Smoking CessationPhase 1SMWS03NCT01838473
In-vivo Extraction of Lead, Cadmium and Tobacco Specific Nitrosamines From Swedish 'Snus' in Regular Snus Users
A Phase 1 study testing Buccal Administration of nicotine in people with Smoking Cessation and Harm Reduction, run by Contract Research Organization el AB at 1 site in Sweden.
Trial summary
In an open label, randomized, two-way cross-over study, 32 male healthy regular snus users will be given repeated doses of four different types of portion snus: "General", "Catch", "Catch Mini" and "Catch Dry Mini". Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Harm Reduction
- What is being tested?
- Buccal Administration of nicotine
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSweden
- Study dates
- May 2004to Apr 2005
- Phase
- Phase 1
- 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 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- non-smokers, 18 to 50 years of age.
- Habitual use of > 7 portions snus daily since minimum 1 year.
- Healthy according to the health declaration and interview.
- Written informed consent given.
Who cannot join
- Concurrent participation in another clinical trial.
- History of allergy.
- History of allergy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In-vivo Extraction of Lead, Cadmium and Tobacco Specific Nitrosamines From Four Brands of Swedish 'Snus' in Regular Snus Users.
In an open label, randomized, two-way cross-over study, 32 male healthy regular snus users will be given repeated doses of four different types of portion snus: "General", "Catch", "Catch Mini" and "Catch Dry Mini". Each portion of used snus will be collected and frozen (-20 oC) pending analysis of lead (Pb), cadmium (Cd), nicotine and tobacco specific nitrosamines (TSNAs). Unused snus is collected and deep frozen for analysis and calculation of extracted dose. Calculations of extracted amount of lead, cadmium, nicotine and tobacco specific nitrosamines (TSNAs) respectively, will be done for each type of snus.
Read the detailed description
Comparisons:
A= "General Portion" 1 g portion snus containing approximately 8 mg nicotine per portion.
B= "Catch Licorice Portion" 1 g portion snus containing approximately 8 mg nicotine per portion.
C= "Catch Licorice Portion Mini" 0.5 g portion snus containing approximately 4 mg nicotine per portion.
D= "Catch Dry Licorice Portion Mini" 0.3 g portion snus containing approximately 4 mg nicotine per portion.
Swedish portion snus will be administered once every hour (4 administrations/brand) and will be kept between the upper lip and the gum for 30 minutes. Preload of own brand each morning.
- Conditions
- Smoking Cessation, Harm Reduction
- Being tested
- Buccal Administration of nicotine
- Keywords
- smokeless tobacco, Nicotine, Cadmium, lead, Tobacco Specific Nitrosamines
- Medical subject headings
- Smoking Cessation, Harm Reduction, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buccal Administration of nicotineProcedure or surgery
Also called Smokeless tobacco, ST, Potential Exposure Reduced Product, PREP
Oral pouch 1g, single dose. One pouch administered over 30 minutes.
Buccal Administration of nicotineProcedure or surgery
Also called Smokeless tobacco, ST, Potential Exposure Reduced Product, PREP
Oral pouch 1g, single dose. One pouch administered over 30 minutes.
Buccal Administration of nicotineProcedure or surgery
Also called Smokeless tobacco, ST, Potential Exposure Reduced Product, PREP
Oral pouch 0.5 g, single dose. One pouch administered over 30 minutes.
Buccal Administration of nicotineProcedure or surgery
Also called Smokeless tobacco, ST, Potential Exposure Reduced Product, PREP
Oral pouch 0.3 g, single dose. One pouch administered over 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| General 1 g pouch | Active comparator | Oral pouch 0.3-1g, single dose. One pouch administered over 30 minutes. Buccal Administration of nicotine. Receives: Procedure: Buccal Administration of nicotine |
| Catch Licoice 1 g pouch | Active comparator | Oral pouch 1g, single dose. One pouch administered over 30 minutes. Buccal Administration of nicotine. Receives: Procedure: Buccal Administration of nicotine |
| Catch Licorice Mini 0.5 g pouch | Active comparator | Oral pouch 0.5g, single dose. One pouch administered over 30 minutes. Buccal Administration of nicotine. Receives: Procedure: Buccal Administration of nicotine |
| Catch Licorice dry mini 0.3 g pouch | Active comparator | Oral pouch 0.3 g, single dose. One pouch administered over 30 minutes. Buccal Administration of nicotine. Receives: Procedure: Buccal Administration of nicotine |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-vivo extraction of cadmium
Extracted amount = mean of 10 unused sachets - residual amount
Measured: 30 minutes' use
Secondary outcomes (3)
in-vivo extraction of tobacco specific nitrosamines (TSNAs)
Extracted amount = mean of 10 unused sachets - residual amount in used sachet
Measured: 30 minutes' use
In-vivo extraction of lead
Extracted amount = mean of 10 unused sachets - residual amount in one used sachet
Measured: 30 minutes' use
In-vivo extraction of nicotine
Extracted amount = mean of 10 unused sachets - residual amount in one used sachet
Measured: 30 minutes' use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startMay 2004
- Primary completionAug 2004
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Contract Research Organization el AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Swedish Match AB
- Responsible party
- Principal investigator, Erik Lunell, MD, PhD, Contract Research Organization el AB
- Investigators
- Erik Lunell, MD, PhD, Principal investigator, Croel AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01838473
- Sponsor's protocol ID
- SMWS03
- Acronym
- SMWS03
- Status last verified
- Apr 2013
- First submitted
- 10 Feb 2012
- Last updated
- 24 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-vivo Extraction of Lead, Cadmium and Tobacco Specific Nitrosamines From Four Brands of Swedish 'Snus' in Regular Snus Users.
