Pharmacokinetics of Nicotine Film in Smokers

• Status: Completed
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Milton S. Hershey Medical Center
• Treatments: Nicotine

Criteria

Inclusion Criteria:

1. Aged 18 - 55

2. Smoke >9 cigarettes/day for at least the past 12 months

3. Able to understand and consent to study procedures

4. Able to read and write in English

5. Exhaled Carbon Monoxide <12 ppm at in-person screening

Exclusion Criteria:

1. Unstable or significant medical conditions and conditions such as elevated blood pressure (Systolic >140 mm Hg or diastolic >90mm Hg at baseline), COPD and those that are likely to affect biomarker data such as kidney or liver disease.

2. Individuals with sodium-restricted diet, heart disease, recent heart attack, irregular heartbeat, stomach ulcers, or diabetes as well as those taking prescription medications for depression or asthma as indicated under "Warnings" section on FDA approved NRT Drug Facts Label.

3. More than weekly use in the past 3 months of illegal drugs or prescription drugs that are not being used for medically prescribed purposes or inpatient treatment for these in the past 6 months.

4. Use of non-cigarette nicotine delivery product in the prior week (including cigars, pipes, chew, snus, hookah, electronic cigarette and marijuana mixed with tobacco).

5. Use of an FDA approved cessation medication in past week (any NRT, Chantix, Wellbutrin)

6. Women who are pregnant (verified by urine pregnancy test at visit), trying to become pregnant (not using a medically acceptable form of birth control for at least one month prior to visit i.e., oral contraceptives, intrauterine device, double barrier), or nursing.

7. Uncontrolled serious psychiatric illness or inpatient treatment in the past 6 months.

8. Unwillingness to provide blood samples or history of repeatedly fainting during blood draws

9. Any previous adverse reaction to NRT.

10. Any other condition, serious illness, or situation that would, in the investigator's opinion, make it unlikely that the participant could comply with the study protocol.