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Clinical Trial 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.

Clinical Trial Description

Briefly, this will be a two-part pharmacokinetic study, each part involving 12 participants.

In Part 1, 4 volunteer smokers (both male, and female) each will each abstain from all tobacco/nicotine products for 16 hours before attending the Penn State Clinical Research Center for the measurement of the blood nicotine pharmacokinetic response to a randomly allocated dose of either (a) 0mg, (b) 2mg or (c) 4mg oral nicotine film. A trained nurse will implant an intravenous indwelling catheter in each participant, through which they will provide a baseline blood sample after 16 hours of abstinence, confirmed by an exhaled carbon-monoxide < 6 ppm, and then will place a nicotine film in their mouth and have blood drawn every 10 minutes for the next 60 minutes, and then every 30 minutes for the next 2 hours plus one blood draw one minute after the film dissolves (11 blood draws in all over 3 hours after using the nicotine film). Subjective measures of (a) nicotine withdrawal and craving and (b) potential nicotine effects, including symptoms of nicotine intoxication, will be recorded at scheduled intervals through the study visit, and blood pressure and heart rate will be measured every 30 minutes. The investigators expect to find peak blood nicotine concentrations of around 3-4 ng/ml and 5-6 ng/ml from each of the two active doses of nicotine film, with the peak occurring approximately 30 minutes after film administration, and the level having dropped by at least half by 2 hours later. These peak blood nicotine levels are all within the range that a smoker might obtain after smoking a single cigarette. Upon completion of all blood draws, a trained nurse will remove the catheter and treat the puncture wound. The participant will receive $120 for this visit.

In Part 2, 12 participants will again attend the Penn State Clinical Research Center after 16 hours of abstinence, confirmed by an exhaled carbon monoxide < 12 ppm. On this visit participants will consume repeated doses of nicotine films intended to mimic the patterns of delivery that will be used in smoking cessation study 2 and fMRI study 3. The primary issue here is to determine peak blood nicotine concentrations and safety resulting from (a) the highest dose schedule that could be used in study 2 and 3, (b) the steady state levels produced by repeated administration of the 2mg nicotine film, and (c) to compare the subjective effects to placebo. In order to mimic the most aggressive dosing schedule possible in the "random nicotine" arm of study 2 and 3, the investigators will assess blood nicotine, subjective and basic cardiovascular responses to consuming nicotine film every 3 hours beginning at 8:00 a.m. on the following schedule: 4mg, 4mg, 0mg, 4mg.

All 12 participants will attend after 16 hours nicotine abstinence. 4 subjects each will be randomly allocated to consume 4 films over 12 hours in each of the following orders (a) 0,0,0,0 mg (b) 2,2,2,2 or (c) 4,4,0,4. A blood sample will be drawn at baseline prior to each film administration, and then at 30, 60 and 120 minutes after each film administration as well as one minute after film dissolution (20 blood draws in total), with heart rate and BP being assessed every 30 minutes. Nicotine has a half-life of approximately 2 hours, so the investigators expect that with 3-hourly administration there will not be much build-up of nicotine levels and these levels will be on the low end of the typical levels experienced by smokers every day. The participants will each receive $240 for this visit.

At clinic visits, in addition to providing blood samples for measurement of plasma nicotine concentration, participants will be asked to complete a battery of survey instruments assessing subjective effects (e.g. withdrawal and craving) and physical symptoms (e.g. dizziness and nausea) that could be caused by either nicotine withdrawal or nicotine exposure. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT02239770
Study type Interventional
Source Milton S. Hershey Medical Center
Status Completed
Phase N/A
Start date September 2015
Completion date October 2017

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