SmokingNCT05081154
CSD201002: Study to Assess Nicotine Uptake From P10 Nicotine Pouches
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 study is a single-center, open-label, randomized, 7-way crossover study designed to evaluate plasma nicotine pharmacokinetics (PK) parameters following use of the study investigational products (IPs) in a confinement setting by generally healthy combustible cigarette (CC) smokers. 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
- 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
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2021to 24 Nov 2021
- 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 males or females, 21 to 60 years of age, inclusive, at the time of consent.
- Smokes combustible, filtered, non-menthol or menthol cigarettes, 83 mm to 100 mm in length as primary source of tobacco.
- Smokers who also use ST products (e.g., moist snuff, snus), and have used ST within 30 days prior to screening will be enrolled.
- Smokes an average of at least 10 cigarettes per day (CPD) and inhale the smoke, for at least 6 months prior to Screening. Brief periods of abstinence due to illness, 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.
- Agrees to smoke the same Usual Brand (UB) cigarette throughout the study period. The UB cigarette is defined as the reported cigarette brand and style currently smoked most frequently by the subject.
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- Expired breath carbon monoxide (ECO) level is ≥ 10 ppm and ≤ 100 ppm at Screening and at check-in Day 1.
- 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 "6-30 minutes" (Heatherton et al., 1991).
- Willing to use the UB cigarette and Velo Pouch IPs during the study period.
- Willing to abstain from tobacco and nicotine use for at least 12 hours prior to the start of each of seven Test Sessions.
- Females must be willing to use a form of contraception acceptable to the PI from the time of signing the informed consent until End-of-Study.
- Examples of acceptable means of birth control are, but not limited to: a) Surgical sterilization (hysterectomy, bilateral tubal ligation/occlusion, bilateral oophorectomy, bilateral salpingectomy); b) physical barrier method (e.g., condom, diaphragm/sponge/cervical cap) with spermicide; c) non-hormone releasing intrauterine devices (IUD) or hormone-releasing IUDs (e.g., Mirena or Kyleena); d) vasectomized partner; and e) post-menopausal and not on hormone replacement therapy.
- Agrees to an in-clinic confinement of 8 days (7 nights).
Who cannot join
- 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.
- 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.
- History or presence of bleeding or clotting disorders.
- 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.
- 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 check-in Day 1.
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- Weight of ≤ 110 pounds.
- Hemoglobin level is < 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 check-in Day 1.
- Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- 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 the signing of informed consent.
- Postpones a decision to quit using tobacco- or nicotine-containing products in order to participate in this study or self-reports a previous quit attempt within (≤) 30 days prior to the signing the informed consent.
- Any use of daily aspirin (≥ 325 mg/day) or any use of other anticoagulants.
- Individuals ≥ 35 years of age currently using systemic, estrogen-containing contraception or hormone replacement therapy.
- Whole blood donation within 8 weeks (≤ 56 days) prior to the signing of informed consent and between Screening and check-in Day 1.
- Plasma donation within (≤) 7 days prior to signing the informed consent and between Screening and check-in Day 1.
- Employed by a tobacco or nicotine company, the study site, or handles tobacco- or nicotine-containing products as part of their job.
- Participation in another clinical trial within (≤) 30 days prior to signing the 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 in the current study.
- Drinks more than 21 servings of alcoholic beverages per week
- Has a positive alcohol result at Screening or check-in Day 1.
- Determined by the PI to be inappropriate for this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An In-Clinic Confinement Study to Assess Nicotine Uptake From P10 Nicotine Pouches
This study is a single-center, open-label, randomized, 7-way crossover study designed to evaluate plasma nicotine pharmacokinetics (PK) parameters following use of the study investigational products (IPs) in a confinement setting by generally healthy combustible cigarette (CC) smokers.
Read the detailed description
This study is designed to evaluate plasma nicotine PK parameters following the use of nicotine pouches (hereinafter referred to as Velo Pouch IPs) in cigarette smokers and smokers who also use smokeless tobacco (SST) [e.g., snus, moist snuff]. At least one-third of the study population will include smokers who also use ST.
Potential subjects may complete a pre-screening telephone interview. They will complete a Screening Visit to assess their eligibility within 45 days prior to enrollment, randomization and confinement.
