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NCT01417429 · ClinicalTrials.gov registry record · Phase 1
Galantamine Effects on Nicotine Responses in Smokers
A Phase 1 study of Smoking and Tobacco Withdrawal, sponsored by Yale University.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT01417429 is a Phase 1 study of Smoking and Tobacco Withdrawal that has completed, run by Yale University. The registered enrollment target is 12 participants, below the 455-participant average among 123 other Smoking trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01417429, a Phase 1 study of Smoking and Tobacco Withdrawal, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This will be a 2-4 week double-blind, placebo-controlled study. Twenty four male and female smokers will first have two 4-day treatment periods, in which they will be randomized to galantamine (8 mg/day) or placebo. These treatment periods will be separated by a 3 to 14 day washout period. During the first 3-days of each treatment period, smokers will have daily clinic visits, where they will receive study medications and any adverse effects from study medications will be monitored. Starting at 10 p.m. on Day 1 of each treatment period, subjects will refrain from smoking for approximately 2.5 days, until the experimental session on Day 4. Compliance with non-smoking will be verified by CO levels \< 10 ppm. During the experimental sessions, subjects will receive saline or 1.0 mg/70 kg of nicotine intravenously in a random, double-blind manner. The sequence of nicotine treatments will be counterbalanced among subjects such that equal number of subjects will receive saline first or nicotine first. Following each saline and nicotine treatments, physiological, subjective and cognitive measurements will be obtained
Conditions Studied
Interventions
- DRUG Galantamine
- DRUG IV Nicotine
Study Locations (1)
Connecticut
- Department of Veterans Affairs - West Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2010-03 |
| Est. Completion | 2011-03 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01417429
The ClinicalTrials.gov registry entry for NCT01417429 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 455-participant average among 123 other Smoking trials with a reported enrollment target (97% lower). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Smoking appearing as the primary indexed condition, and to 2 interventions - of which Galantamine is the first listed.
NCT01417429 reports 1 study location spanning 1 distinct geographic area - top geographies include Connecticut.
Frequently Asked Questions
What is clinical trial NCT01417429 about?
NCT01417429 is a clinical study titled "Galantamine Effects on Nicotine Responses in Smokers". This will be a 2-4 week double-blind, placebo-controlled study. Twenty four male and female smokers will first have two 4-day treatment periods, in which they will be randomized to galantamine (8 mg/day) or placebo. These treatment periods will be separated by a 3 to 14 day washout period. During th...
What is the current status of trial NCT01417429?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2010-03. Estimated completion is 2011-03.
What conditions does trial NCT01417429 study?
This clinical trial studies the following conditions: Smoking, Tobacco Withdrawal.
What interventions are being tested in trial NCT01417429?
The interventions under investigation include: Galantamine (DRUG), IV Nicotine (DRUG).
Who is sponsoring clinical trial NCT01417429?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01417429 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.