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NCT03134339 · ClinicalTrials.gov registry record · Early Phase 1
The Effect of Nicotine Delivery Rate on Reinforcement
A Early Phase 1 study, sponsored by Yale University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 18
- Enrollment target
NCT03134339: Completed Early Phase 1 study, sponsored by Yale University.
NCT03134339 is a Early Phase 1 study that has completed, run by Yale University. The registered enrollment target is 18 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03134339, a Early Phase 1 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
The dose-effect curve to estimate a threshold delivery rate for reinforcement. The project addresses the FDA Center for Tobacco Products (CTP) interest #1: Nicotine dependence threshold among youth and adults and impact of nicotine reduction on tobacco product use behavior (e.g., topography, compensation, switching, multiple use, initiation, cessation and relapse). IV nicotine, in contrast to ECs, can deliver precise, reproducible dosing, which is necessary for accurately assessing dose-response and threshold effects. The estimated threshold for reinforcement will establish a benchmark for evaluating the addictive potential of ECs and other inhaled nicotine products.
Primary Outcome
The peak change in the intensity of subjective effects as measured by the DEQ
Interventions
- DRUG Nicotine saline 0.00mcg/kg/s
- DRUG Nicotine 0.24 mcg/kg/s
- DRUG Nicotine 0.048 mcg/kg/s
- DRUG Nicotine 0.024 mcg/kg/s
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2017-01-05 |
| Est. Completion | 2018-01-29 |
| Phase | Early Phase 1 |
What the finished NCT03134339 record still lists
NCT03134339 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 4 interventions - of which Nicotine saline 0.00mcg/kg/s is the first listed.
NCT03134339 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03134339 about?
NCT03134339 is a clinical study titled "The Effect of Nicotine Delivery Rate on Reinforcement". The dose-effect curve to estimate a threshold delivery rate for reinforcement. The project addresses the FDA Center for Tobacco Products (CTP) interest #1: Nicotine dependence threshold among youth and adults and impact of nicotine reduction on tobacco product use behavior (e.g., topography, compens...
What is the current status of trial NCT03134339?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 18 participants. The study started on 2017-01-05. Estimated completion is 2018-01-29.
What interventions are being tested in trial NCT03134339?
The interventions under investigation include: Nicotine saline 0.00mcg/kg/s (DRUG), Nicotine 0.24 mcg/kg/s (DRUG), Nicotine 0.048 mcg/kg/s (DRUG), Nicotine 0.024 mcg/kg/s (DRUG).
Who is sponsoring clinical trial NCT03134339?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03134339's enrollment target sits among peer trials
18 1316th of 2000 higher than 651 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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