Following the Screening Visit, eligible subjects will be scheduled for a Day 1 check-in visit to complete procedures to confirm eligibility. Eligible subjects will be enrolled and begin confinement at the clinical site for 8 days and 7 nights. Subjects will participate in separate Test Sessions for plasma nicotine PK assessment, one for each IP. The IP for each Test Session will be determined based on a randomly assigned IP presentation schedule (14 product sequence) generated using a Williams Design. Each Test Session will last for approximately 4 hours following the start of the IP use, and will include collection of plasma samples for PK assessments prior to, during and following IP use and completion of the Overall Product Liking questionnaire. Subjects will use their randomized study IP one day before the respective test session to familiarize themselves with the IP.
- Conditions
- Smoking, Tobacco Use
- Being tested
- Product A, Product B, Product C, Product D, Product E
- Medical subject headings
- Smoking, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Product AOther
P1012915, a nicotine pouch with 8 mg nicotine
Product BOther
P1013018, a nicotine pouch with 10 mg nicotine
Product COther
P1013015, a nicotine pouch with 8 mg nicotine
Product DOther
P1012815, a nicotine pouch with 8 mg nicotine
Product EOther
P1013315, a nicotine pouch with 8 mg nicotine
Product FOther
P1013115, a nicotine pouch with 8 mg nicotine
Product GOther
P1013215, a nicotine pouch with 8 mg nicotine
| Study group | Role | What they receive |
|---|---|---|
| Product usage order A B G C F D E | Experimental | Subjects will use each of the 7 products (A B G C F D E) during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G |
| Product usage order B C A D G E F | Experimental | Subjects will use each of the 7 products (B C A D G E F) during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G |
| Product usage order C D B E A F G | Experimental | Subjects will use each of the 7 products (C D B E A F G) during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G |
| Product usage order D E C F B G A | Experimental | Subjects will use each of the 7 products (D E C F B G A) during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G |
| Product usage order E F D G C A B | Experimental | Subjects will use each of the 7 products (E F D G C A B) during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G |
| Product usage order F G E A D B C | Experimental | Subjects will use each of the 7 products (F G E A D B C) during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G |
| Product usage order G A F B E C D | Experimental | Subjects will use each of the 7 products (G A F B E C D) during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G |
| Product usage order E D F C G B A | Experimental | Subjects will use each of the 7 products (E D F C G B A) during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G |
| Product usage order F E G D A C B | Experimental | Subjects will use each of the 7 products (F E G D A C B) during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G |
| Product usage order G F A E B D C | Experimental | Subjects will use each of the 7 products (G F A E B D C) during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G |
| Product usage order A G B F C E D | Experimental | Subjects will use each of the 7 products (A G B F C E D) during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G |
| Product usage order B A C G D F E | Experimental | Subjects will use each of the 7 products (B A C G D F E) during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G |
| Product usage order C B D A E G F | Experimental | Subjects will use each of the 7 products (C B D A E G F) during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G |
| Product usage order D C E B F A G | Experimental | Subjects will use each of the 7 products (D C E B F A G) during an evaluation period, followed by a 4 hour Test Session Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D; Other: Product E; Other: Product F; Other: Product G |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC nic 0-240
Baseline-adjusted area under the plasma nicotine concentration-versus-time curve from time zero to 240 minutes after the start of IP use
Measured: 0 to 240 minutes
Cmax
Maximum baseline-adjusted plasma concentration of nicotine
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 posted18 Oct 2021
- Study start20 Oct 2021
- Primary completion24 Nov 2021
- Study completion24 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAI Services Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Milly Kanobe, PhD, Study director, RAIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05081154
- Sponsor's protocol ID
- CSD201002
- Status last verified
- Jun 2022
- First submitted
- 4 Oct 2021
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kanobe MN, Powell CY, Patrudu M, Baxter SA, Tapia MA, Darnell J, Prevette K, Gibson AG, Ayoku SA, Campbell L, Coffield JW, Keyser BM, Ganesh BS, Gale N, Jordan KG. Randomized crossover clinical studies to assess abuse liability and nicotine pharmacokinetics of Velo Oral Nicotine pouches. Front Pharmacol. 2025 Mar 13;16:1547073. doi: 10.3389/fphar.2025.1547073. eCollection 2025.
PubMed 40183092
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An In-Clinic Confinement Study to Assess Nicotine Uptake From P10 Nicotine Pouches
- ClinicalTrials.gov ID
- NCT05081154
- Acronym / sponsor ID
- CSD201002
- Conditions
- Smoking, Tobacco Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- RAI Services CompanyIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 24 Nov 2021 (actual)
- Study completion
- 24 Nov 2021 (actual)
- First posted
- 18 Oct 2021 (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 study is a single-center, open-label, randomized, 7-way crossover study designed to evaluate plasma nicotine pharmacokinetics (PK) parameters following use of the study investigational products (IPs) in a confinement setting by generally healthy combustible cigarette (CC) smokers.
Detailed description
This study is designed to evaluate plasma nicotine PK parameters following the use of nicotine pouches (hereinafter referred to as Velo Pouch IPs) in cigarette smokers and smokers who also use smokeless tobacco (SST) [e.g., snus, moist snuff]. At least one-third of the study population will include smokers who also use ST.
Potential subjects may complete a pre-screening telephone interview. They will complete a Screening Visit to assess their eligibility within 45 days prior to enrollment, randomization and confinement.
Following the Screening Visit, eligible subjects will be scheduled for a Day 1 check-in visit to complete procedures to confirm eligibility. Eligible subjects will be enrolled and begin confinement at the clinical site for 8 days and 7 nights. Subjects will participate in separate Test Sessions for plasma nicotine PK assessment, one for each IP. The IP for each Test Session will be determined based on a randomly assigned IP presentation schedule (14 product sequence) generated using a Williams Design. Each Test Session will last for approximately 4 hours following the start of the IP use, and will include collection of plasma samples for PK assessments prior to, during and following IP use and completion of the Overall Product Liking questionnaire. Subjects will use their randomized study IP one day before the respective test session to familiarize themselves with the IP.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Product usage order A B G C F D E | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product GSubjects will use each of the 7 products (A B G C F D E) during an evaluation period, followed by a 4 hour Test Session |
| Product usage order B C A D G E F | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product GSubjects will use each of the 7 products (B C A D G E F) during an evaluation period, followed by a 4 hour Test Session |
| Product usage order C D B E A F G | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product GSubjects will use each of the 7 products (C D B E A F G) during an evaluation period, followed by a 4 hour Test Session |
| Product usage order D E C F B G A | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product GSubjects will use each of the 7 products (D E C F B G A) during an evaluation period, followed by a 4 hour Test Session |
| Product usage order E F D G C A B | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product GSubjects will use each of the 7 products (E F D G C A B) during an evaluation period, followed by a 4 hour Test Session |
| Product usage order F G E A D B C | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product GSubjects will use each of the 7 products (F G E A D B C) during an evaluation period, followed by a 4 hour Test Session |
| Product usage order G A F B E C D | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product GSubjects will use each of the 7 products (G A F B E C D) during an evaluation period, followed by a 4 hour Test Session |
| Product usage order E D F C G B A | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product GSubjects will use each of the 7 products (E D F C G B A) during an evaluation period, followed by a 4 hour Test Session |
| Product usage order F E G D A C B | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product GSubjects will use each of the 7 products (F E G D A C B) during an evaluation period, followed by a 4 hour Test Session |
| Product usage order G F A E B D C | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product GSubjects will use each of the 7 products (G F A E B D C) during an evaluation period, followed by a 4 hour Test Session |
| Product usage order A G B F C E D | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product GSubjects will use each of the 7 products (A G B F C E D) during an evaluation period, followed by a 4 hour Test Session |
| Product usage order B A C G D F E | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product GSubjects will use each of the 7 products (B A C G D F E) during an evaluation period, followed by a 4 hour Test Session |
| Product usage order C B D A E G F | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product GSubjects will use each of the 7 products (C B D A E G F) during an evaluation period, followed by a 4 hour Test Session |
| Product usage order D C E B F A G | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product F, Other: Product GSubjects will use each of the 7 products (D C E B F A G) during an evaluation period, followed by a 4 hour Test Session |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Able to read, understand, and 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, non-menthol or menthol cigarettes, 83 mm to 100 mm in length as primary source of tobacco.
- Smokers who also use ST products (e.g., moist snuff, snus), and have used ST within 30 days prior to screening will be enrolled.
- Smokes an average of at least 10 cigarettes per day (CPD) and inhale the smoke, for at least 6 months prior to Screening. Brief periods of abstinence due to illness, 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.
Key exclusion criteria (22 listed)
- 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.
- 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.
- History or presence of bleeding or clotting disorders.
- 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.
