Tobacco Use DisorderPhase 1NCT02906995
Pharmacokinetics of Nicotine Sublingual Tablets Versus Nicorette Lozenge in Healthy Smokers
A Phase 1 study testing Sublingual tablet 4 mg versus Nicorette Lozenge 4mg in people with Tobacco Use Disorder and Cigarette Smoking, run by Friends Research Institute, Inc. at 1 site in United States.
Trial summary
The purpose of the study is to compare two different dosage forms from which nicotine is released and absorbed into the bloodstream. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder, Cigarette Smoking
- What is being tested?
- Sublingual tablet 4 mg versus Nicorette Lozenge 4mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2017to 27 Nov 2017
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants have to be 18-45 years old
- Participants must provide written informed consent prior to any study related procedures being performed.
- Participants must have a willingness and ability to comply with the protocol requirements.
- Participants must be in good health and free from any clinically significant pathology (gastrointestinal tract, hepatic, renal, cardiovascular, CNS diseases)
- Female participants of childbearing potential, in addition to having a negative urine pregnancy test, must be willing to use a form of birth control during the study. The hormonal contraceptives should be avoided within 2 month prior to study entry.
- Participants must consume more than 10 cigarettes daily and Fagerström Test for Nicotine Dependence score of 4 or greater.
- Participants must have no intention of quitting smoking in the next 60 days.
Who cannot join
- Volunteers that have used other nicotine delivery system such as nicotine lozenge, nicotine patch, nicotine inhaler, or nicotine nasal spray etc within 30 days of study entry.
- Volunteers who have currently involved in another clinical trial or have used any investigational drug within 3 month of study entry.
- Volunteers who are pregnant or lactating, or plan to become pregnant within 6 months.
- Volunteers who have diagnosed heart disease or are being treated with medication or had an irregular heartbeat or have had a myocardial infarction.
- Volunteers with diagnosed stomach ulcers.
- Volunteers who are taking insulin for diabetes.
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- Volunteers with high blood pressure not controlled by medication or a blood pressure greater than 150 mmHg systolic or 90 mmHg diastolic.
- Volunteers who are unable to fulfill the visit schedule
- Volunteers who have severe allergic history
- Volunteers who have known intolerance to medication
- Volunteers who have diagnosed chronic diseases of cardiovascular, pulmonary, neuro-endocrine systems, gastrointestinal, hepatic, renal, and blood diseases
- Volunteers who had surgical operations on gastrointestinal tract with the exception of appendectomy
- Volunteers who donated 450 mL and more of his/her blood or blood plasma within the last 2 months prior to the study entry
- Volunteers who meet criteria for dependence on a substance other than nicotine.
- Participants having a body mass index below 18 or over 35.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Pseudorandomized, Two Way Crossover Comparison of the Single-Dose Pharmacokinetics of Nicotine 4 mg Sublingual Tablets Versus Nicorette Lozenge 4 mg in Healthy Smokers Under Fasted Conditions
The purpose of the study is to compare two different dosage forms from which nicotine is released and absorbed into the bloodstream.
Read the detailed description
Objective The primary objective of this study is to determine the pharmacokinetic profile of a single dose of Nicotine Sublingual Tablets, 4 mg (Test Product) versus Nicorette Lozenge 4 mg in healthy adult smokers when administered under fasted conditions.
Study Design This is an open-label, pseudorandomized, two-way crossover comparison of the 4 mg sublingual nicotine tablet versus the Nicorette Lozenge 4 mg.
Number of Subjects Twenty-four (24) healthy adult smokers will be enrolled. Screening Procedures Demographic data, medical and medication histories, physical examination, measurement of height and weight, electrocardiogram (ECG), vital signs (blood pressure, heart rate, body temperature and respiratory rate), hematology, chemistry, urinalysis, end-expired Carbon Monoxide, and serum pregnancy test (for female subjects only) .
Confinements Subjects will be confined approximately 2 hours or earlier prior to study drug administration until after discharge vital signs and the 240 minute (min) post-dose blood draw and End-of-Study (EOS) procedures.
Study Drug Administration A single dose of Test Product (Nicotine Sublingual Tablets, 4 mg) and Nicorette Lozenge 4 mg will be administered to each subject in the study.
Sample Collection A total of 14 blood samples will be obtained per period. Samples will be taken pre-dose (up to 90 minutes prior to dose) and 3, 6, 9, 12, 15, 20 30, 45, 60, 90, 120, 180 and 240 minutes post-dose. A minimum of 48 hours will transpire between dose administrations.
Safety Assessments Vital signs (blood pressure, heart rate, body temperature and respiratory rate) will be measured before administration of study drug. The following will be performed at check-in: urine pregnancy test (for female subjects only). Ongoing monitoring for adverse events (AEs) will be performed during the study. Prior to release from the clinic, a well-being assessment and discharge vital signs will be completed 240 minutes (±60 min) post dosing or at Early Termination (ET).
End of Study (EOS) or Early Termination (ET) Procedures Vital signs and monitoring for AEs will be done 240 min post-dosing or at ET/withdrawal prior to release from clinic.
Analytical Method Plasma concentrations of nicotine will be determined using a validated liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) method.
