Nicotine Replacement TherapyPhase 1NCT02794220
A Study of Blood Levels of Nicotine Following an Electronic Cigarette
A Phase 1 study testing CN electronic cigarette 10 mg, CN electronic cigarette 15 mg and Nicorette Inhalator 15 mg in people with Nicotine Replacement Therapy, run by Simbec Research.
Trial summary
The purpose of this study is to assess the amount of nicotine that is absorbed into the blood stream following the use of a new Electronic Cigarette device called the CN electronic cigarette. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Nicotine Replacement Therapy
- What is being tested?
- CN electronic cigarette 10 mg, CN electronic cigarette 15 mg and Nicorette Inhalator 15 mg
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Feb 2013
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of signed written informed consent.
- Males aged 18-65 years.
- Subject with a Body Mass Index (BMI) of 18-30 Body Mass Index = Body weight (kg) / [Height (m)]2.
- Regular moderate cigarette smokers (approximately 10 to 20 cigarettes per day for at least 5 years) who are not intending to make a quit attempt during the study.
- No obvious symptoms of ill health as determined during the pre-study medical examination (to be performed within 4 weeks of the first dose).
- Subject with no clinically significant abnormalities in 12-lead electrocardiogram (ECG), including normal resting ECG with QTcB interval of less than 440 ms determined within 4 weeks of the first dose.
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- No clinically significant abnormalities in blood pressure values (the differences between supine and standing BP are less than 20 mmHg) with no symptomatic evidence of postural hypotension.
- Subject with no clinically significant abnormal serum biochemistry, haematology and urine examination values within 4 weeks of the first dose.
- Subject with a negative urinary drugs of abuse screen (excluding nicotine), determined within 4 weeks of the first dose (N.B. a positive alcohol result may be repeated at the discretion of the Investigator).
- Subject with negative HIV and Hepatitis B and C results.
- To be re-confirmed at Day 0:
- Subject continues to meet all screening inclusion criteria.
- Subject with a negative urinary drugs of abuse screen (including alcohol) prior to dosing
Who cannot join
- To be confirmed at Screening Visit:
- Evidence of renal, hepatic, central nervous system, respiratory (including COPD), cardiovascular or metabolic dysfunction.
- Known allergy to any ingredients of the study medication.
- A history of or current drug or alcohol abuse.
- Inability to communicate well with the Investigator/study staff (i.e., language problem, poor mental development or impaired cerebral function).
- Participation in a New Chemical Entity clinical study within the previous 4 months or a marketed drug clinical study within the previous 3 months (N.B. washout period between trials defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study..
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- Donation of 450ml or more blood within the previous 3 months.
- Any other clinically significant medical history, in theInvestigator's opinion, including conditions which might affect drug absorption, metabolism or excretion.
- Unlikely to comply with trial visit schedule or with trial medication dosing requirements.
- Severe intercurrent illness which, in the opinion of the Investigator, may put the subject at risk when participating in the trial or may influence the results of the trial or affect the subjects' ability to take part in the trial.
- Excessive intake of alcohol, defined as a regular maximum weekly intake of greater than 28 units for men (1 unit equals half a pint of beer, 1 small glass of wine or 1 x 25 mL measure of spirits) within the last 6 months.
- Treatment with smoking cessation medications (bupropion, Champix, any NRT) within 8 weeks of the planned first nicotine dosing occasion.
- Treatment with prescription medications within 21 days or over-the-counter medication within 72 hours of the planned first nicotine dosing occasion.
- Clinical judgement by the Investigator that the subject should not participate in the study for any other reason.
- To be re- confirmed at Day 0:
- Development of any exclusion criteria since screening
- Receipt of any medication since screening visit that may have an impact on the safety and objectives of the study (at the Investigator's discretion).
About this study
Official title: A Randomised, 4-way Crossover, Relative Bioavailability Study of Nicotine Delivered by an Electronic Cigarette, Nicorette® Inhalator and Cigarette Smoking
The purpose of this study is to assess the amount of nicotine that is absorbed into the blood stream following the use of a new Electronic Cigarette device called the CN electronic cigarette. The amount of nicotine delivered via the CN electronic cigarette will be compared to the amount of nicotine delivered from smoking a regular cigarette and from using the Nicorette® Inhalator.
Electronic cigarettes aim to mimic the experience of cigarette smoking, by delivering nicotine rapidly. Unlike cigarettes however, they do not contain all of the many harmful combustion products contained in tobacco smoke.
