Nicotine Use DisorderNCT06170138
Study to Assess PK, PD, Nicotine Extraction, Palatability, Subjective Effects of Nicotine Pouches - Daily Nicotine Users
A study testing Test product 1 - Test product 2 - Comparator product in people with Nicotine Use Disorder, run by Amplicon AB at 1 site in Sweden.
Trial summary
This is an explorative, open-label, randomised, 3-way cross-over study to assess pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability, nicotine extraction, palatability and subjective effects after single use of nicotine pouches in daily nicotine users. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Use Disorder
- What is being tested?
- Test product 1 - Test product 2 - Comparator product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSweden
- Study dates
- 24 Nov 2023to Mar 2024
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing and able to give written informed consent for participation in the study.
- Subjects who have used oral tobacco/nicotine products for ≥1 year, with a minimum daily consumption of 5 or more pouches with a pouch strength of 3-9 mg nicotine/pouch. Concomitant occasional use of other nicotine products (e.g., smoking, vaping) is allowed, as judged by the Investigator at the time of the screening visit.
- Healthy male or female subject aged 25 to 55 years, inclusive, at the time of the screening visit.
- Female subjects of childbearing potential must be willing to use a sufficient contraceptive method for the duration of the study, this includes mechanical barrier (e.g., a male condom or a female diaphragm), combined [oestrogen and progestogen containing] hormonal contraception associated with inhibition of ovulation [oral, intravaginal, transdermal], progestogen-only hormonal anticonception associated with inhibition of ovulation [oral, injectable, implantable], intra uterine device (IUD) or intra uterine system (IUS). Sexual abstinence is allowed when this is the preferred and usual lifestyle of the subject.
- Body Mass Index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 and a minimum weight of ≥ 50 kg.
- Medically healthy subject without abnormal clinically significant medical history, physical findings, vital signs, ECG and laboratory values at the time of the screening visit, as judged by the Investigator.
- Positive urine cotinine test (≥200 ng/mL) at the screening visit.
Who cannot join
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- After 10 minutes supine rest at the screening visit, any vital signs values outside the following ranges: - Systolic blood pressure: <90 or >140 mmHg, or - Diastolic blood pressure <50 or >90 mmHg, or - Pulse <40 or >90 bpm
- Any surgical or medical condition, including abnormal salivation (also pharmaceutically induced), or history thereof, which, in the judgment of the Investigator, might interfere with the absorption, distribution, metabolism or excretion of the IP or may either put the subject at risk because of participation in the study, influence the results, or the subject's ability to participate in the study.
- A history of diagnosed severe allergy/hypersensitivity or ongoing manifestations of severe allergy/hypersensitivity to aroma compounds (including fragrances and/or flavourings), as judged by the Investigator.
- Any planned major surgery within the duration of the study.
- Subjects who are pregnant, currently breastfeeding, or intend to become pregnant during the course of the study.
Show all 16Show fewer
- Any positive result at the screening visit for serum hepatitis B surface antigen, hepatitis C antibodies and/or HIV.
- Positive screening result for drugs of abuse or alcohol at the screening visit or on admission to the study site prior to IP use at Visits 2 to 4. (Positive results that are expected given the subject's medical history and prescribed medications can be disregarded as judged by the Investigator.)
- Presence or history of drug abuse, as judged by the Investigator.
- History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator.
- History of, or current use of anabolic steroids, as judged by the Investigator.
- Current, ongoing use of beta-adrenergic blocking agents (beta blockers), including pro re nata (as needed) use.
- Current, ongoing use of any medication known to be able to interfere with adrenaline testing, including but not limited to central nervous system stimulants (amphetamines), also including pro re nata (as needed) use, as judged by the Investigator.
- Plasma donation within 1 month of the screening visit or blood donation (or corresponding blood loss) during the last 3 months prior to the screening visit.
- Subjects who intend to change their nicotine consumption habit, including the intention to stop using nicotine products, within the next 3 months from the screening visit, as judged by the Investigator.
- The Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Clinical Trial Consultants AB (CTC)
Uppsala, SE-752 37
Erik Rein-Hedin, MD, +46 (0)70 755 20 89, erik.rein-hedin@ctc-ab.se
About this study
Official title: An Explorative, Open-label, Randomised, 3-way Cross-over Study to Assess the Pharmacokinetics, Pharmacodynamics, Nicotine Extraction, Palatability, and Subjective Effects After Single Use of Nicotine Pouches in Daily Nicotine Users.
