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NCT02239770 · ClinicalTrials.gov registry record · NA
Pharmacokinetics of Nicotine Film in Smokers
A NA study, sponsored by Milton S. Hershey Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 24
- Enrollment target
NCT02239770: Completed NA study, sponsored by Milton S. Hershey Medical Center.
NCT02239770 is a NA study that has completed, run by Milton S. Hershey Medical Center. The registered enrollment target is 24 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02239770, a NA study, has completed, sponsored by Milton S. Hershey Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
Study 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.
Primary Outcome
In Phase 1, a trained nurse will implant an intravenous (IV) indwelling catheter in each participant. Participants will place a film containing zero, 2, or 4 mg of nicotine in their mouths and blood will be drawn every 10 minutes thereafter for the next 60 minutes, and then every 30 minutes for the next 2 hours (11 blood draws in all over 3 hours after using the nicotine film). In Phase 2, all 12 participants will receive an IV catheter and randomly allocated to consume 4 films over 12 hours in
Interventions
- DRUG Nicotine Film
- DRUG Placebo Nicotine Film
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2015-09 |
| Est. Completion | 2017-10 |
| Phase | NA |
What the finished NCT02239770 record still lists
NCT02239770 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Nicotine Film is the first listed.
NCT02239770 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02239770 about?
NCT02239770 is a clinical study titled "Pharmacokinetics of Nicotine Film in Smokers". 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...
What is the current status of trial NCT02239770?
This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2015-09. Estimated completion is 2017-10.
What interventions are being tested in trial NCT02239770?
The interventions under investigation include: Nicotine Film (DRUG), Placebo Nicotine Film (DRUG).
Who is sponsoring clinical trial NCT02239770?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02239770's enrollment target sits among peer trials
24 1736th of 2000 higher than 246 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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