- ClinicalTrials.gov ID
- NCT01838473
- Acronym / sponsor ID
- SMWS03 / SMWS03
- Conditions
- Smoking Cessation, Harm Reduction
- Keywords
- smokeless tobacco, Nicotine, Cadmium, lead, Tobacco Specific Nitrosamines
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Contract Research Organization el ABIndustry (pharma, biotech, devices)
- Collaborators
- Swedish Match AB
- Study start
- May 2004
- Primary completion
- Aug 2004 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 24 Apr 2013 (estimated)
- 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.
In an open label, randomized, two-way cross-over study, 32 male healthy regular snus users will be given repeated doses of four different types of portion snus: "General", "Catch", "Catch Mini" and "Catch Dry Mini". Each portion of used snus will be collected and frozen (-20 oC) pending analysis of lead (Pb), cadmium (Cd), nicotine and tobacco specific nitrosamines (TSNAs). Unused snus is collected and deep frozen for analysis and calculation of extracted dose. Calculations of extracted amount of lead, cadmium, nicotine and tobacco specific nitrosamines (TSNAs) respectively, will be done for each type of snus.
Detailed description
Comparisons:
A= "General Portion" 1 g portion snus containing approximately 8 mg nicotine per portion.
B= "Catch Licorice Portion" 1 g portion snus containing approximately 8 mg nicotine per portion.
C= "Catch Licorice Portion Mini" 0.5 g portion snus containing approximately 4 mg nicotine per portion.
D= "Catch Dry Licorice Portion Mini" 0.3 g portion snus containing approximately 4 mg nicotine per portion.
Swedish portion snus will be administered once every hour (4 administrations/brand) and will be kept between the upper lip and the gum for 30 minutes. Preload of own brand each morning.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| General 1 g pouch | Active comparator | Procedure: Buccal Administration of nicotineOral pouch 0.3-1g, single dose. One pouch administered over 30 minutes. Buccal Administration of nicotine. |
| Catch Licoice 1 g pouch | Active comparator | Procedure: Buccal Administration of nicotineOral pouch 1g, single dose. One pouch administered over 30 minutes. Buccal Administration of nicotine. |
| Catch Licorice Mini 0.5 g pouch | Active comparator | Procedure: Buccal Administration of nicotineOral pouch 0.5g, single dose. One pouch administered over 30 minutes. Buccal Administration of nicotine. |
| Catch Licorice dry mini 0.3 g pouch | Active comparator | Procedure: Buccal Administration of nicotineOral pouch 0.3 g, single dose. One pouch administered over 30 minutes. Buccal Administration of nicotine. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- non-smokers, 18 to 50 years of age.
- Habitual use of > 7 portions snus daily since minimum 1 year.
- Healthy according to the health declaration and interview.
- Written informed consent given.
Key exclusion criteria (3 listed)
- Concurrent participation in another clinical trial.
- History of allergy.
- History of allergy.
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 |
|---|---|---|
| Buccal Administration of nicotineAlso: Smokeless tobacco, ST, Potential Exposure Reduced Product, PREPOral pouch 1g, single dose. One pouch administered over 30 minutes. | Procedure or surgery | General 1 g pouch |
| Buccal Administration of nicotineAlso: Smokeless tobacco, ST, Potential Exposure Reduced Product, PREPOral pouch 1g, single dose. One pouch administered over 30 minutes. | Procedure or surgery | Catch Licoice 1 g pouch |
| Buccal Administration of nicotineAlso: Smokeless tobacco, ST, Potential Exposure Reduced Product, PREPOral pouch 0.5 g, single dose. One pouch administered over 30 minutes. | Procedure or surgery | Catch Licorice Mini 0.5 g pouch |
| Buccal Administration of nicotineAlso: Smokeless tobacco, ST, Potential Exposure Reduced Product, PREPOral pouch 0.3 g, single dose. One pouch administered over 30 minutes. | Procedure or surgery | Catch Licorice dry mini 0.3 g pouch |
Primary outcome
In-vivo extraction of cadmium
Time frame: 30 minutes' use
Extracted amount = mean of 10 unused sachets - residual amount
3 secondary outcomes
in-vivo extraction of tobacco specific nitrosamines (TSNAs)
Time frame: 30 minutes' use
In-vivo extraction of lead
Time frame: 30 minutes' use
In-vivo extraction of nicotine
Time frame: 30 minutes' 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 24 Apr 2013.
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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.
Erik Lunell, MD, PhD principal investigator
Croel AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Buccal Administration of nicotine in people with Smoking Cessation and Harm Reduction, run by Contract Research Organization el 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 4 inclusion and 3 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 24 Apr 2013. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
In-vivo extraction of cadmium (time frame: 30 minutes' use). 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 24 Apr 2013.