This is an explorative, open-label, randomised, 3-way cross-over study to assess pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability, nicotine extraction, palatability and subjective effects after single use of nicotine pouches in daily nicotine users.
Read the detailed description
This is an explorative, open-label, randomised, 3-way cross-over, single use study, designed to assess the nicotine exposure from new nicotine pouch products.
A cross-over design was chosen to yield a more efficient comparison of the IPs than a parallel study design, i.e., fewer subjects are required since each subject will serve as its own control. To avoid carryover effects, subjects will abstain from oral tobacco/nicotine products as well as smoking (cigarettes or e-cigarettes) for at least 12 hours prior to each IP use (Visit 2-4).
Randomisation will be used to minimise bias in the assignment of subjects to an IP administration sequence and to increase the likelihood that known and unknown subject attributes (e.g., demographic and baseline characteristics) are evenly balanced.
The main purpose of this study is to understand the PK as well as to analyse the nicotine content left in pouch after use of Ampli01 and compare with a reference product. This will give consumers a better understanding of the behaviour of the product with the aim to be a potential satisfactory alternative to cigarette smoking. In addition, the safety profile, PD and subjective effects will be investigated and evaluated.
In summary, this study will provide critical data to assess PK, safety and formulation optimization to be able to provide consumers with a high-quality product. In addition, this study will contribute to the overall knowledge about nicotine pouches that can be of scientific value to improve public health strategies and regulations.
The study will include 12 randomised and evaluable subjects. The subjects are healthy male or female oral tobacco/nicotine pouch users aged 25 to 55 years, inclusive, who have used oral tobacco/nicotine products for ≥1 year, with a minimum daily consumption of 5 or more pouches (pouch strength 3-9 mg/pouch). Each subject will participate in the study for up to approximately 6 weeks, including the up to 28-day screening period.
- Conditions
- Nicotine Use Disorder
- Being tested
- Test product 1 - Test product 2 - Comparator product
- Keywords
- nicotine, nicotine pouch products
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test product 1 - Test product 2 - Comparator productOther
Each subject will be randomised to 1 of 6 IP use sequences The IPs will be administered as single pouches in a pre-determined randomised order.
Test product 1 - Ampli-01 3 mg, nicotine pouch Test product 2 - Ampli-01 6 mg, nicotine pouch Comparator product - ZYN Cool Mint Mini Dry 6 mg nicotine /pouch Single 30-minutes IP use on 3 occasions (Visits 2 to 4).
| Study group | Role | What they receive |
|---|---|---|
| Ampli-01, 3 mg, nicotine pouch | Experimental | Subjects will report to the study site for a screening visit followed by 3 visits with a single IP use (Visits 2 to 4) on separate days.There will be at least 1 day between Visits 2, 3 and 4, respectively, where the subjects are allowed ad libitum use of their own nicotine product of choice. Each visit will last one day. Receives: Other: Test product 1 - Test product 2 - Comparator product |
| Ampli-01, 6 mg, nicotine pouch | Experimental | Subjects will report to the study site for a screening visit followed by 3 visits with a single IP use (Visits 2 to 4) on separate days.There will be at least 1 day between Visits 2, 3 and 4, respectively, where the subjects are allowed ad libitum use of their own nicotine product of choice. Each visit will last one day. Receives: Other: Test product 1 - Test product 2 - Comparator product |
| ZYN Cool Mint Mini Dry, 6 mg nicotine /pouch | Active comparator | Subjects will report to the study site for a screening visit followed by 3 visits with a single IP use (Visits 2 to 4) on separate days.There will be at least 1 day between Visits 2, 3 and 4, respectively, where the subjects are allowed ad libitum use of their own nicotine product of choice. Each visit will last one day. Receives: Other: Test product 1 - Test product 2 - Comparator product |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC from timepoint 0 to infinity (AUCinf),
Non-adjusted and baseline-adjusted PK parameters for nicotine including area under the curve (AUC) from timepoint 0 to infinity (AUCinf).
Measured: Visit 2-4 (1 visit = 1 day): Pre-use and at 5, 10, 15, 20, 30, 40, 50, 60 minutes, 1 hour and 30 minutes, 2, 4, 6 and 8 hours post-IP use on visit 2, 3 and 4.
