Tobacco UseNCT04755348
A Study to Assess the Pharmacokinetics of Oral Nicotine Pouches and Lozenges in Healthy Adults
A study testing Product A, Product B and Product C in people with Tobacco Use and Tobacco Smoking, run by British American Tobacco (Investments) Limited at 1 site in United States.
Trial summary
This is a randomised, open-label, confined, cross-over study to evaluate the nicotine pharmacokinetics (PK) of modern oral nicotine pouches and nicotine lozenges carried out in 36 healthy adult subjects who smoke cigarettes and who may have experience using smokeless tobacco (loose or pouches). 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, Tobacco Smoking, Cigarette Smoking
- 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
- 18 Feb 2021to 25 Mar 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.
- Smoke manufactured combustible, filtered, non-menthol or menthol cigarettes, 83 mm to 100 mm in length as primary source of tobacco.
- Smokers who self-report use of a smokeless tobacco product (loose or pouch) prior to screening may also 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 an investigator.
- 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. If a subject reports use of a different UB cigarette at check in, that subject may continue provided they use that same UB cigarette throughout the study.
Show all 19Show fewer
- Expired breath carbon monoxide (ECO) level is ≥ 10 ppm and ≤ 100 ppm at screening.
- Positive urine cotinine test at screening.
- Willing to use the UB cigarette and nicotine pouch or lozenge IPs during the study period.
- Willing to abstain from tobacco and nicotine use for at least 12 hours prior to start of each of six test sessions.
- If female and of non-childbearing potential, must meet one of the following criteria:
- Surgically sterile (i.e., has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation/occlusion); or
- In a menopausal state (at least 1 year without menses), as confirmed by follicle stimulating hormone (FSH) levels (≥40 mIU/mL).
- If female and of childbearing potential, must agree to use one of the accepted contraceptive regimens from at least 30 days prior to the first administration of the IP during the study, and for at least 30 days after the last dose of the IP. An acceptable method of contraception includes one of the following:
- Abstinence from heterosexual intercourse;
- Hormonal contraceptives (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch);
- Intrauterine device (with or without hormones); or
- Use of a double barrier method (e.g., condom and spermicide) during the study and for at least 30 days after the last dose of the study medication.
- Agrees to an in-clinic confinement of 7 days (6 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 an investigator, 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 an investigator'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.
Show all 24Show fewer
- 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.
- Positive urine drug screen without evidence of a prescription or urine alcohol test at Day 1 (check-in), with the exception of for tetrahydrocannabinol (THC). If positive for THC, a cannabis intoxication evaluation will be performed at check-in, and inclusion will be at the discretion of an investigator.
- Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- Self reports use of the study IP (nicotine pouches or lozenges) currently or in the past.
- Recreationally uses vapor products (e.g., e-cigarettes, tank systems) more than one day per week, for the past 6 months prior to screening.
- Current, regular user (i.e., > 5 times per month) of any tobacco products other than combustible cigarettes or smokeless tobacco within the last 6 months prior to screening.
- Use of any medication or substance that aids in smoking cessation, including but not limited to any nicotine replacement therapy (NRT) (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 attempt within (≤) 30 days prior to the signing the informed consent.
- Any use of aspirin (≥ 325 mg/day) or anticoagulants within (≤) 30 days prior to the signing of informed consent.
- 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 the signing of 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 the signing of 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 of informed consent in the current study.
- Drinks more than 21 servings of alcoholic beverages per week or has a positive alcohol result at screening or check-in Day 1.
- Determined by an investigator to be inappropriate for this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Altasciences Clinical Kansas, Inc.
Overland Park, Kansas, 66212
About this study
Official title: A Single Dose, Randomised, Crossover Study to Assess the Pharmacokinetics of Oral Nicotine Pouches and Lozenges in Healthy Adults
This is a randomised, open-label, confined, cross-over study to evaluate the nicotine pharmacokinetics (PK) of modern oral nicotine pouches and nicotine lozenges carried out in 36 healthy adult subjects who smoke cigarettes and who may have experience using smokeless tobacco (loose or pouches).
Read the detailed description
Starting on Day 1, subjects will check-in at the clinical site to complete procedures to confirm eligibility. Following basic check-in procedures (e.g., urine pregnancy test, urine drug screen, alcohol test and vital signs), subjects will continue with a 7-day confinement. Subjects will be randomized to a product sequence (using a Williams design).
