Overview

Pharmacokinetics of Nicotine Film in Smokers

Status:
Completed
Trial end date:
2017-10-01
Target enrollment:
Participant gender:
Summary
The objective of this study is to test the effect of a range of doses of a novel nicotine film on plasma nicotine levels, expired carbon monoxide and, via a questionnaire, subjective ratings of the film and side effects. The nicotine film is not part of standard of care and is not available in a non-investigational setting. The investigators hypothesize that plasma nicotine levels will be in keeping with those induced by other oral nicotine replacement therapies (NRTs) and by the smoking of a cigarette. Thus, the investigators predict that random delivery of nicotine via the oral film will be safe and well-tolerated by the human subjects.
Phase:
N/A
Details
Lead Sponsor:
Milton S. Hershey Medical Center
Treatments:
Nicotine