AUC from timepoint 0 to timepoint t (AUC0-t)
Non-adjusted and baseline-adjusted PK parameters for nicotine including AUC from timepoint 0 to timepoint t (AUC0-t).
Measured: Visit 2-4 (1 visit = 1 day): Pre-use and at 5, 10, 15, 20, 30, 40, 50, 60 minutes, 1 hour and 30 minutes, 2, 4, 6 and 8 hours post-IP use on visit 2, 3 and 4.
AUC from timepoint 0 to 30 minutes (AUC0-30min)
Non-adjusted and baseline-adjusted PK parameters for nicotine including AUC from timepoint 0 to 30 minutes (AUC0-30min).
Measured: Visit 2-4 (1 visit = 1 day): Pre-use and at 5, 10, 15, 20, 30, 40, 50, 60 minutes, 1 hour and 30 minutes, 2, 4, 6 and 8 hours post-IP use on visit 2, 3 and 4.
AUC from timepoint 0 to 60 minutes (AUC0-60min)
Non-adjusted and baseline-adjusted PK parameters for nicotine including AUC from timepoint 0 to 60 minutes (AUC0-60min).
Measured: Visit 2-4 (1 visit = 1 day): Pre-use and at 5, 10, 15, 20, 30, 40, 50, 60 minutes, 1 hour and 30 minutes, 2, 4, 6 and 8 hours post-IP use on visit 2, 3 and 4.
Maximum plasma concentration (Cmax)
Non-adjusted and baseline-adjusted PK parameters for nicotine including maximum plasma concentration (Cmax).
Measured: Visit 2-4 (1 visit = 1 day): Pre-use and at 5, 10, 15, 20, 30, 40, 50, 60 minutes, 1 hour and 30 minutes, 2, 4, 6 and 8 hours post-IP use on visit 2, 3 and 4.
Time to Cmax (Tmax)
Non-adjusted and baseline-adjusted PK parameters for nicotine including time to Cmax (Tmax).
Measured: Visit 2-4 (1 visit = 1 day): Pre-use and at 5, 10, 15, 20, 30, 40, 50, 60 minutes, 1 hour and 30 minutes, 2, 4, 6 and 8 hours post-IP use on visit 2, 3 and 4.
Terminal elimination half-life (T1/2)
Non-adjusted and baseline-adjusted PK parameters for nicotine including terminal elimination half-life (T1/2).
Measured: Visit 2-4 (1 visit = 1 day): Pre-use and at 5, 10, 15, 20, 30, 40, 50, 60 minutes, 1 hour and 30 minutes, 2, 4, 6 and 8 hours post-IP use on visit 2, 3 and 4.
Secondary outcomes (6)
In vivo extracted amount (mg/unit) of nicotine
In vivo extracted amount (mg/unit) of nicotine, for each investigational product (IP).
Measured: Visit 2-4 (1 visit = 1 day).
In vivo extracted fraction (%) of nicotine
In vivo extracted fraction (%) of nicotine, for each investigational product (IP).
Measured: Visit 2-4 (1 visit = 1 day).
Highest recorded increase (Emax) in pulse rate from baseline.
Highest recorded increase (Emax) in pulse rate from baseline. Change from baseline.
Measured: Visit 2-4 (1 visit = 1 day): Pre-use and at 5, 10, 15, 20, 30, 40, 50, 60 minutes, 1 hour and 30 minutes, 2, 4, 6 and 8 hours post-IP use on visit 2, 3 and 4.
Mean score for each palatability question 30 minutes after start of IP use.
Mean score for each palatability question 30 minutes after start of IP use.
Measured: Visit 2-4 (1 visit = 1 day): 30 minutes post-IP use on visit 2, 3 and 4.
Urge-to-use
Urge-to-use, product-liking, intent-to-use-again and onset-of-effect 30 minutes after start of IP use. Change from baseline for urge-to-use 30 minutes, 1 hour and 2 hours after start of IP use.
Measured: Visit 2-4 (1 visit = 1 day) : Pre-use and at 30, 60 minutes and 2 hours, post-IP use on visit 2, 3 and 4.
Adverse events (AEs).
Frequency, seriousness and intensity of adverse events (AEs).
