Tobacco UseNCT06303115
CSD231005 Nicotine Pouch Biomarkers of Exposure
A study testing Nicotine Pouch P1312914, 4 mg nicotine, Nicotine Pouch P1312915, 8 mg nicotine and Nicotine Pouch P1013215, 8 mg nicotine in people with Tobacco Use and Smoking, run by RAI Services Company at 5 sites in United States.
Trial summary
This will be a multi center open label, randomized, controlled, switching parallel-group study designed to assess changes in select biomarkers of exposure (BoE) in generally healthy smokers following a 5 day in-clinic switch to use of nicotine Pouch investigational products (IPs) compared to continued usual brand (UB)… 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, Smoking
- What is being tested?
- Nicotine Pouch P1312914, 4 mg nicotine, Nicotine Pouch P1312915, 8 mg nicotine and Nicotine Pouch P1013215, 8 mg nicotine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 5 sitesUnited States
- Study dates
- 22 Aug 2024to 15 Jan 2025
- 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 be willing to sign an Informed Consent Form (ICF) and complete questionnaires written in English.
- Generally healthy males or females, 21 to 60 years of age, inclusive, at the time of consent.
- Smokes combustible, filtered, nonmenthol or menthol cigarettes, 83 mm to 100 mm in length.
- Smokes an average of at least 10 cigarettes per day (CPD) and inhales the smoke for at least six months prior to Screening. Brief periods of abstinence due to illness, a 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 PI.
- Self-reports that cigarettes are their primary tobacco- or nicotine-containing product use within 30 days of Screening. (Note: occasional use of other tobacco- or nicotine-containing products may be acceptable in consultation with the Sponsor);
- Agrees to use assigned IP throughout the study period.
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- Expired breath carbon monoxide (ECO) level ≥ 10 ppm and ≤ 100 ppm at Screening and at CheckIn on Day 2.
- Positive urine cotinine test at Screening.
- Response at Screening to the 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 "630 minutes." (Heatherton, Kozlowski, Frecker, \& Fagerstrom, 1991).
- Willing to switch from current UB cigarette to either nicotine Pouch IP, or abstain from smoking, for approximately 5 days during in-clinic confinement;
- Females must be willing to use a form of contraception acceptable to the PI from the time of signing the informed consent until the End of Study (EOS).
- Examples of acceptable means of birth control are, but not limited to:
- Surgical sterilization (hysterectomy, bilateral tubal ligation/occlusion, bilateral oophorectomy, bilateral salpingectomy);
- Established use of oral, implantable, injectable or transdermal methods of contraception associated with inhibition of ovulation (see Section 6.10 regarding the use of hormonal methods of contraception in females aged ≥ 35);
- Physical barrier method (e.g., condom, diaphragm/sponge/cervical cap) with spermicide;
- Non-hormone releasing intrauterine devices (IUD) or hormone-releasing IUDs (e.g., Mirena or Kyleena) (see Section 6.10 regarding the use of hormonal methods of contraception in females aged ≥ 35);
- Vasectomized partner;
- Abstinence from heterosexual intercourse (as a lifestyle choice, not just for the purpose of study participation); and
- Post-menopausal and not on hormone replacement therapy.
- Males must be willing to use a barrier method of contraception (e.g., a condom with spermicide) or to refrain from donating sperm from the time of signing the informed consent until the EOS, unless they had undergone a vasectomy or were abstinent from heterosexual intercourse, or their female partner was not able to bear children.
- Willing to refrain from consuming cruciferous vegetables and grilled, smoked, fried or barbequed food, and to avoid being in the presence of the cooking of these foods. Subjects should also be willing to refrain from consuming cured sandwich meats, bacon, salami, and sausages 48 hours prior to CheckIn on Day 2.
- Agrees to inclinic confinement of 8 days (7 nights).
Who cannot join
- The 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 subject unsuitable to participate in this clinical study.
- History, presence of, or clinical laboratory test results indicating diabetes. Fasting plasma glucose > 126 mg/dL (7 mmol/L) is exclusionary. One recheck may be performed for fasting plasma glucose values > 126 mg/dL but < 200 mg/dL.
- Scheduled treatment for asthma currently or within the past 12 consecutive months prior to Screening. As needed treatment, such as inhalers, may be included at the PI's discretion, pending approval from the Medical Monitor.
- Use of any medications that interfere with the cyclooxygenase pathway (e.g., antiinflammatoryanti-inflammatory drugs such as aspirin and ibuprofen) 14 days prior to CheckIn on Day 2.
- Use of medications or substances (other than nicotine) known to be strong inducers or inhibitors of cytochrome P450 (CYP) enzymes within 14 days or 5 halflives of the medication or substances (whichever is longer) prior to CheckIn on Day 2.