Read more
Electronic cigarettes are readily available in many markets, and may contain significant quantities of nicotine. However, they are not regulated as medicines, and their manufacturers can make no medicinal claims about them.
Such products are unregulated, having not been subjected to regulatory review by either the Medicines and Healthcare Products Regulatory Agency (MHRA) or any Notified Body.
It is the intention of CN Creative (makers of the CN electronic cigarette) to submit an application to the MHRA for the CN Electronic Cigarette, in order to make a high quality, regulated product available. Males aged 18-65, who smoke and who have no intention of stopping smoking during the trial are eligible to take part in this study. The study consist of a screening visit, a treatment period with 5 overnight stays with nicotine treatment on days 1, 2, 3 and 4 with a post study visit on day 5.
- Conditions
- Nicotine Replacement Therapy
- Being tested
- CN electronic cigarette 10 mg, CN electronic cigarette 15 mg, Nicorette Inhalator 15 mg, Cigarette
- Keywords
- E-cigarette, healthy volunteer study, Pharmacokinetics, Nicorette
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CN electronic cigarette 10 mgDevice
Inhalation
CN electronic cigarette 15 mgDevice
Inhalation
Nicorette Inhalator 15 mgDevice
Inhalation
CigaretteOther
Inhalation
| Study group | Role | What they receive |
|---|---|---|
| CN Electronic cigarette 10 mg | Experimental | 10 mg strength
- Administration once every hour for a total of 4 hours. Receives: Device: CN electronic cigarette 10 mg |
| CN Electronic cigarette 15 mg | Experimental | 15 mg strength
- Administration once every hour for a total of 4 hours. Receives: Device: CN electronic cigarette 15 mg |
| Nicorette Inhalator 15 mg | Active comparator | 15 mg strength
- Administration once every hour for a total of 4 hours. Receives: Device: Nicorette Inhalator 15 mg |
| Cigarette | Active comparator | Subjects will all smoke the same brand.
- Administration once every hour for a total of 4 hours. Receives: Other: Cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax: The peak serum concentration of nicotine.
PK samples taken after 4th administration immediately after dosing and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 30, 60 minutes, and 2, 4, 6, 8, 12 and 20 hours afterwards. The pre-dose blood sample drawn on days 2, 3 and 4 will also serve as the 20 hour sample
Measured: 0 to 20h, PK parameters calculated after 4th Administration
Secondary outcomes (4)
AUC0-t
Measured: 0 to 20h, PK parameters calculated after 4th Administration
Tmax
Measured: 0 to 20h, PK parameters calculated after 4th Administration
t½
Measured: 0 to 20h
Cmin
Measured: 0 to 20h, PK parameters calculated after 4th Administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2016 (estimated)
- Study startAug 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine Replacement TherapyStudies 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
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Simbec Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CN creative
- Responsible party
- Principal investigator, Girish Sharma, Simbec Research
- Investigators
- Girish Sharma, MBBS, Principal investigator, Simbec Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794220
- Sponsor's protocol ID
- RD 655/25310
- Status last verified
- Jun 2016
- First submitted
- 3 Jun 2016
- Last updated
- 9 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Yes, data has been shared on EudRACT in the form of a poster presentation. Sharma G, Lawson D, Edwards C et al. A Novel Electronic Cigarette with Advanced Vaporization Technology: Nicotine Pharmacokinetics (PK), Safety and Tolerability. Poster presentation at 21st Annual Meeting of the Society of Research on Nicotine and Tobacco (SRNT); Philadelphia, USA; February 25 - 28 2015
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, 4-way Crossover, Relative Bioavailability Study of Nicotine Delivered by an Electronic Cigarette, Nicorette® Inhalator and Cigarette Smoking
- ClinicalTrials.gov ID
- NCT02794220
- Acronym / sponsor ID
- RD 655/25310
- Conditions
- Nicotine Replacement Therapy
- Keywords
- E-cigarette, healthy volunteer study, Pharmacokinetics, Nicorette
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Simbec ResearchIndustry (pharma, biotech, devices)
- Collaborators
- CN creative
- Study start
- Aug 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 9 Jun 2016 (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.
The purpose of this study is to assess the amount of nicotine that is absorbed into the blood stream following the use of a new Electronic Cigarette device called the CN electronic cigarette. The amount of nicotine delivered via the CN electronic cigarette will be compared to the amount of nicotine delivered from smoking a regular cigarette and from using the Nicorette® Inhalator.