Measured: Visit 2-4:All AEs (including SAEs) will be collected from the start of the first IP use until the last visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start24 Nov 2023
- Primary completion14 Dec 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine Use DisorderStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each subject will be randomised to 1 of 6 IP use sequences The IPs will be administered as single pouches in a pre-determined randomised order. Test product 1 - Ampli-01 3 mg, nicotine pouch Test product 2 - Ampli-01 6 mg, nicotine pouch Comparator product - ZYN Cool Mint Mini Dry 6 mg nicotine /pouch Single 30-minutes IP use on 3 occasions (Visits 2 to 4).
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amplicon AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erik Rein-Hedin, MD, Principal investigator, Clinical Trial Consultants AB (CTC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170138
- Sponsor's protocol ID
- AMP-01-101
- Status last verified
- Dec 2023
- First submitted
- 23 Nov 2023
- Last updated
- 14 Dec 2023
- 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 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Explorative, Open-label, Randomised, 3-way Cross-over Study to Assess the Pharmacokinetics, Pharmacodynamics, Nicotine Extraction, Palatability, and Subjective Effects After Single Use of Nicotine Pouches in Daily Nicotine Users.
- ClinicalTrials.gov ID
- NCT06170138
- Acronym / sponsor ID
- AMP-01-101
- Conditions
- Nicotine Use Disorder
- Keywords
- nicotine, nicotine pouch products
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Amplicon ABIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2023 (actual)
- Primary completion
- 14 Dec 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 14 Dec 2023 (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 an explorative, open-label, randomised, 3-way cross-over study to assess pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability, nicotine extraction, palatability and subjective effects after single use of nicotine pouches in daily nicotine users.
Detailed description
This is an explorative, open-label, randomised, 3-way cross-over, single use study, designed to assess the nicotine exposure from new nicotine pouch products.
A cross-over design was chosen to yield a more efficient comparison of the IPs than a parallel study design, i.e., fewer subjects are required since each subject will serve as its own control. To avoid carryover effects, subjects will abstain from oral tobacco/nicotine products as well as smoking (cigarettes or e-cigarettes) for at least 12 hours prior to each IP use (Visit 2-4).
Randomisation will be used to minimise bias in the assignment of subjects to an IP administration sequence and to increase the likelihood that known and unknown subject attributes (e.g., demographic and baseline characteristics) are evenly balanced.
The main purpose of this study is to understand the PK as well as to analyse the nicotine content left in pouch after use of Ampli01 and compare with a reference product. This will give consumers a better understanding of the behaviour of the product with the aim to be a potential satisfactory alternative to cigarette smoking. In addition, the safety profile, PD and subjective effects will be investigated and evaluated.
In summary, this study will provide critical data to assess PK, safety and formulation optimization to be able to provide consumers with a high-quality product. In addition, this study will contribute to the overall knowledge about nicotine pouches that can be of scientific value to improve public health strategies and regulations.
The study will include 12 randomised and evaluable subjects. The subjects are healthy male or female oral tobacco/nicotine pouch users aged 25 to 55 years, inclusive, who have used oral tobacco/nicotine products for ≥1 year, with a minimum daily consumption of 5 or more pouches (pouch strength 3-9 mg/pouch). Each subject will participate in the study for up to approximately 6 weeks, including the up to 28-day screening period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Each subject will be randomised to 1 of 6 IP use sequences The IPs will be administered as single pouches in a pre-determined randomised order. Test product 1 - Ampli-01 3 mg, nicotine pouch Test product 2 - Ampli-01 6 mg, nicotine pouch Comparator product - ZYN Cool Mint Mini Dry 6 mg nicotine /pouch Single 30-minutes IP use on 3 occasions (Visits 2 to 4).
| Arm | Type | Receives |
|---|---|---|
| Ampli-01, 3 mg, nicotine pouch | Experimental | Other: Test product 1 - Test product 2 - Comparator productSubjects will report to the study site for a screening visit followed by 3 visits with a single IP use (Visits 2 to 4) on separate days.There will be at least 1 day between Visits 2, 3 and 4, respectively, where the subjects are allowed ad libitum use of their own nicotine product of choice. Each visit will last one day. |
| Ampli-01, 6 mg, nicotine pouch | Experimental | Other: Test product 1 - Test product 2 - Comparator productSubjects will report to the study site for a screening visit followed by 3 visits with a single IP use (Visits 2 to 4) on separate days.There will be at least 1 day between Visits 2, 3 and 4, respectively, where the subjects are allowed ad libitum use of their own nicotine product of choice. Each visit will last one day. |
| ZYN Cool Mint Mini Dry, 6 mg nicotine /pouch | Active comparator | Other: Test product 1 - Test product 2 - Comparator productSubjects will report to the study site for a screening visit followed by 3 visits with a single IP use (Visits 2 to 4) on separate days.There will be at least 1 day between Visits 2, 3 and 4, respectively, where the subjects are allowed ad libitum use of their own nicotine product of choice. Each visit will last one day. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Willing and able to give written informed consent for participation in the study.
