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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 is a Early Phase 1 study that has completed, run by Yale University. The registered enrollment target is 18 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03134339
The ClinicalTrials.gov registry entry for NCT03134339 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Nicotine saline 0.00mcg/kg/s is the first listed.
NCT03134339 reports 0 study locations.
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.
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