Nicotine Use DisorderPhase 1NCT02511704
Pharmacokinetics and Acute Effects of Multiple Dose of Nicotine: Electronic Cigarette and Cigarette
A Phase 1 study testing Nicotine in people with Nicotine Use Disorder, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
The purposes of this study are 1) to determine the pharmacokinetics of nicotine after multiple dose administration by electronic cigarette and 2) to compare the acute effects of multiple dose of nicotine administrated by electronic cigarette compared with those obteined by cigarette. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Nicotine Use Disorder
- What is being tested?
- Nicotine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2014to Dec 2014
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Understanding and accepting the study procedures and signing the informed consent.
- Male adults volunteers (18-45 years old).
- Clinical history and physical examination demonstrating no organic or psychiatric disorders.
- The ECG and general blood and urine laboratory tests performed before the study should be within normal ranges. Minor or occasional changes from normal ranges are accepted if, in the investigator's opinion, considering the current state of the art, they are not clinically significant, are not life-threatening for the subjects and do not interfere with the product assessment. These changes and their non-relevance will be justified in writing specifically.
- Present use of nicotine without serious adverse reactions.
- Smokers ≥ 3 cigarettes/day.
Who cannot join
- Having suffered any cardiovascular and/or respiratory disease in the three months prior to the study start.
- History of drug dependence (except for nicotine dependence).
- Daily consumption >4 standard units of ethanol.
- Regular use of any drug in the month prior to the study sessions. The treatment with single or limited doses of symptomatic medicinal products in the week prior to the study sessions will not be a reason for exclusion if it is calculated that it has been cleared completely the day of the experimental session.
- Having suffered any organic disease or major surgery in the three months prior to the study start.
- Blood donation 12 weeks before or participation in other clinical trials with drugs in the previous 12 weeks.
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- History or clinical evidence of gastrointestinal, liver, renal or other disorders which may lead to suspecting a disorder in drug absorption, distribution, metabolism or excretion, or that suggest gastrointestinal irritation due to drugs.
- Subjects unable to understand the nature, consequences of the study and the procedures requested to be followed.
- Use of any drug or substance inhibitor of cytochrome P-450-1A6 (CYP1A6) (p.e. raloxifene, coumarins, etc)
Trial locations and contacts
1 site in 1 country.
Spain1 site
Institut Hospital del Mar d'Investigacions Mèdiques-IMIM. Parc de Salut Mar.
Barcelona, Barcelona, 08003
About this study
Official title: Pharmacokinetics and Acute Effects of Multiple Dose of Nicotine Administered by Electronic Cigarette and Cigarette
The purposes of this study are 1) to determine the pharmacokinetics of nicotine after multiple dose administration by electronic cigarette and 2) to compare the acute effects of multiple dose of nicotine administrated by electronic cigarette compared with those obteined by cigarette.
Read the detailed description
Electronic cigarettes (e-cigarettes) are battery-operated devices that deliver nicotine via inhaled vapour or "vaping". At present, e-cigarettes are becoming increasingly popular among smokers worldwide. However, knowledge about e-cigarette nicotine pharmacology remains limited.
The aims of this study are 1) to determine the pharmacokinetics of nicotine after multiple dose administration by electronic cigarette and 2) to compare the acute effects of multiple dose of nicotine administrated by electronic cigarette compared with those obteined by cigarette.