Test sessions will occur every day during the remainder of the study. The active period of each test session will last for approximately 4 hours after the start of Investigational Product (IP) use. During each test session, a subject will be required to use their randomized IP and during the session, PK blood draws and a subjective effects questionnaire will be collected.
The day prior to each test session, subjects will participate in a product familiarization period in which they will use one pouch or lozenge of their randomized IP. The product familiarization period will occur after the scheduled test session (or after enrollment and randomization on Day 1) and before the 12-hour tobacco and nicotine abstinence period. Subjects should use the IP pouch for at least 30 minutes or allow the lozenge to dissolve slowly.
Subjects will provide usual brand (UB) cigarettes for use during study confinement and have access to their UB cigarettes for ad libitum use with the exception of 1) during the test session, 2) during the the minimum 12-hour tobacco and nicotine abstinence period prior to each test session and 3) a minimum of one hour after IP use during the product familiarization period. Each UB cigarette must be requested from site staff and used butts returned to site staff for accountability.
- Conditions
- Tobacco Use, Tobacco Smoking, Cigarette Smoking
- Being tested
- Product A, Product B, Product C, Product D, Product E
- Medical subject headings
- Tobacco Use, Tobacco Smoking, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Product AOther
A 4mg nicotine pouch product
Product BOther
A 4mg nicotine pouch product
Product COther
A 2mg nicotine lozenge product
Product DOther
A 2mg nicotine lozenge product
Product EOther
A 2mg nicotine lozenge product
Product FOther
A 2mg nicotine lozenge product
| Study group | Role | What they receive |
|---|---|---|
| Product usage order ABFCED | Experimental | Subjects will use each of the 6 products (ABFCED) during an familiarization 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 |
| Product usage order BCADFE | Experimental | Subjects will use each of the 6 products (ABECD) during an familiarization 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 |
| Product usage order CDBEAF | Experimental | Subjects will use each of the 6 products (CDBEAF) during an familiarization 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 |
| Product usage order DECFBA | Experimental | Subjects will use each of the 6 products (DECFBA) during an familiarization 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 |
| Product usage order EFDACB | Experimental | Subjects will use each of the 6 products (EFDACB) during an familiarization 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 |
| Product usage order FAEBDC | Experimental | Subjects will use each of the 6 products (FAEBDC) during an familiarization 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum baseline-adjusted plasma concentration of nicotine
Measured: 240 minutes
AUC0-240 mins
Baseline-adjusted area under the plasma nicotine concentration-versus-time curve from time zero to 240 minutes after the start of IP use
Measured: 0-240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start18 Feb 2021
- Primary completion20 Mar 2021
- Study completion25 Mar 2021
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.
- 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
- British American Tobacco (Investments) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Debra Kelsh, MD, Principal investigator, Altasciences Company Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755348
- Sponsor's protocol ID
- BAT2221030
- Status last verified
- Mar 2021
- First submitted
- 11 Feb 2021
- Last updated
- 30 Mar 2021
- 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 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose, Randomised, Crossover Study to Assess the Pharmacokinetics of Oral Nicotine Pouches and Lozenges in Healthy Adults
- ClinicalTrials.gov ID
- NCT04755348
- Acronym / sponsor ID
- BAT2221030
- Conditions
- Tobacco Use, Tobacco Smoking, Cigarette Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- British American Tobacco (Investments) LimitedIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 20 Mar 2021 (actual)
- Study completion
- 25 Mar 2021 (actual)
- First posted
- 16 Feb 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 is a randomised, open-label, confined, cross-over study to evaluate the nicotine pharmacokinetics (PK) of modern oral nicotine pouches and nicotine lozenges carried out in 36 healthy adult subjects who smoke cigarettes and who may have experience using smokeless tobacco (loose or pouches).
Detailed description
Starting on Day 1, subjects will check-in at the clinical site to complete procedures to confirm eligibility. Following basic check-in procedures (e.g., urine pregnancy test, urine drug screen, alcohol test and vital signs), subjects will continue with a 7-day confinement. Subjects will be randomized to a product sequence (using a Williams design).