- Subjects who have used oral tobacco/nicotine products for ≥1 year, with a minimum daily consumption of 5 or more pouches with a pouch strength of 3-9 mg nicotine/pouch. Concomitant occasional use of other nicotine products (e.g., smoking, vaping) is allowed, as judged by the Investigator at the time of the screening visit.
- Healthy male or female subject aged 25 to 55 years, inclusive, at the time of the screening visit.
- Female subjects of childbearing potential must be willing to use a sufficient contraceptive method for the duration of the study, this includes mechanical barrier (e.g., a male condom or a female diaphragm), combined [oestrogen and progestogen containing] hormonal contraception associated with inhibition of ovulation [oral, intravaginal, transdermal], progestogen-only hormonal anticonception associated with inhibition of ovulation [oral, injectable, implantable], intra uterine device (IUD) or intra uterine system (IUS). Sexual abstinence is allowed when this is the preferred and usual lifestyle of the subject.
- Body Mass Index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 and a minimum weight of ≥ 50 kg.
Key exclusion criteria (16 listed)
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- After 10 minutes supine rest at the screening visit, any vital signs values outside the following ranges: - Systolic blood pressure: <90 or >140 mmHg, or - Diastolic blood pressure <50 or >90 mmHg, or - Pulse <40 or >90 bpm
- Any surgical or medical condition, including abnormal salivation (also pharmaceutically induced), or history thereof, which, in the judgment of the Investigator, might interfere with the absorption, distribution, metabolism or excretion of the IP or may either put the subject at risk because of participation in the study, influence the results, or the subject's ability to participate in the study.
- A history of diagnosed severe allergy/hypersensitivity or ongoing manifestations of severe allergy/hypersensitivity to aroma compounds (including fragrances and/or flavourings), as judged by the Investigator.
- Any planned major surgery within the duration of the study.
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 |
|---|---|---|
| Test product 1 - Test product 2 - Comparator productEach subject will be randomised to 1 of 6 IP use sequences The IPs will be administered as single pouches in a pre-determined randomised order. Test product 1 - Ampli-01 3 mg, nicotine pouch Test product 2 - Ampli-01 6 mg, nicotine pouch Comparator product - ZYN Cool Mint Mini Dry 6 mg nicotine /pouch Single 30-minutes IP use on 3 occasions (Visits 2 to 4). | Other | Ampli-01, 3 mg, nicotine pouch, Ampli-01, 6 mg, nicotine pouch, ZYN Cool Mint Mini Dry, 6 mg nicotine /pouch |
Primary outcome
AUC from timepoint 0 to infinity (AUCinf),
Time frame: Visit 2-4 (1 visit = 1 day): Pre-use and at 5, 10, 15, 20, 30, 40, 50, 60 minutes, 1 hour and 30 minutes, 2, 4, 6 and 8 hours post-IP use on visit 2, 3 and 4.
Non-adjusted and baseline-adjusted PK parameters for nicotine including area under the curve (AUC) from timepoint 0 to infinity (AUCinf).
AUC from timepoint 0 to timepoint t (AUC0-t)
Time frame: Visit 2-4 (1 visit = 1 day): Pre-use and at 5, 10, 15, 20, 30, 40, 50, 60 minutes, 1 hour and 30 minutes, 2, 4, 6 and 8 hours post-IP use on visit 2, 3 and 4.
Non-adjusted and baseline-adjusted PK parameters for nicotine including AUC from timepoint 0 to timepoint t (AUC0-t).
AUC from timepoint 0 to 30 minutes (AUC0-30min)
Time frame: Visit 2-4 (1 visit = 1 day): Pre-use and at 5, 10, 15, 20, 30, 40, 50, 60 minutes, 1 hour and 30 minutes, 2, 4, 6 and 8 hours post-IP use on visit 2, 3 and 4.
