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NCT01495819 · ClinicalTrials.gov registry record · Early Phase 1
Nicotine Reinforcement and Aversion in Young Adult Light Smokers
A Early Phase 1 study, sponsored by Yale University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 34
- Enrollment target
NCT01495819: Completed Early Phase 1 study, sponsored by Yale University.
NCT01495819 is a Early Phase 1 study that has completed, run by Yale University. The registered enrollment target is 34 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (36% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01495819, a Early Phase 1 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
The proposed study will examine the threshold for nicotine self-administration (NSA) using five different nicotine doses in young adult male and female non-dependent smokers (light and intermittent smokers or LITS). We propose a double-blind, placebo-controlled study that will enroll 195 individuals, targeting a total of 72 completers (36 male and 36 females). In each of the five experimental sessions, smokers will be randomly assigned to one of the five doses of nicotine (0.0125, 0.025, 0.05, 0.1 and 0.2 mg/70 kg). The highest dose, 0.2 mg/70 kg, corresponds to nicotine delivered by about one or two puffs of a cigarette. At the beginning of each experimental session, smokers will sample the assigned both the nicotine dose for that experimental session, and the placebo (saline) dose, followed by the opportunity to choose between nicotine and placebo for a total of ten choices over a 150-minute period. The main outcomes will be threshold dose (the minimum dose of nicotine that is self-administered more than placebo) and the slope of dose-response for nicotine self-administration (changes in nicotine self-administration per unit change in nicotine dose). We will also collect measures of nicotine intake (cotinine), nicotine clearance (3-hydroxycotinine (3-HC) / cotinine), and self-report drug effects
Primary Outcome
The Drug Effects Questionnaire (DEQ) ratings subscale that measures the pleasurable effects was used. I The minimum score is zero with the maximum score of a 100millimeters. The higher the score means the more pleasurable.
Interventions
- DRUG Saline
- DRUG Nicotine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2017-01-04 |
| Est. Completion | 2020-03-31 |
| Phase | Early Phase 1 |
What the finished NCT01495819 record still lists
NCT01495819 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (36% lower).
The record links to 0 conditions, and to 2 interventions - of which Saline is the first listed.
NCT01495819 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01495819 about?
NCT01495819 is a clinical study titled "Nicotine Reinforcement and Aversion in Young Adult Light Smokers". The proposed study will examine the threshold for nicotine self-administration (NSA) using five different nicotine doses in young adult male and female non-dependent smokers (light and intermittent smokers or LITS). We propose a double-blind, placebo-controlled study that will enroll 195 individuals...
What is the current status of trial NCT01495819?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 34 participants. The study started on 2017-01-04. Estimated completion is 2020-03-31.
What interventions are being tested in trial NCT01495819?
The interventions under investigation include: Saline (DRUG), Nicotine (DRUG).
Who is sponsoring clinical trial NCT01495819?
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 NCT01495819's enrollment target sits among peer trials
34 748th of 2000 higher than 1,238 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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