Test sessions will occur every day during the remainder of the study. The active period of each test session will last for approximately 4 hours after the start of Investigational Product (IP) use. During each test session, a subject will be required to use their randomized IP and during the session, PK blood draws and a subjective effects questionnaire will be collected.
The day prior to each test session, subjects will participate in a product familiarization period in which they will use one pouch or lozenge of their randomized IP. The product familiarization period will occur after the scheduled test session (or after enrollment and randomization on Day 1) and before the 12-hour tobacco and nicotine abstinence period. Subjects should use the IP pouch for at least 30 minutes or allow the lozenge to dissolve slowly.
Subjects will provide usual brand (UB) cigarettes for use during study confinement and have access to their UB cigarettes for ad libitum use with the exception of 1) during the test session, 2) during the the minimum 12-hour tobacco and nicotine abstinence period prior to each test session and 3) a minimum of one hour after IP use during the product familiarization period. Each UB cigarette must be requested from site staff and used butts returned to site staff for accountability.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Product usage order ABFCED | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product FSubjects will use each of the 6 products (ABFCED) during an familiarization period, followed by a 4 hour Test Session |
| Product usage order BCADFE | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product FSubjects will use each of the 6 products (ABECD) during an familiarization period, followed by a 4 hour Test Session |
| Product usage order CDBEAF | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product FSubjects will use each of the 6 products (CDBEAF) during an familiarization period, followed by a 4 hour Test Session |
| Product usage order DECFBA | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product FSubjects will use each of the 6 products (DECFBA) during an familiarization period, followed by a 4 hour Test Session |
| Product usage order EFDACB | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product FSubjects will use each of the 6 products (EFDACB) during an familiarization period, followed by a 4 hour Test Session |
| Product usage order FAEBDC | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product D, Other: Product E, Other: Product FSubjects will use each of the 6 products (FAEBDC) during an familiarization 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 (19 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.
- Smoke manufactured combustible, filtered, non-menthol or menthol cigarettes, 83 mm to 100 mm in length as primary source of tobacco.
- Smokers who self-report use of a smokeless tobacco product (loose or pouch) prior to screening may also 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 an investigator.
Key exclusion criteria (24 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 an investigator, 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 an investigator'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 AA 4mg nicotine pouch product | Other | Product usage order ABFCED, Product usage order BCADFE, Product usage order CDBEAF, Product usage order DECFBA, Product usage order EFDACB, Product usage order FAEBDC |
| Product BA 4mg nicotine pouch product | Other | Product usage order ABFCED, Product usage order BCADFE, Product usage order CDBEAF, Product usage order DECFBA, Product usage order EFDACB, Product usage order FAEBDC |
| Product CA 2mg nicotine lozenge product | Other | Product usage order ABFCED, Product usage order BCADFE, Product usage order CDBEAF, Product usage order DECFBA, Product usage order EFDACB, Product usage order FAEBDC |
| Product DA 2mg nicotine lozenge product | Other | Product usage order ABFCED, Product usage order BCADFE, Product usage order CDBEAF, Product usage order DECFBA, Product usage order EFDACB, Product usage order FAEBDC |
| Product EA 2mg nicotine lozenge product | Other | Product usage order ABFCED, Product usage order BCADFE, Product usage order CDBEAF, Product usage order DECFBA, Product usage order EFDACB, Product usage order FAEBDC |
| Product FA 2mg nicotine lozenge product | Other | Product usage order ABFCED, Product usage order BCADFE, Product usage order CDBEAF, Product usage order DECFBA, Product usage order EFDACB, Product usage order FAEBDC |
Primary outcome
Cmax
Time frame: 240 minutes
Maximum baseline-adjusted plasma concentration of nicotine
AUC0-240 mins
Time frame: 0-240 minutes
Baseline-adjusted area under the plasma nicotine concentration-versus-time curve from time zero to 240 minutes after the start of IP use
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 30 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Tobacco Use
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Active, not recruiting
Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users
Tobacco Smoking, Vaping
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
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.
Debra Kelsh, MD principal investigator
Altasciences Company Inc.
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 Tobacco Use and Tobacco Smoking, run by British American Tobacco (Investments) Limited 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 19 inclusion and 24 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 30 Mar 2021. 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?
Cmax (time frame: 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?
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 30 Mar 2021.