- History or presence of bleeding or clotting disorders.
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- Any history of cancer, except for primary cancers of the skin, such as localized basal cell/squamous cell carcinoma, that have been surgically and/or cryogenically removed.
- Systolic blood pressure (BP) of > 160 mmHg or a diastolic BP of > 95 mmHg, measured after being seated for 5 minutes at Screening and CheckIn on Day 2.
- Body Mass Index (BMI) < 18.0 or >40.0 kg/m2 (weight of ≤ 110 pounds) at Screening.
- Hemoglobin level < 12.5 g/dL for females or <13.0 g/dL for males at Screening.
- Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the course of the study.
- A positive urine drug screen without evidence of prescribed corresponding concomitant medication(s) at Screening or CheckIn on Day 2.
- Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBbsAg), or hepatitis C virus (HCV).
- 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 of the ICF.
- Postpones a decision to quit using tobacco or nicotinecontaining products to participate in this study or has made a previous quit attempt within (≤) 30 days prior to the signing of the ICF.
- Any daily use of aspirin (≥ 325 mg/day) or anticoagulants (e.g., Clopidogrel [Plavix®], Warfarin [Coumadin®, Jantoven®]).
- Individuals ≥ 35 years of age currently using systemic, estrogencontaining contraception or hormone replacement therapy.
- Whole blood donation within 8 weeks (≤ 56 days) prior to the signing of the ICF.
- NOTE: Subjects will be advised against scheduling a whole blood donation for at least 7 days following study completion.
- Plasma donation within (≤) 7 days prior to the ICF. NOTE: Subjects will be advised against scheduling a plasma donation for at least 7 days following study completion.
- Employed by a tobacco or nicotine company, the study site, or handles tobacco or nicotinecontaining products as part of their job.
- Participation in another clinical trial within (≤) 30 days prior to the signing of the ICF. The 30day 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.
- Drinks more than 21 servings of alcoholic beverages per week.
- Has a positive alcohol result at Screening or CheckIn on Day 2.
- Determined by the PI to be inappropriate for this study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Pillar Bentonville
Bentonville, Arkansas, 72712
AMR Knoxville
Knoxville, Tennessee, 37920
AMR Lexington
Lexington, Kentucky, 40509
Pillar Richardson
Richardson, Texas, 75080
QPS Missouri
Springfield, Missouri, 65802
About this study
Official title: A Multi Site, Open Label, Parallel Group Study to Assess Changes in Tobacco Related Biomarkers of Exposure Following Switching From Smoking of Combustible Cigarettes to Exclusive Use of Nicotine Pouches in Adult Smokers
This will be a multi center open label, randomized, controlled, switching parallel-group study designed to assess changes in select biomarkers of exposure (BoE) in generally healthy smokers following a 5 day in-clinic switch to use of nicotine Pouch investigational products (IPs) compared to continued usual brand (UB) cigarette smoking or smoking abstinence.
- Conditions
- Tobacco Use, Smoking
- Being tested
- Nicotine Pouch P1312914, 4 mg nicotine, Nicotine Pouch P1312915, 8 mg nicotine, Nicotine Pouch P1013215, 8 mg nicotine, Nicotine Pouch P1013218, 10 mg nicotine, Nicotine Pouch P1012919, 12 mg nicotine
- Medical subject headings
- Tobacco Use, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine Pouch P1312914, 4 mg nicotineOther
P1312914 pouch product
Nicotine Pouch P1312915, 8 mg nicotineOther
P1312915 pouch product
Nicotine Pouch P1013215, 8 mg nicotineOther
P1013215 pouch product
Nicotine Pouch P1013218, 10 mg nicotineOther
P1013218 pouch product
Nicotine Pouch P1012919, 12 mg nicotineOther
P1012919 pouch product
Smoking AbstinenceOther
No tobacco/nicotine
Continued UB cigarette smokingOther
Usual Brand Cigarette
| Study group | Role | What they receive |
|---|---|---|
| Nicotine Pouch P1312914, 4 mg nicotine | Active comparator | Subjects will be switched to exclusive use of their assigned pouch flavor and strength. Receives: Other: Nicotine Pouch P1312914, 4 mg nicotine |
| Nicotine Pouch P1312915, 8 mg nicotine | Active comparator | Subjects will be switched to exclusive use of their assigned pouch flavor and strength. Receives: Other: Nicotine Pouch P1312915, 8 mg nicotine |
| Nicotine Pouch P1013215, 8 mg nicotine | Active comparator | Subjects will be switched to exclusive use of their assigned pouch flavor and strength. Receives: Other: Nicotine Pouch P1013215, 8 mg nicotine |
| Nicotine Pouch P1013218, 10 mg nicotine | Active comparator | Subjects will be switched to exclusive use of their assigned pouch flavor and strength. Receives: Other: Nicotine Pouch P1013218, 10 mg nicotine |
| Nicotine Pouch P1012919, 12 mg nicotine | Active comparator | Subjects will be switched to exclusive use of their assigned pouch flavor and strength. Receives: Other: Nicotine Pouch P1012919, 12 mg nicotine |
| Smoking Abstinence | Other | Subjects will not use any tobacco or nicotine containing products. Receives: Other: Smoking Abstinence |
| Continued UB cigarette smoking | Other | Subjects will continue use of their Usual Brand Cigarettes. Receives: Other: Continued UB cigarette smoking |
What is being measured
The primary outcome is the main question the study is designed to answer.
