Transdermal Patch CVD 1000: The Effect of Heat on Nicotine Release From Nicotine Patches in Adult Smokers
Condition: Smoking
Intervention: Nicoderm patch first, then Aveva patch
Intervention description: 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).
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Intervention 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)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Therapeutic Equivalency

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

          -  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.

        Exclusion Criteria:

          -  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

               -  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:

               1. Thrombophlebitis, thromboembolic disorders

               2. A past history of deep vein thrombophlebitis or thromboembolic disorders

               3. Cerebrovascular or coronary artery disease (current or past history)

               4. Valvular heart disease with complications

               5. Severe hypertension

               6. Diabetes with vascular involvement

               7. Headaches with focal neurological symptoms

               8. 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.