CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 13 enrolled
Drug / intervention
Galantamine ERdrug
Likely dose
Galantamine ER 8mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01548638
NCT01548638Phase 2Completed
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The Effect of the Acetylcholinesterase Inhibitor, Galantamine, on Short-term Abstinence

University of Pennsylvania·interventional·Posted Mar 8, 2012·Updated Dec 26, 2017

In Brief

A Phase 2 clinical trial evaluating Galantamine ER for Nicotine Addiction. Completed, enrolled 13 participants across 1 site.

Detailed Summary

This is a preliminary open-label study to determine whether a medication called galantamine (Brand Name: Razadyne) will help smokers quit and whether it reduces cognitive problems that smokers experience during a quit attempt.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNicotine Addiction
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 8, 2012
Enrollment StartFeb 1, 2012
Primary CompletionAug 1, 2012
Study CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 14.3 years ago

Interventions

Galantamine ERdrug

The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily. Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER.