CompletedNCT05081154Updated Jun 27, 2022

CSD201002: Study to Assess Nicotine Uptake From P10 Nicotine Pouches

An interventional study of Product A and Product B in Smoking and Tobacco Use, sponsored by RAI Services Company. Completed at 1 site in United States. Open to participants aged 21 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-27.

Sponsored by RAI Services Company (part of British American Tobacco) · Not applicable, Interventional, and Other

Phase: Not applicable
Study type: Interventional
Enrollment: 36
Allocation: Randomized
Ages: 21 Years to 60 Years
Sex: All

Study 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 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 studied

Smoking
Tobacco Use

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In context

Smoking

325 studies on the registry are indexed under Smoking; 141 are open to participants now.

This study's enrollment of 36 is below the median of 117 across 250 interventional studies indexed under Smoking.

Browse Smoking studies →

Lead sponsor

RAI Services Company is the lead sponsor of 53 studies on the registry; 12 are open to participants now.

First submitted after RAI Services Company became part of British American Tobacco.

Browse RAI Services Company studies →All British American Tobacco studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 21 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.
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).

Exclusion criteria

Exclusion Criteria:

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.
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.

Study design

Phase: Not applicable
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 36 participants (actual)

Study arms

Experimental
Product usage order A B G C F D E
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
Other: Product A · Other: Product B · Other: Product C · Other: Product D · Other: Product E · Other: Product F · Other: Product G
Experimental
Product usage order B C A D G E F
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
Other: Product A · Other: Product B · Other: Product C · Other: Product D · Other: Product E · Other: Product F · Other: Product G
Experimental
Product usage order C D B E A F G
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
Other: Product A · Other: Product B · Other: Product C · Other: Product D · Other: Product E · Other: Product F · Other: Product G
Experimental
Product usage order D E C F B G A
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
Other: Product A · Other: Product B · Other: Product C · Other: Product D · Other: Product E · Other: Product F · Other: Product G
Experimental
Product usage order E F D G C A B
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
Other: Product A · Other: Product B · Other: Product C · Other: Product D · Other: Product E · Other: Product F · Other: Product G
Experimental
Product usage order F G E A D B C
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
Other: Product A · Other: Product B · Other: Product C · Other: Product D · Other: Product E · Other: Product F · Other: Product G
Experimental
Product usage order G A F B E C D
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
Other: Product A · Other: Product B · Other: Product C · Other: Product D · Other: Product E · Other: Product F · Other: Product G
Experimental
Product usage order E D F C G B A
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
Other: Product A · Other: Product B · Other: Product C · Other: Product D · Other: Product E · Other: Product F · Other: Product G
Experimental
Product usage order F E G D A C B
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
Other: Product A · Other: Product B · Other: Product C · Other: Product D · Other: Product E · Other: Product F · Other: Product G
Experimental
Product usage order G F A E B D C
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
Other: Product A · Other: Product B · Other: Product C · Other: Product D · Other: Product E · Other: Product F · Other: Product G
Experimental
Product usage order A G B F C E D
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
Other: Product A · Other: Product B · Other: Product C · Other: Product D · Other: Product E · Other: Product F · Other: Product G
Experimental
Product usage order B A C G D F E
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
Other: Product A · Other: Product B · Other: Product C · Other: Product D · Other: Product E · Other: Product F · Other: Product G
Experimental
Product usage order C B D A E G F
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
Other: Product A · Other: Product B · Other: Product C · Other: Product D · Other: Product E · Other: Product F · Other: Product G
Experimental
Product usage order D C E B F A G
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
Other: Product A · Other: Product B · Other: Product C · Other: Product D · Other: Product E · Other: Product F · Other: Product G

Interventions

OtherProduct A
P1012915, a nicotine pouch with 8 mg nicotine
OtherProduct B
P1013018, a nicotine pouch with 10 mg nicotine
OtherProduct C
P1013015, a nicotine pouch with 8 mg nicotine
OtherProduct D
P1012815, a nicotine pouch with 8 mg nicotine
OtherProduct E
P1013315, a nicotine pouch with 8 mg nicotine
OtherProduct F
P1013115, a nicotine pouch with 8 mg nicotine
OtherProduct G
P1013215, a nicotine pouch with 8 mg nicotine

What researchers measure

Primary outcomes

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
Time frame: 0 to 240 minutes
Cmax
Maximum baseline-adjusted plasma concentration of nicotine
Time frame: 240 minutes

Study locations

1 site

AMR Knoxville
Knoxville, Tennessee 37920, United States

References and documents

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 ↗

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2021 to primary completion in Nov 2021, 1 month.

Of 155 interventional studies with no phase under Smoking, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 59. This study's 1 month is below that.

How these figures are worked out, and which studies are left out of them.

Registered: Oct 4, 2021
First posted: Oct 18, 2021
StartActual: Oct 20, 2021
Primary completionActual: Nov 24, 2021
CompletionActual: Nov 24, 2021
Last update: Jun 27, 2022

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jun 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05081154
Lead sponsor: RAI Services Company
Responsible party: Sponsor
First posted: Oct 18, 2021
Start date: Oct 20, 2021
Primary completion: Nov 24, 2021
Completion: Nov 24, 2021
Last update: Jun 27, 2022

Study contacts

Milly Kanobe, PhD

study director · RAIS

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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