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 AP1012915, a nicotine pouch with 8 mg nicotine | Other | Product usage order A B G C F D E, Product usage order A G B F C E D, Product usage order B A C G D F E, Product usage order B C A D G E F, Product usage order C B D A E G F, Product usage order C D B E A F G, Product usage order D C E B F A G, Product usage order D E C F B G A, Product usage order E D F C G B A, Product usage order E F D G C A B, Product usage order F E G D A C B, Product usage order F G E A D B C, Product usage order G A F B E C D, Product usage order G F A E B D C |
| Product BP1013018, a nicotine pouch with 10 mg nicotine | Other | Product usage order A B G C F D E, Product usage order A G B F C E D, Product usage order B A C G D F E, Product usage order B C A D G E F, Product usage order C B D A E G F, Product usage order C D B E A F G, Product usage order D C E B F A G, Product usage order D E C F B G A, Product usage order E D F C G B A, Product usage order E F D G C A B, Product usage order F E G D A C B, Product usage order F G E A D B C, Product usage order G A F B E C D, Product usage order G F A E B D C |
| Product CP1013015, a nicotine pouch with 8 mg nicotine | Other | Product usage order A B G C F D E, Product usage order A G B F C E D, Product usage order B A C G D F E, Product usage order B C A D G E F, Product usage order C B D A E G F, Product usage order C D B E A F G, Product usage order D C E B F A G, Product usage order D E C F B G A, Product usage order E D F C G B A, Product usage order E F D G C A B, Product usage order F E G D A C B, Product usage order F G E A D B C, Product usage order G A F B E C D, Product usage order G F A E B D C |
| Product DP1012815, a nicotine pouch with 8 mg nicotine | Other | Product usage order A B G C F D E, Product usage order A G B F C E D, Product usage order B A C G D F E, Product usage order B C A D G E F, Product usage order C B D A E G F, Product usage order C D B E A F G, Product usage order D C E B F A G, Product usage order D E C F B G A, Product usage order E D F C G B A, Product usage order E F D G C A B, Product usage order F E G D A C B, Product usage order F G E A D B C, Product usage order G A F B E C D, Product usage order G F A E B D C |
| Product EP1013315, a nicotine pouch with 8 mg nicotine | Other | Product usage order A B G C F D E, Product usage order A G B F C E D, Product usage order B A C G D F E, Product usage order B C A D G E F, Product usage order C B D A E G F, Product usage order C D B E A F G, Product usage order D C E B F A G, Product usage order D E C F B G A, Product usage order E D F C G B A, Product usage order E F D G C A B, Product usage order F E G D A C B, Product usage order F G E A D B C, Product usage order G A F B E C D, Product usage order G F A E B D C |
| Product FP1013115, a nicotine pouch with 8 mg nicotine | Other | Product usage order A B G C F D E, Product usage order A G B F C E D, Product usage order B A C G D F E, Product usage order B C A D G E F, Product usage order C B D A E G F, Product usage order C D B E A F G, Product usage order D C E B F A G, Product usage order D E C F B G A, Product usage order E D F C G B A, Product usage order E F D G C A B, Product usage order F E G D A C B, Product usage order F G E A D B C, Product usage order G A F B E C D, Product usage order G F A E B D C |
| Product GP1013215, a nicotine pouch with 8 mg nicotine | Other | Product usage order A B G C F D E, Product usage order A G B F C E D, Product usage order B A C G D F E, Product usage order B C A D G E F, Product usage order C B D A E G F, Product usage order C D B E A F G, Product usage order D C E B F A G, Product usage order D E C F B G A, Product usage order E D F C G B A, Product usage order E F D G C A B, Product usage order F E G D A C B, Product usage order F G E A D B C, Product usage order G A F B E C D, Product usage order G F A E B D C |
Primary outcome
AUC nic 0-240
Time frame: 0 to 240 minutes
Baseline-adjusted area under the plasma nicotine concentration-versus-time curve from time zero to 240 minutes after the start of IP use
Cmax
Time frame: 240 minutes
Maximum baseline-adjusted plasma concentration of nicotine
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 27 Jun 2022.
- Derived from this study: PubMed 40183092Kanobe MN, Powell CY, Patrudu M, Baxter SA, Tapia MA, Darnell J, Prevette K, Gibson AG, Ayoku SA, Campbell L, Coffield JW, Keyser BM, Ganesh BS, Gale N, Jordan KG. Randomized crossover clinical studies to assess abuse liability and nicotine pharmacokinetics of Velo Oral Nicotine pouches. Front Pharmacol. 2025 Mar 13;16:1547073. doi: 10.3389/fphar.2025.1547073. eCollection 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.
Milly Kanobe, PhD 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 14 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 27 Jun 2022. 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?
AUC nic 0-240 (time frame: 0 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?
On the ClinicalTrials.gov record for NCT05081154, which also lists 1 linked publication.
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 27 Jun 2022.