SmokingPhase 4NCT02371850
Transdermal Patch CVD 1000: The Effect of Heat on Nicotine Release From Nicotine Patches in Adult Smokers
A Phase 4 study testing Nicoderm patch first, then Aveva patch in people with Smoking, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
This is a single-dose, Open-label, Non-Randomized, 2-way Crossover Bioequivalence Study to compare nicotine release after heating of a brand name (Nicoderm CQ) and generic (Aveva skin patch) nicotine skin patches in adult smokers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Nicoderm patch first, then Aveva patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Jun 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 1. Men or non-pregnant women of any ethnic background between the age of 18 and 45 years old
- 2. Subjects should be cigarette smokers who smoke at least 5 cigarettes per day for one year or more.
- 3. Provide written informed consent before initiation of any study procedures.
- 4. Available for follow-up for the planned duration of the study
- 5. Able to communicate well with the investigators
- 6. Able to adhere to the study restrictions and examination schedule.
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- 7. Subjects who are within their ideal body weight (BMI >17 and <= 25)
- 8. Demonstrate comprehension of the protocol procedures and knowledge of study by passing (>70% correct responses) a written examination containing 20 multiple choice and true false questions covering all aspects of the study including the purpose, procedures, risks and benefits.
- 9. Subjects deemed to be eligible as judged by the Medically Accountable Investigator (MAI) and determined by medical history, physical examination, and medication history.
- 10. Have a normal blood pressure (systolic: 90-140 mmHg; diastolic: 50-90 mmHg) and heart rate (55-100 bpm),
- 11. Have normal screening laboratories for WBC, Hgb, platelets, sodium, potassium, chloride, bicarbonate, BUN, creatinine, ALT and AST
- 12. Have normal screening laboratories for urine protein and urine glucose.
- 13. Female subjects must be of non-childbearing potential (as defined as surgically sterile [i.e. history of hysterectomy or tubal ligation] or postmenopausal for more than 1 year), or if of childbearing potential, must be non-pregnant at the time of enrollment and on the morning of each procedure day, and must agree to use hormonal or barrier birth control such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner.
- 14. Agrees not to participate in another clinical study during the study period.
- 15. Agrees not to donate blood to a blood bank throughout participation in the study and for at least 3 months after last procedure day.
- 16. Have a normal ECG
- 17. Be a smoker willing to refrain from smoking 10 hours prior to, and during, each procedure day of the study.
Who cannot join
- 1. Subjects who are nonsmokers or smoke less than 5 cigarettes per day
- 2. Women who are pregnant or lactating or have a positive serum pregnancy test at enrollment or on the morning of any procedure day.
- 3. Participation in any ongoing investigational drug trial or clinical drug trial
- 4. Abnormal Vital signs, defined as:
- Hypertension (systolic blood pressure >140 mm Hg or diastolic blood pressure >90 mm Hg) at rest on 2 separate days)
- Heart rate <55 at rest on 2 separate days
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- Respiratory rate >20
- 5. Temperature > 38.0 ºC (100.4 ºF) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within 7 days of administration of the transdermal patch.
- 6. Active positive Hepatitis B, C, and HIV serologies
- 7. Positive urine drug screening test
- 8. Use of any prescription medication during the period 0 to 30 days or over-the counter medication (vitamin, herbal supplements and birth control medications not included) during the period 0 to 5 days before entry to the study
- 9. Donation or loss of greater than one pint of blood within 60 days of entry to the study
- 10. Any prior serious adverse reaction or hypersensitivity to nicotine or any of the inactive ingredients in the patch (acrylate adhesive, polyester, silicone, ethylene vinyl acetate-copolymer polyisobutylene and polyethylene)
- 11. Have a diagnosis of schizophrenia or other major psychiatric diagnosis.
- 12. Received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month before enrollment in this study or expects to receive an experimental agent during the study.