4(methylnitrosamino)1(3pyridyl)1butanol [NNAL] + glucuronides [Total NNAL]
Measured: 24 hour
Secondary outcomes (14)
4Aminobiphenyl [4ABP]
Measured: 24 hour
1Aminonaphthalene [1AN]
Measured: 24 hour
2Aminonaphthalene [2AN]
Measured: 24 hour
2Cyanoethyl mercapturic acid [CEMA]
Measured: 24 hour
3Hydroxypropyl mercapturic acid [3HPMA]
Measured: 24 hour
3Hydroxy1methylpropylmercapturic acid [HMPMA]
Measured: 24 hour
3hydroxybenzo[a]pyrene [3-OH-B[a]P]
Measured: 24 hour
1hydroxypyrene [1OHP]
Measured: 24 hour
Monohydroxybutyl mercapturic acid [MHBMA]
Measured: 24 hour
Nnitrosonornicotine [NNN] + glucuronides [Total NNN]
Measured: 24 hour
SPhenyl mercapturic acid [SPMA]
Measured: 24 hour
Total nicotine equivalents (molar sum of nicotine, cotinine, 3hydroxycotinine and their glucuronides) [TNneq]
Measured: 24 hour
Carboxyhemoglobin [COHb]
Measured: 12 hour
Nnitrosonornicotine [NNN] + glucuronides [Total NNN]
Measured: 12 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start22 Aug 2024
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAI Services Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Keyser, PhD, Principal investigator, Reynolds American
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303115
- Sponsor's protocol ID
- CSD231005 BoE
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 11 Apr 2025
- 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 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi Site, Open Label, Parallel Group Study to Assess Changes in Tobacco Related Biomarkers of Exposure Following Switching From Smoking of Combustible Cigarettes to Exclusive Use of Nicotine Pouches in Adult Smokers
- ClinicalTrials.gov ID
- NCT06303115
- Acronym / sponsor ID
- CSD231005 BoE
- Conditions
- Tobacco Use, Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- RAI Services CompanyIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 12 Mar 2024 (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 will be a multi center open label, randomized, controlled, switching parallel-group study designed to assess changes in select biomarkers of exposure (BoE) in generally healthy smokers following a 5 day in-clinic switch to use of nicotine Pouch investigational products (IPs) compared to continued usual brand (UB) cigarette smoking or smoking abstinence.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Nicotine Pouch P1312914, 4 mg nicotine | Active comparator | Other: Nicotine Pouch P1312914, 4 mg nicotineSubjects will be switched to exclusive use of their assigned pouch flavor and strength. |
| Nicotine Pouch P1312915, 8 mg nicotine | Active comparator | Other: Nicotine Pouch P1312915, 8 mg nicotineSubjects will be switched to exclusive use of their assigned pouch flavor and strength. |
| Nicotine Pouch P1013215, 8 mg nicotine | Active comparator | Other: Nicotine Pouch P1013215, 8 mg nicotineSubjects will be switched to exclusive use of their assigned pouch flavor and strength. |
| Nicotine Pouch P1013218, 10 mg nicotine | Active comparator | Other: Nicotine Pouch P1013218, 10 mg nicotineSubjects will be switched to exclusive use of their assigned pouch flavor and strength. |
| Nicotine Pouch P1012919, 12 mg nicotine | Active comparator | Other: Nicotine Pouch P1012919, 12 mg nicotineSubjects will be switched to exclusive use of their assigned pouch flavor and strength. |
| Smoking Abstinence | Other | Other: Smoking AbstinenceSubjects will not use any tobacco or nicotine containing products. |
| Continued UB cigarette smoking | Other | Other: Continued UB cigarette smokingSubjects will continue use of their Usual Brand Cigarettes. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (22 listed)
- Able to read, understand, and be willing to sign an Informed Consent Form (ICF) and complete questionnaires written in English.