Electronic cigarettes aim to mimic the experience of cigarette smoking, by delivering nicotine rapidly. Unlike cigarettes however, they do not contain all of the many harmful combustion products contained in tobacco smoke.
Electronic cigarettes are readily available in many markets, and may contain significant quantities of nicotine. However, they are not regulated as medicines, and their manufacturers can make no medicinal claims about them.
Such products are unregulated, having not been subjected to regulatory review by either the Medicines and Healthcare Products Regulatory Agency (MHRA) or any Notified Body.
It is the intention of CN Creative (makers of the CN electronic cigarette) to submit an application to the MHRA for the CN Electronic Cigarette, in order to make a high quality, regulated product available. Males aged 18-65, who smoke and who have no intention of stopping smoking during the trial are eligible to take part in this study. The study consist of a screening visit, a treatment period with 5 overnight stays with nicotine treatment on days 1, 2, 3 and 4 with a post study visit on day 5.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CN Electronic cigarette 10 mg | Experimental | Device: CN electronic cigarette 10 mg10 mg strength - Administration once every hour for a total of 4 hours. |
| CN Electronic cigarette 15 mg | Experimental | Device: CN electronic cigarette 15 mg15 mg strength - Administration once every hour for a total of 4 hours. |
| Nicorette Inhalator 15 mg | Active comparator | Device: Nicorette Inhalator 15 mg15 mg strength - Administration once every hour for a total of 4 hours. |
| Cigarette | Active comparator | Other: CigaretteSubjects will all smoke the same brand. - Administration once every hour for a total of 4 hours. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Provision of signed written informed consent.
- Males aged 18-65 years.
- Subject with a Body Mass Index (BMI) of 18-30 Body Mass Index = Body weight (kg) / [Height (m)]2.
- Regular moderate cigarette smokers (approximately 10 to 20 cigarettes per day for at least 5 years) who are not intending to make a quit attempt during the study.
- No obvious symptoms of ill health as determined during the pre-study medical examination (to be performed within 4 weeks of the first dose).
Key exclusion criteria (17 listed)
- To be confirmed at Screening Visit:
- Evidence of renal, hepatic, central nervous system, respiratory (including COPD), cardiovascular or metabolic dysfunction.
- Known allergy to any ingredients of the study medication.
- A history of or current drug or alcohol abuse.
- Inability to communicate well with the Investigator/study staff (i.e., language problem, poor mental development or impaired cerebral function).
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 |
|---|---|---|
| CN electronic cigarette 10 mgInhalation | Device | CN Electronic cigarette 10 mg |
| CN electronic cigarette 15 mgInhalation | Device | CN Electronic cigarette 15 mg |
| Nicorette Inhalator 15 mgInhalation | Device | Nicorette Inhalator 15 mg |
| CigaretteInhalation | Other | Cigarette |
Primary outcome
Cmax: The peak serum concentration of nicotine.
Time frame: 0 to 20h, PK parameters calculated after 4th Administration
PK samples taken after 4th administration immediately after dosing and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 30, 60 minutes, and 2, 4, 6, 8, 12 and 20 hours afterwards. The pre-dose blood sample drawn on days 2, 3 and 4 will also serve as the 20 hour sample
4 secondary outcomes
AUC0-t
Time frame: 0 to 20h, PK parameters calculated after 4th Administration
Tmax
Time frame: 0 to 20h, PK parameters calculated after 4th Administration
t½
Time frame: 0 to 20h
Cmin
Time frame: 0 to 20h, PK parameters calculated after 4th Administration
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 9 Jun 2016.
- Individual participant dataSharing planned: Yes. Yes, data has been shared on EudRACT in the form of a poster presentation. Sharma G, Lawson D, Edwards C et al. A Novel Electronic Cigarette with Advanced Vaporization Technology: Nicotine Pharmacokinetics (PK), Safety and Tolerability. Poster presentation at 21st Annual Meeting of the Society of Research on Nicotine and Tobacco (SRNT); Philadelphia, USA; February 25 - 28 2015
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iCanQuit Smoking Cessation Among Hispanic Adults
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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.
Girish Sharma, MBBS principal investigator
Simbec Research
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CN electronic cigarette 10 mg, CN electronic cigarette 15 mg and Nicorette Inhalator 15 mg in people with Nicotine Replacement Therapy, run by Simbec Research.
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 13 inclusion and 17 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 9 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Cmax: The peak serum concentration of nicotine. (time frame: 0 to 20h, PK parameters calculated after 4th Administration). 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 9 Jun 2016.