- 13. Any condition that would, in the opinion of the Medically Accountable Investigator (MAI), place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
- 14. Inability to communicate or co-operate with the investigators
- 15. History of consumption of alcohol within 24 hours prior to dose administration
- 16. Scarring on upper arms, including tattoos at planned site of patch placement making skin reactions not evaluable
- 17. Subject who currently has any of the following conditions:
- Thrombophlebitis, thromboembolic disorders
- A past history of deep vein thrombophlebitis or thromboembolic disorders
- Cerebrovascular or coronary artery disease (current or past history)
- Valvular heart disease with complications
- Severe hypertension
- Diabetes with vascular involvement
- Headaches with focal neurological symptoms
- Major surgery with prolonged immobilization
- 18. Medical history of a serious chronic condition (e.g. allergic conditions such as anaphylaxis, asthma or generalized drug reaction).
- 19. Medical history of significant dermatologic diseases or conditions, such as atopy, psoriasis, vitiligo or conditions known to alter skin appearance or physiologic response (e.g. diabetes, porphyria).
- 20. History of significant dermatologic cancers (e.g. melanoma, squamous cell carcinoma), except basal cell carcinomas that were superficial and did not involve the investigative site.
- 21. Within 10 hours prior to dosing, use of other nicotine products (e.g. nicotine gum or other nicotine-containing products) that would significantly influence or exaggerate responses to the nicotine patches used in this study.
- 22. Within 72 hours prior to dosing, use of antihistamines or use of topical drugs at patch site.
- 23. Subject has an obvious difference in skin color between arms or the presence of a skin condition, open sores, scar tissue, tattoo, or coloration that would interfere with placement of test articles, skin assessment, or reactions to drug.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, Baltimore Center for Vaccine Development
Baltimore, Maryland, 21201
About this study
Official title: Determination of Plasma Nicotine Levels After Using Reference and Generic Transdermal Nicotine Patches With and Without Standardized Heat Application in Adult Smokers
This is a single-dose, Open-label, Non-Randomized, 2-way Crossover Bioequivalence Study to compare nicotine release after heating of a brand name (Nicoderm CQ) and generic (Aveva skin patch) nicotine skin patches in adult smokers.
Read the detailed description
This research study is intended to determine the effect of heat on FDA-approved nicotine transdermal patches and whether the heat applied will result in more nicotine being absorbed through the skin than without applying heat. This is important given that little is known about how the release of nicotine is affected by heat, particularly for generic products that are also available over the counter. This study will use nicotine patches (brand name and generic patches) that have been approved by the Food and Drug Administration (FDA) and are already sold over the counter to customers in the United States, and will not include any placebos.
- Conditions
- Smoking
- Being tested
- Nicoderm patch first, then Aveva patch
- Keywords
- Bioequivalence, Therapeutic Equivalency
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicoderm patch first, then Aveva patchDrug
Also called Brand name nicotine patch first, then generic nicotine patch
This is a single group assignment where each of 10 adult smokers completes 4 procedure days using a Nicoderm CQ nicotine patch (2 days) followed by the application of a generic Aveva patch (2 days). For each patch, heating is applied for one hour at hour 4 on the first procedure day and at hour 8 in the second procedure day (2 days per patch, or a total of 4 days per subject).
| Study group | Role | What they receive |
|---|---|---|
| Nicoderm patch first, then Aveva patch | Experimental | Each subject gets two procedure days with heating applied for one hour at hours 4 and hour 8 after the application of the Nicoderm CQ nicotine patch, then followed by two procedure days with heating applied for one hour at hours 4 and hour 8, after the application of the Aveva nicotine patch (total of four Procedure days) Receives: Drug: Nicoderm patch first, then Aveva patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Maximum Serum Concentration (Cmax)
The main outcome measure of the study is the measurement of maximum serum concentration (Cmax)
Measured: four procedure days for each participant
Secondary outcomes (1)
AUC
(area under the concentration-time curve of nicotine 0-12 h)
Measured: 0-12 h for each of the four procedure day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startOct 2014
- Primary completionApr 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each subjects gets two procedure days with heating applied for one hour at hours 4 and hour 8 after the application of the Nicoderm CQ nicotine patch, then followed by two procedure days with heating applied for one hour at hours 4 and hour 8, after the application of the Aveva nicotine patch (total of four Procedure days)
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Responsible party
- Principal investigator, Audra Stinchcomb, University of Maryland, Baltimore
- Investigators
- Samer El-Kamary, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371850
- Sponsor's protocol ID
- HP-00059146
- Status last verified
- Jun 2021
- First submitted
- 6 Feb 2015
- Last updated
- 16 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: IPD will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Plasma Nicotine Levels After Using Reference and Generic Transdermal Nicotine Patches With and Without Standardized Heat Application in Adult Smokers
- ClinicalTrials.gov ID
- NCT02371850
- Acronym / sponsor ID
- HP-00059146
- Conditions
- Smoking
- Keywords
- Bioequivalence, Therapeutic Equivalency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Study start
- Oct 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 26 Feb 2015 (estimated)
- Results
- Posted 17 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-dose, Open-label, Non-Randomized, 2-way Crossover Bioequivalence Study to compare nicotine release after heating of a brand name (Nicoderm CQ) and generic (Aveva skin patch) nicotine skin patches in adult smokers.