Pharmacokinetics/Pharmacodynamics Determination of primary parameters Area under the curve ( AUC0-t, AUC0-inf), concentration maximum (Cmax), Time to maximum concentration(Tmax) and secondary parameters such as plasma elimination half-life( t1/2) using a by non-linear kinetics program (WinNonlin®). Pharmacodynamics effects will be measured by taking the heart rate and blood pressure will be taken three times in the first 30 minutes after test product administration. A craving assessment will be obtained at 1, 3, 7, 11, and 14 minutes post-medication administration.
Statistical Analyses No formal statistical analyses are planned; descriptive statistics of the concentration and pharmacokinetic data on nicotine will be provided. Exploratory analyses of craving reductions will be conducted.
- Conditions
- Tobacco Use Disorder, Cigarette Smoking
- Being tested
- Sublingual tablet 4 mg versus Nicorette Lozenge 4mg
- Keywords
- pharmacokinetics, nicotine absorption
- Medical subject headings
- Tobacco Use Disorder, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sublingual tablet 4 mg versus Nicorette Lozenge 4mgDrug
Also called Pharmacokinetic comparison of two nicotine dosage forms
- One dose of study drug (sublingual tablet or Nicorette Lozenge) will be administered to each subject in the morning on Day 1.
- The second administration of drug will occur at least 48 hours after the initial administration. Subjects will receive the other dosage form and be instructed according to whether they are receiving the sublingual tablet or the lozenge.
| Study group | Role | What they receive |
|---|---|---|
| Sublingual tablet 4 mg | Experimental | The 24 study participants will be administered the sublingual 4 mg nicotine tablet on one occasion. Blood samples will be obtained for 4 hours for analysis of nicotine plasma levels. Receives: Drug: Sublingual tablet 4 mg versus Nicorette Lozenge 4mg |
| Nicorette lozenge 4 mg | Active comparator | The 24 study participants will be administered the Nicorette lozenge containing 4 mg of nicotine on one occasion. Blood samples will be obtained for 4 hours for analysis of nicotine plasma levels. Receives: Drug: Sublingual tablet 4 mg versus Nicorette Lozenge 4mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time course profile of nicotine absorption from the two nicotine dosage forms.
Measured: Fourteen blood samples will be collected over a 240 minute period after drug administration.
Secondary outcomes (2)
Assessment of craving for a cigarette
Five questions about desire to smoke will be assessed using visual analog scales at the time points above.
Measured: The craving assessment will be obtained at 1, 3, 7, 11,and 14 minutes after drug administration
Safety assessments: Vital signs
Measured: Vital signs will be measured prior to drug administration, 3 times in the first 30 minutes, and prior to discharge at 240 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study start25 May 2017
- Primary completion27 Nov 2017
- Study completion27 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Friends Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Rose Research Center, LLC
- Responsible party
- Sponsor
- Investigators
- Frank J Vocci, Ph.D., Principal investigator, Friends Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906995
- Sponsor's protocol ID
- 16-07-239
- Status last verified
- Dec 2017
- First submitted
- 15 Sep 2016
- Last updated
- 4 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual data may be shared with investigators who send the PI a data analysis plan.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Pseudorandomized, Two Way Crossover Comparison of the Single-Dose Pharmacokinetics of Nicotine 4 mg Sublingual Tablets Versus Nicorette Lozenge 4 mg in Healthy Smokers Under Fasted Conditions
- ClinicalTrials.gov ID
- NCT02906995
- Acronym / sponsor ID
- 16-07-239
- Conditions
- Tobacco Use Disorder, Cigarette Smoking
- Keywords
- pharmacokinetics, nicotine absorption
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Friends Research Institute, Inc.University, hospital or other
- Collaborators
- Rose Research Center, LLC
- Study start
- 25 May 2017 (actual)
- Primary completion
- 27 Nov 2017 (actual)
- Study completion
- 27 Nov 2017 (actual)
- First posted
- 20 Sep 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 the study is to compare two different dosage forms from which nicotine is released and absorbed into the bloodstream.
Detailed description
Objective The primary objective of this study is to determine the pharmacokinetic profile of a single dose of Nicotine Sublingual Tablets, 4 mg (Test Product) versus Nicorette Lozenge 4 mg in healthy adult smokers when administered under fasted conditions.
Study Design This is an open-label, pseudorandomized, two-way crossover comparison of the 4 mg sublingual nicotine tablet versus the Nicorette Lozenge 4 mg.
Number of Subjects Twenty-four (24) healthy adult smokers will be enrolled. Screening Procedures Demographic data, medical and medication histories, physical examination, measurement of height and weight, electrocardiogram (ECG), vital signs (blood pressure, heart rate, body temperature and respiratory rate), hematology, chemistry, urinalysis, end-expired Carbon Monoxide, and serum pregnancy test (for female subjects only) .
Confinements Subjects will be confined approximately 2 hours or earlier prior to study drug administration until after discharge vital signs and the 240 minute (min) post-dose blood draw and End-of-Study (EOS) procedures.
Study Drug Administration A single dose of Test Product (Nicotine Sublingual Tablets, 4 mg) and Nicorette Lozenge 4 mg will be administered to each subject in the study.
