Smoking CessationPhase 1/2NCT01838460
Sublingual Nicotine Tablets Compared With Swedish Snus
A Phase 1/2 study testing sublingual nicotine tablets and Smokeless tobacco in people with Smoking Cessation, run by Contract Research Organization el AB at 1 site in Sweden.
Trial summary
To compare each subject's AUCinf, after administration of one single dose of 6 mg of Nicorette sublingual nicotine tablets ( three 2mg tablets) to that of one single 1 g dose of SS containing 16 mg nicotine. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- sublingual nicotine tablets and Smokeless tobacco
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSweden
- Study dates
- May 2012to Feb 2013
- Phase
- Phase 1/2
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Consent to participate voluntarily and sign Informed Consent Form prior to any study procedure.
- Healthy male/female, age 18 through 50 years. Female using contraceptive pill or negative pregnancy test.
- Willing and able to comply with study procedures.
- Snus user, minimum 12 pouches or half a can of loose snus per day of pouched portion snus, minimum 1 gram/portion.
- Abstinent from any form of nicotine use from 8.00 p.m.
- Fasting overnight from 11.00 p.m.
Who cannot join
- Smoker, defined as "smoking during the last 24 hours according to self report and CO in exhaled air >10 ppm at clinical visits"
- Second or third degree AV block or sick sinus syndrome; congestive heart failure classified as functional Class III or IV by the New York Heart Association; myocardial infarction within six months of baseline; a prolonged QTc interval at screen or pretreatment (defined as a QTc interval of > 450 msec for males or > 470 msec for females); other clinically significant heart conditions which would negatively impact on the subject completing the study.
- Subjects with clinically significant liver disease which may prevent the subject from completing the study and/or an elevation in total bilirubin, alkaline phosphatase, LDH, ASAT, or ALAT of > 3 times the upper limit of the laboratory reference interval.
- Subjects with clinically significant renal disease which may prevent the subject from completing the study and/or an elevation in serum creatinine of > 1.5 times the laboratory reference.
- Surgery within 6 months of the Baseline visit that, in the opinion of the investigator, could negatively impact on the subject's participation in the clinical study.
- Subjects who have participated in other drug studies within 30 days prior to enrolment.
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- Subjects with any surgical or medical condition, which, in the judgment of the clinical investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug.
- Subjects who are using drugs capable of inducing hepatic enzyme metabolism within the previous 30 days (or 5 half lives of inducing agent, whichever is longer) of enrolment in this study.
- Subjects with a medical history of seizures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Elevated Dose of Sublingual Nicotine Tablets Compared With Swedish Snus. Nicotine Pharmacokinetics and Subjective Effects of Single Doses.
To compare each subject's AUCinf, after administration of one single dose of 6 mg of Nicorette sublingual nicotine tablets ( three 2mg tablets) to that of one single 1 g dose of SS containing 16 mg nicotine.
Read the detailed description
Open, randomized, five-way cross-over. Single dose administration. The Nicorette 6 mg sublingual tablets and three strengths of SS are tested. Subjects are 18-50 years old, male/female (non-pregnant), healthy volunteer, using minimum 12 pouches of 1 g portion snus or half a can of loose snus per day. The treatments are given as single doses in randomized order. The subject keeps the sublingual tablets still under the tongue for 30 minutes.
The subject keeps the pouch(es) of snus still between the upper lip and the gum for 30 minutes. Serial blood samples are drawn before, and at regular time intervals up to 6 hours after administration.
Amount of nicotine extracted, plasma nicotine concentration at 30 minutes (C30), Tmax, Cmax, AUCinf and heart rate for each treatment. The AUCinf area is based on plasma data corrected for background nicotine (time zero sample).
Each subject's rating of subjective effects using a Visual Analogue Scale (VAS) on a palm top computer, anchored with "not at all" to "extremely".
VAS scores will be obtained at the plasma concentrations sampling time points up to 30 minutes for:
- craving intensity
- overall "product strength" (head rush, "buzz", "hit", feeling alert)
- increased salivation
- burning sensation in the mouth and/or throat
- Conditions
- Smoking Cessation
- Being tested
- sublingual nicotine tablets, Smokeless tobacco
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sublingual nicotine tabletsDrug
Also called Nicorette Sublingual Tablets
6 mg = 3 tablets
Smokeless tobaccoOther
Also called PSWM 0.5 g, PSWL 1.0 g
Swedish type moist snuff
| Study group | Role | What they receive |
|---|---|---|
| 6 mg dose of sublingual nicotine tablets | Experimental | 6 mg dose of sublingual nicotine tablets, single dose. Receives: Drug: sublingual nicotine tablets |
| PSWM 0.5 g (16 mg nicotine/g) | Active comparator | Swedish portion snus, smokeless tobacco, PSWM 0.5 g (16 mg nicotine/g), single dose Receives: Other: Smokeless tobacco |
| PSWL 1.0 g (8 mg nicotine /g) | Active comparator | Swedish portion snus, smokeless tobacco, PSWL 1.0 g (8 mg nicotine /g), single dose Receives: Other: Smokeless tobacco |
| PSWL 1.0 g (16 mg nicotine /g) | Active comparator | Swedish portion snus, smokeless tobacco, PSWL 1.0 g (16 mg nicotine /g), single dose Receives: Other: Smokeless tobacco |
| PSWL (8 mg nicotine /g) 2x1.0 g | Active comparator | Swedish portion snus, smokeless tobacco, PSWL (8 mg nicotine /g) 2x1.0 g, single dose Receives: Other: Smokeless tobacco |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCinf
Measured: 6 hours
Secondary outcomes (4)
craving intensity
Measured: 6 hours
head rush
overall "product strength" (head rush, "buzz", "hit", feeling alert
Measured: 6 hours
burning sensation
burning sensation in the mouth and/or throat
Measured: 6 hours
increased salivation
Measured: 6 hours
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 2012
- Primary completionAug 2012
- Study completionFeb 2013
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Contract Research Organization el AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Commitum 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
- NCT01838460
- Sponsor's protocol ID
- SM WS 12
- Status last verified
- Apr 2013
- First submitted
- 19 Feb 2013
- 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
- Elevated Dose of Sublingual Nicotine Tablets Compared With Swedish Snus. Nicotine Pharmacokinetics and Subjective Effects of Single Doses.