Detailed description
This research study is intended to determine the effect of heat on FDA-approved nicotine transdermal patches and whether the heat applied will result in more nicotine being absorbed through the skin than without applying heat. This is important given that little is known about how the release of nicotine is affected by heat, particularly for generic products that are also available over the counter. This study will use nicotine patches (brand name and generic patches) that have been approved by the Food and Drug Administration (FDA) and are already sold over the counter to customers in the United States, and will not include any placebos.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each subjects gets two procedure days with heating applied for one hour at hours 4 and hour 8 after the application of the Nicoderm CQ nicotine patch, then followed by two procedure days with heating applied for one hour at hours 4 and hour 8, after the application of the Aveva nicotine patch (total of four Procedure days)
| Arm | Type | Receives |
|---|---|---|
| Nicoderm patch first, then Aveva patch | Experimental | Drug: Nicoderm patch first, then Aveva patchEach subject gets two procedure days with heating applied for one hour at hours 4 and hour 8 after the application of the Nicoderm CQ nicotine patch, then followed by two procedure days with heating applied for one hour at hours 4 and hour 8, after the application of the Aveva nicotine patch (total of four Procedure days) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- 1. Men or non-pregnant women of any ethnic background between the age of 18 and 45 years old
- 2. Subjects should be cigarette smokers who smoke at least 5 cigarettes per day for one year or more.
- 3. Provide written informed consent before initiation of any study procedures.
- 4. Available for follow-up for the planned duration of the study
- 5. Able to communicate well with the investigators
Key exclusion criteria (34 listed)
- 1. Subjects who are nonsmokers or smoke less than 5 cigarettes per day
- 2. Women who are pregnant or lactating or have a positive serum pregnancy test at enrollment or on the morning of any procedure day.
- 3. Participation in any ongoing investigational drug trial or clinical drug trial
- 4. Abnormal Vital signs, defined as:
- 5. Temperature > 38.0 ºC (100.4 ºF) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within 7 days of administration of the transdermal patch.
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 |
|---|---|---|
| Nicoderm patch first, then Aveva patchAlso: Brand name nicotine patch first, then generic nicotine patchThis is a single group assignment where each of 10 adult smokers completes 4 procedure days using a Nicoderm CQ nicotine patch (2 days) followed by the application of a generic Aveva patch (2 days). For each patch, heating is applied for one hour at hour 4 on the first procedure day and at hour 8 in the second procedure day (2 days per patch, or a total of 4 days per subject). | Drug | Nicoderm patch first, then Aveva patch |
Primary outcome
Measurement of Maximum Serum Concentration (Cmax)
Time frame: four procedure days for each participant
The main outcome measure of the study is the measurement of maximum serum concentration (Cmax)
1 secondary outcome
AUC
Time frame: 0-12 h for each of the four procedure day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. IPD will not be shared
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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.
Samer El-Kamary, MD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicoderm patch first, then Aveva patch in people with Smoking, run by University of Maryland, Baltimore 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 17 inclusion and 34 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 16 Jun 2021. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Measurement of Maximum Serum Concentration (Cmax) (time frame: four procedure days for each participant). 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 16 Jun 2021.