NCT02371850

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

Determination of Plasma Nicotine Levels After Using Reference and Generic Transdermal Nicotine Patches With and Without Standardized Heat Application in Adult Smokers

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DRUG	Nicoderm patch first, then Aveva 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).

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-04-01
• Completion: 2015-06-01
• First posted: 2015-02-26
• Last updated: 2021-06-16
• Results posted: 2017-08-17

Locations

1 site across 1 country: United States