- ClinicalTrials.gov ID
- NCT01838460
- Acronym / sponsor ID
- SM WS 12
- Conditions
- Smoking Cessation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Contract Research Organization el ABIndustry (pharma, biotech, devices)
- Collaborators
- Commitum AB
- Study start
- May 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Feb 2013 (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.
To compare each subject's AUCinf, after administration of one single dose of 6 mg of Nicorette sublingual nicotine tablets ( three 2mg tablets) to that of one single 1 g dose of SS containing 16 mg nicotine.
Detailed description
Open, randomized, five-way cross-over. Single dose administration. The Nicorette 6 mg sublingual tablets and three strengths of SS are tested. Subjects are 18-50 years old, male/female (non-pregnant), healthy volunteer, using minimum 12 pouches of 1 g portion snus or half a can of loose snus per day. The treatments are given as single doses in randomized order. The subject keeps the sublingual tablets still under the tongue for 30 minutes.
The subject keeps the pouch(es) of snus still between the upper lip and the gum for 30 minutes. Serial blood samples are drawn before, and at regular time intervals up to 6 hours after administration.
Amount of nicotine extracted, plasma nicotine concentration at 30 minutes (C30), Tmax, Cmax, AUCinf and heart rate for each treatment. The AUCinf area is based on plasma data corrected for background nicotine (time zero sample).
Each subject's rating of subjective effects using a Visual Analogue Scale (VAS) on a palm top computer, anchored with "not at all" to "extremely".
VAS scores will be obtained at the plasma concentrations sampling time points up to 30 minutes for:
- craving intensity
- overall "product strength" (head rush, "buzz", "hit", feeling alert)
- increased salivation
- burning sensation in the mouth and/or throat
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 6 mg dose of sublingual nicotine tablets | Experimental | Drug: sublingual nicotine tablets6 mg dose of sublingual nicotine tablets, single dose. |
| PSWM 0.5 g (16 mg nicotine/g) | Active comparator | Other: Smokeless tobaccoSwedish portion snus, smokeless tobacco, PSWM 0.5 g (16 mg nicotine/g), single dose |
| PSWL 1.0 g (8 mg nicotine /g) | Active comparator | Other: Smokeless tobaccoSwedish portion snus, smokeless tobacco, PSWL 1.0 g (8 mg nicotine /g), single dose |
| PSWL 1.0 g (16 mg nicotine /g) | Active comparator | Other: Smokeless tobaccoSwedish portion snus, smokeless tobacco, PSWL 1.0 g (16 mg nicotine /g), single dose |
| PSWL (8 mg nicotine /g) 2x1.0 g | Active comparator | Other: Smokeless tobaccoSwedish portion snus, smokeless tobacco, PSWL (8 mg nicotine /g) 2x1.0 g, single dose |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Consent to participate voluntarily and sign Informed Consent Form prior to any study procedure.
- Healthy male/female, age 18 through 50 years. Female using contraceptive pill or negative pregnancy test.
- Willing and able to comply with study procedures.
- Snus user, minimum 12 pouches or half a can of loose snus per day of pouched portion snus, minimum 1 gram/portion.
- Abstinent from any form of nicotine use from 8.00 p.m.
Key exclusion criteria (9 listed)
- Smoker, defined as "smoking during the last 24 hours according to self report and CO in exhaled air >10 ppm at clinical visits"
- Second or third degree AV block or sick sinus syndrome; congestive heart failure classified as functional Class III or IV by the New York Heart Association; myocardial infarction within six months of baseline; a prolonged QTc interval at screen or pretreatment (defined as a QTc interval of > 450 msec for males or > 470 msec for females); other clinically significant heart conditions which would negatively impact on the subject completing the study.
- Subjects with clinically significant liver disease which may prevent the subject from completing the study and/or an elevation in total bilirubin, alkaline phosphatase, LDH, ASAT, or ALAT of > 3 times the upper limit of the laboratory reference interval.
- Subjects with clinically significant renal disease which may prevent the subject from completing the study and/or an elevation in serum creatinine of > 1.5 times the laboratory reference.
- Surgery within 6 months of the Baseline visit that, in the opinion of the investigator, could negatively impact on the subject's participation in the clinical 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 |
|---|---|---|
| sublingual nicotine tabletsAlso: Nicorette Sublingual Tablets6 mg = 3 tablets | Drug | 6 mg dose of sublingual nicotine tablets |
| Smokeless tobaccoAlso: PSWM 0.5 g, PSWL 1.0 gSwedish type moist snuff | Other | PSWL (8 mg nicotine /g) 2x1.0 g, PSWL 1.0 g (16 mg nicotine /g), PSWL 1.0 g (8 mg nicotine /g), PSWM 0.5 g (16 mg nicotine/g) |
Primary outcome
AUCinf
Time frame: 6 hours
4 secondary outcomes
craving intensity
Time frame: 6 hours
head rush
Time frame: 6 hours
burning sensation
Time frame: 6 hours
increased salivation
Time frame: 6 hours
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 1/2 study testing sublingual nicotine tablets and Smokeless tobacco in people with Smoking Cessation, 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 6 inclusion and 9 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
AUCinf (time frame: 6 hours). 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.