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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: Completed Phase 1 study of Smoking and Tobacco Withdrawal, sponsored by Yale University.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

Urine sample and blood samples anticipated for 24 male and females

Interventions

  • DRUG Galantamine
  • DRUG IV Nicotine

Study Locations (1)

Connecticut

  • Department of Veterans Affairs - West Haven

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2010-03
Est. Completion 2011-03
Phase Phase 1
Yale University

1,492 total trials

What the finished NCT01417429 record still lists

NCT01417429 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 455-participant average among 123 other Smoking trials with a reported enrollment target (97% lower).

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 a single indexed study location in 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.

Similar trials for Smoking

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01417429's enrollment target sits among peer trials

12 122nd of 123 higher than 2 of 123 other Smoking trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Smoking 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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Source: ClinicalTrials.gov NCT01417429, the US trial registry maintained by the National Library of Medicine. NCT01417429 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.