- Generally healthy males or females, 21 to 60 years of age, inclusive, at the time of consent.
- Smokes combustible, filtered, nonmenthol or menthol cigarettes, 83 mm to 100 mm in length.
- Smokes an average of at least 10 cigarettes per day (CPD) and inhales the smoke for at least six months prior to Screening. Brief periods of abstinence due to illness, a 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 PI.
- Self-reports that cigarettes are their primary tobacco- or nicotine-containing product use within 30 days of Screening. (Note: occasional use of other tobacco- or nicotine-containing products may be acceptable in consultation with the Sponsor);
Key exclusion criteria (25 listed)
- The 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 subject unsuitable to participate in this clinical study.
- History, presence of, or clinical laboratory test results indicating diabetes. Fasting plasma glucose > 126 mg/dL (7 mmol/L) is exclusionary. One recheck may be performed for fasting plasma glucose values > 126 mg/dL but < 200 mg/dL.
- Scheduled treatment for asthma currently or within the past 12 consecutive months prior to Screening. As needed treatment, such as inhalers, may be included at the PI's discretion, pending approval from the Medical Monitor.
- Use of any medications that interfere with the cyclooxygenase pathway (e.g., antiinflammatoryanti-inflammatory drugs such as aspirin and ibuprofen) 14 days prior to CheckIn on Day 2.
- Use of medications or substances (other than nicotine) known to be strong inducers or inhibitors of cytochrome P450 (CYP) enzymes within 14 days or 5 halflives of the medication or substances (whichever is longer) prior to CheckIn on Day 2.
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 |
|---|---|---|
| Nicotine Pouch P1312914, 4 mg nicotineP1312914 pouch product | Other | Nicotine Pouch P1312914, 4 mg nicotine |
| Nicotine Pouch P1312915, 8 mg nicotineP1312915 pouch product | Other | Nicotine Pouch P1312915, 8 mg nicotine |
| Nicotine Pouch P1013215, 8 mg nicotineP1013215 pouch product | Other | Nicotine Pouch P1013215, 8 mg nicotine |
| Nicotine Pouch P1013218, 10 mg nicotineP1013218 pouch product | Other | Nicotine Pouch P1013218, 10 mg nicotine |
| Nicotine Pouch P1012919, 12 mg nicotineP1012919 pouch product | Other | Nicotine Pouch P1012919, 12 mg nicotine |
| Smoking AbstinenceNo tobacco/nicotine | Other | Smoking Abstinence |
| Continued UB cigarette smokingUsual Brand Cigarette | Other | Continued UB cigarette smoking |
Primary outcome
4(methylnitrosamino)1(3pyridyl)1butanol [NNAL] + glucuronides [Total NNAL]
Time frame: 24 hour
14 secondary outcomes
4Aminobiphenyl [4ABP]
Time frame: 24 hour
1Aminonaphthalene [1AN]
Time frame: 24 hour
2Aminonaphthalene [2AN]
Time frame: 24 hour
2Cyanoethyl mercapturic acid [CEMA]
Time frame: 24 hour
3Hydroxypropyl mercapturic acid [3HPMA]
Time frame: 24 hour
3Hydroxy1methylpropylmercapturic acid [HMPMA]
Time frame: 24 hour
3hydroxybenzo[a]pyrene [3-OH-B[a]P]
Time frame: 24 hour
1hydroxypyrene [1OHP]
Time frame: 24 hour
Monohydroxybutyl mercapturic acid [MHBMA]
Time frame: 24 hour
Nnitrosonornicotine [NNN] + glucuronides [Total NNN]
Time frame: 24 hour
SPhenyl mercapturic acid [SPMA]
Time frame: 24 hour
Total nicotine equivalents (molar sum of nicotine, cotinine, 3hydroxycotinine and their glucuronides) [TNneq]
Time frame: 24 hour
Carboxyhemoglobin [COHb]
Time frame: 12 hour
Nnitrosonornicotine [NNN] + glucuronides [Total NNN]
Time frame: 12 hour
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 11 Apr 2025.
- 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.
Brian Keyser, PhD principal investigator
Reynolds American
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine Pouch P1312914, 4 mg nicotine, Nicotine Pouch P1312915, 8 mg nicotine and Nicotine Pouch P1013215, 8 mg nicotine in people with Tobacco Use and Smoking, run by RAI Services Company at 5 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 22 inclusion and 25 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 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
4(methylnitrosamino)1(3pyridyl)1butanol [NNAL] + glucuronides [Total NNAL] (time frame: 24 hour). 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 11 Apr 2025.