Tobacco UseNCT03993769
CSD190101: A Study to Assess Nicotine Pharmacokinetic Parameters After Use of Two Smokeless Tobacco Products
A study testing A19010-F and B19010-F in people with Tobacco Use, run by RAI Services Company at 6 sites in United States.
Trial summary
The purpose of this study is to compare plasma nicotine uptake in adult snus consumers after using investigational snus products (A19010-F and B19010-F). 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?
- A19010-F and B19010-F
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 6 sitesUnited States
- Study dates
- 9 Jul 2019to 31 Aug 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;
- Generally healthy male or female, 21 to 60 years of age, inclusive, at the time of signing the ICF;
- Positive urine cotinine test at the Screening Visit and Day 1;
- Childbearing 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; acceptable methods include:
- Female subjects who are heterosexually active and of childbearing potential (e.g., neither surgically sterile postmenopausal) must have been using one of the following forms of contraception for the time period indicated and agree to continue using it through completion of the study:
- Hormonal (e.g., oral, vaginal ring, transdermal patch, implant, injection) consistently for at least 3 months prior to Check-in
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- Double barrier (i.e., condom with spermicide or diaphragm with spermicide) consistently for at least 4 weeks prior to Check-in
- Intrauterine device for at least 4 months prior to Check-in
- Exclusive partner who has been vasectomized for at least 6 months (inclusive) prior to Check-in
- Female subjects of childbearing potential who are not currently engaging
- In heterosexual intercourse must agree to use one of the above methods of birth control through completion of study, in the event that they have heterosexual intercourse during the course of the study.
- Female subjects who are of non-childbearing potential must have undergone one of the following sterilization procedures at least 6 months prior to Check in:
- Hysteroscopic sterilization (including Essure® or similar nonsurgical sterilization procedures);
- Bilateral tubal ligation or bilateral salpingectomy
- Hysterectomy
- Bilateral oophorectomy
- Subjects' primary tobacco product must be a mint or mint-like flavor of snus. Poly use of other (non-snus) forms of tobacco- and/or nicotine-containing products will be allowed if frequency of use of other products is less than or equal to four days per week (e.g., vaping) OR less than or equal to 15 cigarettes per week.
- Self-reports currently using at least one container of their usual brand (UB) snus per week for at least 3 months prior to randomization;
- Agrees to exclusively use the IP and not use any other tobacco- or nicotine-containing product during the study;
- Willing to comply with the requirements of the study;
- Able to safely perform the required study procedures, as determined by the PI.
Who cannot join
- Presence of clinically significant uncontrolled cardiovascular, chronic 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;
- Hemoglobin level < 11.0 g/dL for females and < 12.0 g/dL for males at the Screening Visit;
- History or presence of bleeding or clotting disorders;
- Daily use of aspirin (> 325mg/day) or anticoagulants;
- Whole blood donation within 8 weeks (≤ 56 days) prior to the signing the ICF;
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- Plasma donation within (≤) 7 days of signing the ICF;
- Systolic blood pressure of > 160 mmHg or a diastolic blood pressure of > 95 mmHg, measured after being seated for 5 minutes;
- Weight of ≤ 110 pounds;
- 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 have 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 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 study;
- A positive urine drug screen without evidence of prescribed corresponding acceptable concomitant medication(s) at the Screening Visit or at check-in on Day 1;
- Postponing a decision to quit using tobacco- or nicotine-containing products 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 breathalyzer result at the Screening Visit and check-in on Day 1;
- Employed by a tobacco- or other nicotine-product manufacturing company, or the study site, or handles tobacco- or nicotine-containing products as part of their job;
- Presence of gum bleeding and/or abscess, open mouth sores or oral ulcers at Screening, Check-in, or prior to Day 5 product use (just prior to switching IP);
- Full dentures or braces (with the exception of night guard/retainer, and dental implants which may be allowed; if subjects is missing all lower teeth and does not use dentures will also be allowed);
- Determined by the PI to be inappropriate for the study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
High Point Clinical Trials Center
High Point, North Carolina, 27265
New Orleans Center for Clinical Research (NOCCR)
Knoxville, Tennessee, 37920
Central Kentucky Research
Lexington, Kentucky, 40509
Woodland Research Northwest, LLC
Rogers, Arkansas, 72758
QPS Bio-Kinetic
Springfield, Missouri, 65802
Spaulding Clinical Research, LLC
West Bend, Wisconsin, 53095
About this study
Official title: CSD190101: An Unblinded, Randomized, Multi-site, Two-way Crossover Study to Assess Nicotine Pharmacokinetic Parameters After Use of Two Smokeless Tobacco Products A19010-F and B19010-F in Healthy Adult Snus Consumers.
The purpose of this study is to compare plasma nicotine uptake in adult snus consumers after using investigational snus products (A19010-F and B19010-F).
