NCT01548638

Effect of Galantamine on Smoking Abstinence

The Effect of the Acetylcholinesterase Inhibitor, Galantamine, on Short-term Abstinence

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Nicotine Addiction

Interventions

Type	Name	Description
DRUG	Galantamine ER	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.

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-08-01
• Completion: 2013-10-01
• First posted: 2012-03-08
• Last updated: 2017-12-26
• Results posted: 2014-07-02

Locations

1 site across 1 country: United States