Sample Collection A total of 14 blood samples will be obtained per period. Samples will be taken pre-dose (up to 90 minutes prior to dose) and 3, 6, 9, 12, 15, 20 30, 45, 60, 90, 120, 180 and 240 minutes post-dose. A minimum of 48 hours will transpire between dose administrations.
Safety Assessments Vital signs (blood pressure, heart rate, body temperature and respiratory rate) will be measured before administration of study drug. The following will be performed at check-in: urine pregnancy test (for female subjects only). Ongoing monitoring for adverse events (AEs) will be performed during the study. Prior to release from the clinic, a well-being assessment and discharge vital signs will be completed 240 minutes (±60 min) post dosing or at Early Termination (ET).
End of Study (EOS) or Early Termination (ET) Procedures Vital signs and monitoring for AEs will be done 240 min post-dosing or at ET/withdrawal prior to release from clinic.
Analytical Method Plasma concentrations of nicotine will be determined using a validated liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) method.
Pharmacokinetics/Pharmacodynamics Determination of primary parameters Area under the curve ( AUC0-t, AUC0-inf), concentration maximum (Cmax), Time to maximum concentration(Tmax) and secondary parameters such as plasma elimination half-life( t1/2) using a by non-linear kinetics program (WinNonlin®). Pharmacodynamics effects will be measured by taking the heart rate and blood pressure will be taken three times in the first 30 minutes after test product administration. A craving assessment will be obtained at 1, 3, 7, 11, and 14 minutes post-medication administration.
Statistical Analyses No formal statistical analyses are planned; descriptive statistics of the concentration and pharmacokinetic data on nicotine will be provided. Exploratory analyses of craving reductions will be conducted.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sublingual tablet 4 mg | Experimental | Drug: Sublingual tablet 4 mg versus Nicorette Lozenge 4mgThe 24 study participants will be administered the sublingual 4 mg nicotine tablet on one occasion. Blood samples will be obtained for 4 hours for analysis of nicotine plasma levels. |
| Nicorette lozenge 4 mg | Active comparator | Drug: Sublingual tablet 4 mg versus Nicorette Lozenge 4mgThe 24 study participants will be administered the Nicorette lozenge containing 4 mg of nicotine on one occasion. Blood samples will be obtained for 4 hours for analysis of nicotine plasma levels. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participants have to be 18-45 years old
- Participants must provide written informed consent prior to any study related procedures being performed.
- Participants must have a willingness and ability to comply with the protocol requirements.
- Participants must be in good health and free from any clinically significant pathology (gastrointestinal tract, hepatic, renal, cardiovascular, CNS diseases)
- Female participants of childbearing potential, in addition to having a negative urine pregnancy test, must be willing to use a form of birth control during the study. The hormonal contraceptives should be avoided within 2 month prior to study entry.
Key exclusion criteria (15 listed)
- Volunteers that have used other nicotine delivery system such as nicotine lozenge, nicotine patch, nicotine inhaler, or nicotine nasal spray etc within 30 days of study entry.
- Volunteers who have currently involved in another clinical trial or have used any investigational drug within 3 month of study entry.
- Volunteers who are pregnant or lactating, or plan to become pregnant within 6 months.
- Volunteers who have diagnosed heart disease or are being treated with medication or had an irregular heartbeat or have had a myocardial infarction.
- Volunteers with diagnosed stomach ulcers.
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 tablet 4 mg versus Nicorette Lozenge 4mgAlso: Pharmacokinetic comparison of two nicotine dosage forms* One dose of study drug (sublingual tablet or Nicorette Lozenge) will be administered to each subject in the morning on Day 1. * The second administration of drug will occur at least 48 hours after the initial administration. Subjects will receive the other dosage form and be instructed according to whether they are receiving the sublingual tablet or the lozenge. | Drug | Nicorette lozenge 4 mg, Sublingual tablet 4 mg |
Primary outcome
the time course profile of nicotine absorption from the two nicotine dosage forms.
Time frame: Fourteen blood samples will be collected over a 240 minute period after drug administration.
2 secondary outcomes
Assessment of craving for a cigarette
Time frame: The craving assessment will be obtained at 1, 3, 7, 11,and 14 minutes after drug administration
Safety assessments: Vital signs
Time frame: Vital signs will be measured prior to drug administration, 3 times in the first 30 minutes, and prior to discharge at 240 minutes.
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 4 Dec 2017.
- Individual participant dataSharing planned: Yes. De-identified individual data may be shared with investigators who send the PI a data analysis plan.
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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.
Frank J Vocci, Ph.D. principal investigator
Friends Research Institute, Inc.
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 Sublingual tablet 4 mg versus Nicorette Lozenge 4mg in people with Tobacco Use Disorder and Cigarette Smoking, run by Friends Research Institute, Inc. at 1 site in United States.
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 7 inclusion and 15 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 4 Dec 2017. 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 United States. 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?
the time course profile of nicotine absorption from the two nicotine dosage forms. (time frame: Fourteen blood samples will be collected over a 240 minute period after drug 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 4 Dec 2017.