Read the detailed description
This will be an unblinded, randomized, multi-site, two-way crossover study to assess nicotine pharmacokinetic parameters after use of two smokeless tobacco products A19010-F and B19010-F in healthy adult snus consumers. Eligible subjects will be confined to the site for 9 days and randomized to one of two investigational product (IP) (A: A19010-F and B: B19010-F) use sequences (AB/BA). Each subject will use a single product exclusively for 4 days prior to a PK assessment for plasma nicotine concentrations, and then subjects will use the other product exclusively for 4 days prior to a PK assessment for plasma nicotine concentrations.
- Conditions
- Tobacco Use
- Being tested
- A19010-F, B19010-F
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A19010-FOther
A snus product
B19010-FOther
A snus product
| Study group | Role | What they receive |
|---|---|---|
| A19010-F, B19010-F Use Group | Experimental | Use of product A19010-F exclusively for 4 days prior to a PK assessment for plasma nicotine concentrations, followed by use of product B19010-F exclusively for 4 days prior to a PK assessment for plasma nicotine concentrations. Receives: Other: A19010-F; Other: B19010-F |
| B19010-F, A19010-F Use Group | Experimental | Use of product B19010-F exclusively for 4 days prior to a PK assessment for plasma nicotine concentrations, followed by use of product A19010-F exclusively for 4 days prior to a PK assessment for plasma nicotine concentrations. Receives: Other: A19010-F; Other: B19010-F |
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 a 30-minute single IP use period.
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 posted21 Jun 2019
- Study start9 Jul 2019
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
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
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAI Services Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
- Investigators
- Jason Hong, MD, Study director, RAIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993769
- Sponsor's protocol ID
- CSD190101
- Status last verified
- Oct 2019
- First submitted
- 19 Jun 2019
- Last updated
- 25 Oct 2019
- 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 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSD190101: An Unblinded, Randomized, Multi-site, Two-way Crossover Study to Assess Nicotine Pharmacokinetic Parameters After Use of Two Smokeless Tobacco Products A19010-F and B19010-F in Healthy Adult Snus Consumers.
- ClinicalTrials.gov ID
- NCT03993769
- Acronym / sponsor ID
- CSD190101
- Conditions
- Tobacco Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- RAI Services CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- 9 Jul 2019 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 21 Jun 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.
The purpose of this study is to compare plasma nicotine uptake in adult snus consumers after using investigational snus products (A19010-F and B19010-F).
Detailed description
This will be an unblinded, randomized, multi-site, two-way crossover study to assess nicotine pharmacokinetic parameters after use of two smokeless tobacco products A19010-F and B19010-F in healthy adult snus consumers. Eligible subjects will be confined to the site for 9 days and randomized to one of two investigational product (IP) (A: A19010-F and B: B19010-F) use sequences (AB/BA). Each subject will use a single product exclusively for 4 days prior to a PK assessment for plasma nicotine concentrations, and then subjects will use the other product exclusively for 4 days prior to a PK assessment for plasma nicotine concentrations.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A19010-F, B19010-F Use Group | Experimental | Other: A19010-F, Other: B19010-FUse of product A19010-F exclusively for 4 days prior to a PK assessment for plasma nicotine concentrations, followed by use of product B19010-F exclusively for 4 days prior to a PK assessment for plasma nicotine concentrations. |
| B19010-F, A19010-F Use Group | Experimental | Other: A19010-F, Other: B19010-FUse of product B19010-F exclusively for 4 days prior to a PK assessment for plasma nicotine concentrations, followed by use of product A19010-F exclusively for 4 days prior to a PK assessment for plasma nicotine concentrations. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires;
- Generally healthy male or female, 21 to 60 years of age, inclusive, at the time of signing the ICF;
- Positive urine cotinine test at the Screening Visit and Day 1;
- Childbearing 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; acceptable methods include:
- Female subjects who are of non-childbearing potential must have undergone one of the following sterilization procedures at least 6 months prior to Check in:
Key exclusion criteria (21 listed)
- Presence of clinically significant uncontrolled cardiovascular, chronic 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;
- Hemoglobin level < 11.0 g/dL for females and < 12.0 g/dL for males at the Screening Visit;
- History or presence of bleeding or clotting disorders;
- Daily use of aspirin (> 325mg/day) or anticoagulants;
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 |
|---|---|---|
| A19010-FA snus product | Other | A19010-F, B19010-F Use Group, B19010-F, A19010-F Use Group |
| B19010-FA snus product | Other | A19010-F, B19010-F Use Group, B19010-F, A19010-F Use Group |
Primary outcome
AUCnic 0-240
Time frame: 240 minutes
Area under the baseline-adjusted nicotine concentration-versus-time curve from time zero to 240 minutes after the start of a 30-minute single IP use period.
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 Oct 2019.
- 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
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A19010-F and B19010-F in people with Tobacco Use, run by RAI Services Company at 6 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 21 inclusion and 21 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 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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: 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 Oct 2019; AzTrials last refreshed its copy on 1 Nov 2026.