- Conditions
- Nicotine Use Disorder
- Being tested
- Nicotine
- Keywords
- Nicotine, Electronic cigarette, Cigarette
- Medical subject headings
- Tobacco Use Disorder, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicotineDrug
Also called Nhoss®
Multiple dose nicotine
NicotineDrug
Also called Marlboro®
Multiple dose nicotine
| Study group | Role | What they receive |
|---|---|---|
| Electronic cigarette | Experimental | Multiple dose
Nicotine 0.8 mg, administrated by electronic cigarette (10 puffs) + Nicotine 0.8 mg, administrated by electronic cigarette (10 puffs) separated by 60 minutes Receives: Drug: Nicotine |
| Cigarette | Active comparator | Multiple dose
Nicotine 0.8 mg, administrated by cigarette (10 puffs) + Nicotine 0.8 mg, administrated by cigarette (10 puffs) separated by 60 minutes Receives: Drug: Nicotine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration-Time Curve (AUC 0-24h)
Calculation of AUC of the concentrations of nicotine and its metabolites in blood
Measured: From baseline (pre-dose, 0h) to 5, 15, 30, 45, 55, 65, 75, 90, 105, 120 and 24h post-dose
Secondary outcomes (11)
Area Under the Concentration-Time Curve (AUC 0-24h)
Calculation of AUC of the concentrations of nicotine and its metabolites in urine
Measured: From baseline (pre-dose, 0h) to 55, 120 min, 6, 12 and 24h
Area Under the Concentration-Time Curve (AUC 0-24h)
Calculation of AUC of the concentrations of nicotine and its metabolites in oral fluid
Measured: From baseline (pre-dose, 0h) to 15, 30, 45, 55, 65, 75, 90, 105, 120 min, 6, 12 and 24h
Number of Participants with Serious and Non-Serious Adverse Events
Collection of adverse effects spontaneously reported by the participants and/or observed by the investigators
Measured: 2 days after each substance administration
Elimination half-life
Calculation of elimination hal-life from concentrations of nicotine and its metabolites in plasma-blood, urine and oral fluid.
Measured: From baseline to 24h post-dose
Changes in blood pressure
Measure of blood pressure (systolic and diastolic blood pressure)
Measured: From pre-dose (baseline) to 120 min post-dose
Changes in heart rate
Measure of heart rate (pulse)
Measured: From pre-dose (baseline) to 120 min post-dose
Changes in expired carbon monoxide (CO) aire
Measure of expired CO aire using a BreathCO monitor
Measured: From pre-dose (baseline) to 120 min post-dose
Changes in pupil diameter
Measure of pupil diameter using a Haab pupil gauge
Measured: From pre-dose (baseline) to 120 min post-dose
Changes in oral temperature
Measure of temperature in mouth using automatic thermometer
Measured: From pre-dose (baseline) to 120 min post-dose
Changes in subjective effects
Subjective effects will be measured using rate scales (visual analogue scales) including measures of good effects and other feelings induced by nicotine
Measured: From pre-dose (baseline) to 120 min post-dose
Changes in nicotine abstinence symptoms
Nicotine abstinence symptoms will be measured using rate scales (visual analogue scales) including items sensitive to nicotine effects
Measured: From pre-dose (baseline) to 120 min post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startOct 2014
- Primary completionNov 2014
- Study completionDec 2014
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 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Superiore di Sanità
- Responsible party
- Sponsor
- Investigators
- Magi Farre, MD, PhD, Principal investigator, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511704
- Sponsor's protocol ID
- IMIMFTCL/CIG-E/1
- Status last verified
- Dec 2014
- First submitted
- 28 Jul 2015
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Acute Effects of Multiple Dose of Nicotine Administered by Electronic Cigarette and Cigarette
- ClinicalTrials.gov ID
- NCT02511704
- Acronym / sponsor ID
- IMIMFTCL/CIG-E/1
- Conditions
- Nicotine Use Disorder
- Keywords
- Nicotine, Electronic cigarette, Cigarette
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Collaborators
- Istituto Superiore di Sanità
- Study start
- Oct 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Jul 2015 (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 purposes of this study are 1) to determine the pharmacokinetics of nicotine after multiple dose administration by electronic cigarette and 2) to compare the acute effects of multiple dose of nicotine administrated by electronic cigarette compared with those obteined by cigarette.
Detailed description
Electronic cigarettes (e-cigarettes) are battery-operated devices that deliver nicotine via inhaled vapour or "vaping". At present, e-cigarettes are becoming increasingly popular among smokers worldwide. However, knowledge about e-cigarette nicotine pharmacology remains limited.
