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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 is a Early Phase 1 study that has completed, run by Yale University. The registered enrollment target is 34 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01495819
The ClinicalTrials.gov registry entry for NCT01495819 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 34 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 2 interventions - of which Saline is the first listed.
NCT01495819 reports 0 study locations.
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.
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