Transdermal Patch CVD 1000: The Effect of Heat on Nicotine Release From Nicotine Patches in Adult Smokers

NCT02371850 | Completed Phase 4 Results

• 1 other identifier: HP-00059146
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking

Keywords

Bioequivalence; Therapeutic Equivalency

Outcome Measures

Primary Outcomes (1)

• Measurement of Maximum Serum Concentration (Cmax)

  The main outcome measure of the study is the measurement of maximum serum concentration (Cmax)

  four procedure days for each participant

Secondary Outcomes (1)

• AUC

  0-12 h for each of the four procedure day

Study Arms (1)

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)

Drug: Nicoderm patch first, then Aveva patch

Interventions

Nicoderm patch first, then Aveva patch DRUG

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).

Also known as: Brand name nicotine patch first, then generic nicotine patch

Nicoderm patch first, then Aveva patch

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Men or non-pregnant women of any ethnic background between the age of 18 and 45 years old
• \. Subjects should be cigarette smokers who smoke at least 5 cigarettes per day for one year or more.
• \. Provide written informed consent before initiation of any study procedures.
• \. Available for follow-up for the planned duration of the study
• \. Able to communicate well with the investigators
• \. Able to adhere to the study restrictions and examination schedule.
• \. Subjects who are within their ideal body weight (BMI \>17 and \<= 25)
• \. 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.
• \. Subjects deemed to be eligible as judged by the Medically Accountable Investigator (MAI) and determined by medical history, physical examination, and medication history.
• \. Have a normal blood pressure (systolic: 90-140 mmHg; diastolic: 50-90 mmHg) and heart rate (55-100 bpm),
• \. Have normal screening laboratories for WBC, Hgb, platelets, sodium, potassium, chloride, bicarbonate, BUN, creatinine, ALT and AST
• \. Have normal screening laboratories for urine protein and urine glucose.
• \. 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.
• \. Agrees not to participate in another clinical study during the study period.
• \. Agrees not to donate blood to a blood bank throughout participation in the study and for at least 3 months after last procedure day.

You may not qualify if:

• \. Subjects who are nonsmokers or smoke less than 5 cigarettes per day
• \. Women who are pregnant or lactating or have a positive serum pregnancy test at enrollment or on the morning of any procedure day.
• \. Participation in any ongoing investigational drug trial or clinical drug trial
• \. 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
• Respiratory rate \>20
• \. 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.
• \. Active positive Hepatitis B, C, and HIV serologies
• \. Positive urine drug screening test
• \. 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
• \. Donation or loss of greater than one pint of blood within 60 days of entry to the study
• \. 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)
• \. Have a diagnosis of schizophrenia or other major psychiatric diagnosis.
• \. 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Food and Drug Administration (FDA): collaborator

Study Sites (1)

University of Maryland, Baltimore Center for Vaccine Development

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Audra Stinchcomb, PharmD
• Organization: University of Maryland School of Pharmacy

astinchc@rx.umaryland.edu

410-706-2646

Study Officials

• Samer El-Kamary, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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)

Study Record Dates

• First Submitted: February 6, 2015
• First Posted: February 26, 2015
• Study Start: October 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 16, 2021
• Results First Posted: August 17, 2017

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)