Effect of Galantamine on Smoking Abstinence

Status Completed

Clinical Trial 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.

Clinical Trial Description

Galantamine, an FDA-approved treatment for Alzheimer's disease, is used to treat cognitive impairment by enhancing acetylcholine through inhibition of the enzyme, acetylcholinesterase. We propose an open-label pilot feasibility study of short-term (6 weeks) treatment with galantamine.

Sixteen chronic smokers will undergo a validated procedure for screening new medications. Following an initial 4-week drug run-up phase (8mg daily of galantamine-ER), medication dose will be increased to 16 mg daily of galantamine-ER during the fifth and sixth weeks of the study. At the beginning of Week 6, smokers will receive brief counseling and make a 7-day quit attempt.

Following completion of the study, participants will be offered standard smoking cessation treatment. Subjects will perform a working memory task (Visual/Spatial N-Back), a sustained attention task (Continuous Performance Task; CPT), a recall memory task (Word Recognition), a cognitive flexibility task (Wisconsin Card Sort Test), and a response inhibition task (Stop Signal Task). The primary outcome is the ability to remain abstinent during a 7-day quit attempt. Secondary outcomes include change in cognitive performance, adherence, and side effects.

This pilot study will provide information about the role of the cholinergic system during brief abstinence and whether enhancing acetylcholine reduces abstinence-induced cognitive symptoms that promote smoking relapse. Information obtained in this study may further establish cognitive performance measures as endophenotypes for nicotine dependence. ;

Study Design

Related Conditions & MeSH terms

Nicotine Addiction

Clinical Trial Details

NCT number	NCT01548638
Study type	Interventional
Source	University of Pennsylvania
Contact
Status	Completed
Phase	Phase 2
Start date	February 2012
Completion date	October 2013

View Details

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