The aims of this study are 1) to determine the pharmacokinetics of nicotine after multiple dose administration by electronic cigarette and 2) to compare the acute effects of multiple dose of nicotine administrated by electronic cigarette compared with those obteined by cigarette.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electronic cigarette | Experimental | Drug: NicotineMultiple dose Nicotine 0.8 mg, administrated by electronic cigarette (10 puffs) + Nicotine 0.8 mg, administrated by electronic cigarette (10 puffs) separated by 60 minutes |
| Cigarette | Active comparator | Drug: NicotineMultiple dose Nicotine 0.8 mg, administrated by cigarette (10 puffs) + Nicotine 0.8 mg, administrated by cigarette (10 puffs) separated by 60 minutes |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Understanding and accepting the study procedures and signing the informed consent.
- Male adults volunteers (18-45 years old).
- Clinical history and physical examination demonstrating no organic or psychiatric disorders.
- The ECG and general blood and urine laboratory tests performed before the study should be within normal ranges. Minor or occasional changes from normal ranges are accepted if, in the investigator's opinion, considering the current state of the art, they are not clinically significant, are not life-threatening for the subjects and do not interfere with the product assessment. These changes and their non-relevance will be justified in writing specifically.
- Present use of nicotine without serious adverse reactions.
Key exclusion criteria (9 listed)
- Having suffered any cardiovascular and/or respiratory disease in the three months prior to the study start.
- History of drug dependence (except for nicotine dependence).
- Daily consumption >4 standard units of ethanol.
- Regular use of any drug in the month prior to the study sessions. The treatment with single or limited doses of symptomatic medicinal products in the week prior to the study sessions will not be a reason for exclusion if it is calculated that it has been cleared completely the day of the experimental session.
- Having suffered any organic disease or major surgery in the three months prior to the study start.
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 |
|---|---|---|
| NicotineAlso: Nhoss®Multiple dose nicotine | Drug | Electronic cigarette |
| NicotineAlso: Marlboro®Multiple dose nicotine | Drug | Cigarette |
Primary outcome
Area Under the Concentration-Time Curve (AUC 0-24h)
Time frame: From baseline (pre-dose, 0h) to 5, 15, 30, 45, 55, 65, 75, 90, 105, 120 and 24h post-dose
Calculation of AUC of the concentrations of nicotine and its metabolites in blood
11 secondary outcomes
Area Under the Concentration-Time Curve (AUC 0-24h)
Time frame: From baseline (pre-dose, 0h) to 55, 120 min, 6, 12 and 24h
Area Under the Concentration-Time Curve (AUC 0-24h)
Time frame: From baseline (pre-dose, 0h) to 15, 30, 45, 55, 65, 75, 90, 105, 120 min, 6, 12 and 24h
Number of Participants with Serious and Non-Serious Adverse Events
Time frame: 2 days after each substance administration
Elimination half-life
Time frame: From baseline to 24h post-dose
Changes in blood pressure
Time frame: From pre-dose (baseline) to 120 min post-dose
Changes in heart rate
Time frame: From pre-dose (baseline) to 120 min post-dose
Changes in expired carbon monoxide (CO) aire
Time frame: From pre-dose (baseline) to 120 min post-dose
Changes in pupil diameter
Time frame: From pre-dose (baseline) to 120 min post-dose
Changes in oral temperature
Time frame: From pre-dose (baseline) to 120 min post-dose
Changes in subjective effects
Time frame: From pre-dose (baseline) to 120 min post-dose
Changes in nicotine abstinence symptoms
Time frame: From pre-dose (baseline) to 120 min post-dose
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 30 Jul 2015.
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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.
Magi Farre, MD, PhD principal investigator
Parc de Salut Mar
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 Nicotine in people with Nicotine Use Disorder, run by Parc de Salut Mar at 1 site in Spain.
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 30 Jul 2015. 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 Spain. 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?
Area Under the Concentration-Time Curve (AUC 0-24h) (time frame: From baseline (pre-dose, 0h) to 5, 15, 30, 45, 55, 65, 75, 90, 105, 120 and 24h post-dose). 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 30 Jul 2015.