Non-adjusted and baseline-adjusted PK parameters for nicotine including AUC from timepoint 0 to 30 minutes (AUC0-30min).
AUC from timepoint 0 to 60 minutes (AUC0-60min)
Time frame: Visit 2-4 (1 visit = 1 day): Pre-use and at 5, 10, 15, 20, 30, 40, 50, 60 minutes, 1 hour and 30 minutes, 2, 4, 6 and 8 hours post-IP use on visit 2, 3 and 4.
Non-adjusted and baseline-adjusted PK parameters for nicotine including AUC from timepoint 0 to 60 minutes (AUC0-60min).
Maximum plasma concentration (Cmax)
Time frame: Visit 2-4 (1 visit = 1 day): Pre-use and at 5, 10, 15, 20, 30, 40, 50, 60 minutes, 1 hour and 30 minutes, 2, 4, 6 and 8 hours post-IP use on visit 2, 3 and 4.
Non-adjusted and baseline-adjusted PK parameters for nicotine including maximum plasma concentration (Cmax).
Time to Cmax (Tmax)
Time frame: Visit 2-4 (1 visit = 1 day): Pre-use and at 5, 10, 15, 20, 30, 40, 50, 60 minutes, 1 hour and 30 minutes, 2, 4, 6 and 8 hours post-IP use on visit 2, 3 and 4.
Non-adjusted and baseline-adjusted PK parameters for nicotine including time to Cmax (Tmax).
Terminal elimination half-life (T1/2)
Time frame: Visit 2-4 (1 visit = 1 day): Pre-use and at 5, 10, 15, 20, 30, 40, 50, 60 minutes, 1 hour and 30 minutes, 2, 4, 6 and 8 hours post-IP use on visit 2, 3 and 4.
Non-adjusted and baseline-adjusted PK parameters for nicotine including terminal elimination half-life (T1/2).
6 secondary outcomes
In vivo extracted amount (mg/unit) of nicotine
Time frame: Visit 2-4 (1 visit = 1 day).
In vivo extracted fraction (%) of nicotine
Time frame: Visit 2-4 (1 visit = 1 day).
Highest recorded increase (Emax) in pulse rate from baseline.
Time frame: Visit 2-4 (1 visit = 1 day): Pre-use and at 5, 10, 15, 20, 30, 40, 50, 60 minutes, 1 hour and 30 minutes, 2, 4, 6 and 8 hours post-IP use on visit 2, 3 and 4.
Mean score for each palatability question 30 minutes after start of IP use.
Time frame: Visit 2-4 (1 visit = 1 day): 30 minutes post-IP use on visit 2, 3 and 4.
Urge-to-use
Time frame: Visit 2-4 (1 visit = 1 day) : Pre-use and at 30, 60 minutes and 2 hours, post-IP use on visit 2, 3 and 4.
Adverse events (AEs).
Time frame: Visit 2-4:All AEs (including SAEs) will be collected from the start of the first IP use until the last visit.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Nicotine Use Disorder
Recruiting
MATAspire: Mental Health Awareness Tailored App for Substance Prevention and Integrated Resilience Education
Alcohol Use, Cannabis Use
Recruiting
Circuit Breathing Exercise on Smoking Cessation Among Youth E-Cigarette Users
E Cigarette Use
Recruiting
Use of Nicotine Pouches Among Daily Smokers
Tobacco Dependence
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
Not yet recruiting
Quit With Sense: Using Mindful Smoking and Wearable Device for Smoking Cessation
Smoking Cessation, Cigarette Smoking
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.
Erik Rein-Hedin, MD principal investigator
Clinical Trial Consultants AB (CTC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test product 1 - Test product 2 - Comparator product in people with Nicotine Use Disorder, run by Amplicon AB at 1 site in Sweden.
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 7 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 14 Dec 2023. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Franzén, PhD (+46 (0)72 890 67 77, anna.franzen@emplicure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC from timepoint 0 to infinity (AUCinf), (time frame: Visit 2-4 (1 visit = 1 day): Pre-use and at 5, 10, 15, 20, 30, 40, 50, 60 minutes, 1 hour and 30 minutes, 2, 4, 6 and 8 hours post-IP use on visit 2, 3 and 4.). The study lists 7 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 14 Dec 2023.