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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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27 February 2024 |
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Main ID: |
ISRCTN14866695 |
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Date of registration:
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21/11/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A study investigating the uptake to the blood circulation and subjective effects of nicotine from tobacco free nicotine pods compared to tobacco based Swedish snus
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Scientific title:
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Nicotine pharmacokinetics and subjective effects of a single dose of a non-tobacco-based nicotine pouch (ZYN®) compared with conventional, tobacco-based Swedish snus among current, daily snus users |
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Date of first enrolment:
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16/11/2017 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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https://www.isrctn.com/ISRCTN14866695 |
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Study type:
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Interventional |
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Study design:
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Single-centre open randomized five-way cross over trial (Other)
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Phase:
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Not Applicable
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Mikael
Staaf |
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Address:
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Maria Skolgata 83
SE-118 53 Stockholm
Stockholm
Sweden |
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Snus user, with a minimum weekly consumption of three or more snus cans (brands with nicotine content <1%) or two or more cans (brands with nicotine content >1%) since =1 year
2. Consent to participate voluntarily and sign Informed Consent Form prior to any study procedure
3. Healthy male/female, age =19
4. Willing and able to comply with study procedures
5. A heart rate increase = 10 beats/min with first use of snus in the morning after overnight abstinence from any nicotine exposure
Exclusion criteria: 1. Smoker, defined as "smoking during the last 24 hours according to self-report and CO in exhaled air >10 ppm at clinical visits"
2. A history or presence of diagnosed hypertension or any cardiovascular disease
3. Surgery within 6 months of the screening visit that, in the opinion of the investigator, could negatively impact on the subject’s participation in the clinical study
4. Any surgical or medical condition, which, in the judgment of the clinical investigator, might interfere with the absorption, distribution, metabolism or excretion of the investigational product
5. 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
6. Pregnancy or planning to get pregnant during the study
7. Positive screen for drugs of abuse at screening or on admission to the unit prior to administration of the investigational product.
8. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV)
9. Current or history of alcohol abuse and/or use of anabolic steroids or drugs of abuse
10. Use of any prescribed or non-prescribed medication including antacids, analgesics and herbal remedies within two weeks prior to the first administration of IP, except occasional intake of paracetamol (maximum 2 000 mg/day; and not exceeding 3 000 mg/week), at the discretion of the Investigator
11. Plasma donation within 1 month of Screening or any blood donation/blood loss >450 mL during the 3 months prior to Screening
12. Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Tobacco use
Not Applicable
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Intervention(s)
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1. ZYN Smooth containing 3 mg nicotine per portion
2. ZYN Smooth containing 6 mg nicotine per portion
3. ZYN Smooth containing 3 mg nicotine per portion (alternative manufacturing process)
4. ZYN Smooth containing 6 mg nicotine per portion (alternative manufacturing process)
5. Swedish portion snus PSWL 1.0 g (8 mg nicotine/g)
The treatments are administered as single doses in a pre-determined computer-generated randomized order according to a four sequence list. The subject keeps the pouch still between the upper lip and the gum for 60 minutes. Serial plasma samples are drawn before, and at regular time intervals up to 6 hours after administration (10 samples). The duration of the treatments and follow-up for all study arms will be one day followed by 1-14 day(s) of wash-out (repeated for each dose time point) and follow-up seven days after the last dose.
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Primary Outcome(s)
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AUCinf based on plasma concentrations of nicotine after administration of one single dose of a novel, non-tobacco-based nicotine pouch containing 3 and 6 mg of nicotine, to that of one single dose from a 1 g Swedish snus pouch containing 8 mg of nicotine, is calculated based on measurement of nicotine in blood samples with a LC-MS/MS analytical method at the completion of the study
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Secondary Outcome(s)
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1. AUC60min, Cmax, Tmax, AUCo-t and terminal half-life of a novel, non-tobacco-based nicotine pouch to that of a Swedish snus pouch is calculated based on measurement of nicotine in blood samples with a LC-MS/MS analytical method at the completion of the study
2. In-vivo extracted amount of nicotine from each portion, measured by subtracting the residual amount after use from the mean of 10 unused portions at completion of the study
3. The correlation between the estimates of AUC(inf) and the total amount of nicotine extracted from the ZYN® pouches, measured by statistical evaluation of data
4. Pulse rate and ”head buzz” (head rush, ”hit”, feeling alert, overall ”product strength”) measured using a 100-mm visual analogue scale (VAS) anchored with ”not at all” to ”extremely” at preset time points up to 60 minutes (predose, + 5min, +10 min, + 15 min, +30 min, +60 min after each dose), respectively, after study product administration (proxy for systemic uptake)
5. Adverse events measured by patient interviews
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Source(s) of Monetary Support
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Swedish Match North Europe
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Ethics review
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Status:
Approval date:
Contact:
Old ethics approval format; EPN Uppsala, 01/11/2017, ref: Dnr 2017/433
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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15/01/2018 |
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URL:
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