product Use Behavior in Moist Snuff Consumers Using Two Moist Snuff Products
- ClinicalTrials.gov ID
- NCT03688776
- Acronym / sponsor ID
- CSD1805
- Conditions
- Tobacco Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- RAI Services CompanyIndustry (pharma, biotech, devices)
- Collaborators
- ICON Clinical Research
- Study start
- 19 Oct 2018 (actual)
- Primary completion
- 2 Dec 2018 (actual)
- Study completion
- 2 Dec 2018 (actual)
- First posted
- 28 Sep 2018 (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.
The purpose of this study is to compare nicotine uptake and product use behavior during and following use of two moist snuff products in generally healthy, adult moist snuff users.
Detailed description
This will be an single-blind, multi-center, randomized, two-way crossover study, conducted in generally healthy, adult moist snuff users who will be randomly assigned to the order in which they will use two moist snuff study products (comparator product, test product). The study will evaluate pharmacokinetic (PK) measures for two moist snuff products in a 7-day confinement setting.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1805AA, 1805AB Use Group | Experimental | Other: 1805AA, Other: 1805ABUse of product 1805AA exclusively for approximately 3 days prior to a PK assessment, followed by use of product 1805AB exclusively for approximately 3 days prior to a PK assessment. |
| 1805AB, 1805AA Use Group | Experimental | Other: 1805AA, Other: 1805ABUse of product 1805AB exclusively for approximately 3 days prior to a PK assessment, followed by use of product 1805AA exclusively for approximately 3 days prior to a PK assessment. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 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 signing informed consent;
- Positive urine cotinine test at the Screening Visit and Day 1;
- Females must be willing to use a form of contraception acceptable to the Principal Investigator (PI) from the time of signing the ICF until study discharge;
- Subjects' primary tobacco product must be a moist snuff product. Dual use of other forms of tobacco- and/or nicotine-containing products will be allowed but not more frequently than four days per week;
Key exclusion criteria (19 listed)
- Presence of clinically significant or unstable/uncontrolled acute or chronic medical conditions at the time of signing the ICF, as determined by the PI, that would preclude a subject from participating safely in the study (e.g., uncontrolled hypertension, cardiac disease, neurological disease, psychiatric disorders) based on safety assessments such as clinical laboratory tests, pregnancy tests, medical history, and physical/oral examinations;
- History, presence of, or clinical laboratory test results indicating diabetes;
- Systolic blood pressure of > 160 mmHg or a diastolic blood pressure of > 95mmHg, measured after being seated for 5 minutes;
- Hemoglobin level < 12.5 g/dL for females and < 13.0 g/dL for males at the Screening Visit;
- Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV);
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 |
|---|---|---|
| 1805AAA moist snuff product | Other | 1805AA, 1805AB Use Group, 1805AB, 1805AA Use Group |
| 1805ABA moist snuff product | Other | 1805AA, 1805AB Use Group, 1805AB, 1805AA Use Group |
Primary outcome
AUCnic 0-240
Time frame: -5, -1, 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, 150, 180, 210 and 240 Minutes
area under the baseline-adjusted nicotine concentration- versus-time curve from time zero to 240 minutes after the start of Investigational Product (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.
Emanuel DeNoia, MD principal investigator
ICON Clinical Research
Melanie Fein, MD principal investigator
High Point Clinical Trial Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1805AA and 1805AB in people with Tobacco Use, 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 8 inclusion and 19 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 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?
AUCnic 0-240 (time frame: -5, -1, 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, 150, 180, 210 and 240 Minutes). 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.