Effect of Galantamine on Short-term Abstinence

Status Completed

Clinical Trial Summary

This is a randomized, double-blind, placebo-controlled study to test 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 randomized double-blind placebo-controlled study of short-term (23 days) treatment with galantamine.

Eighty chronic smokers will complete a validated procedure for screening new medications. An equal number of subjects will be assigned to one of two groups: galantamine-ER or placebo. Participants in both groups will take one capsule each day and follow the same procedures. This is not a cross-over trial.

For participants in the galantamine group, following an initial 1-week drug run-up phase (8mg daily of galantamine-ER), the medication dose will be increased to 16mg daily of galantamine-ER for the remainder of the study (up to Day 23).

On Day 15, smokers will begin a mandatory 24-hour abstinence period, which will be followed by a programmed smoking lapse on Day 16. Smokers will then be instructed to abstain for the following 7 days (observed abstinence). Following completion of the study, participants will be offered standard smoking cessation treatment.

On Days 0 (Baseline), 14, and 16, subjects will perform the following computer tasks: a working memory task (Visual/Spatial N-Back), sustained attention tasks (Penn Continuous Performance Task [PCPT-nl] and XO Reaction Time Task), a recall memory task (Word Recognition), an interference control task (Stroop test), and a response inhibition task (Stop Signal Task).

The primary outcome is to identify changes in behavioral performance and subjective symptoms following two weeks treatment of galantamine and after 24 hours of abstinence, compared to baseline.

This 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

Tobacco Use Disorder

Clinical Trial Details

NCT number	NCT01669538
Study type	Interventional
Source	University of Pennsylvania
Contact
Status	Completed
Phase	Phase 2
Start date	August 2012
Completion date	November 2017

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effect of Galantamine on Short-term Abstinence — GAL-K

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms