Low-Dose Galantamine to Potentiate the Attention-Enhancing Effects of Low-Dose Nicotine

NCT02420327 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2019-11-04

Study results available
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Summary

The aim of this study is to test whether the attention-enhancing effects of low-dose nicotine can be enhanced by the drug galantamine, FDA-approved for the treatment of Alzheimer's disease. This proof-of-principle study is performed in healthy non-smokers and involves two single exposures to a nicotine patch (7 mg/24 hrs) and two single exposures to galantamine (4 mg). The dose of galantamine is substantially lower than the clinical dose range of 16-24 mg/day. The hypothesis is that performance-enhancing effects of nicotine are greater in the presence of this low dose of galantamine.

Conditions

  • Basic Science Study of the Mechanisms of Attentional Enhancement by Compounds Acting on the Nicotinic Receptor

Interventions

DRUG

Placebo patch & placebo capsule

On this test day, cognition is assessed after administration of a placebo patch and a placebo capsule.

DRUG

Placebo patch & galantamine capsule

On this test day, cognition is assessed after administration of a placebo patch and a galantamine capsule (4 mg p.o.).

DRUG

Nicotine patch & placebo capsule

On this test day, cognition is assessed after administration of a nicotine patch (7 mg/24 hrs) and a placebo capsule.

DRUG

Nicotine patch and galantamine capsule

On this test day, cognition is assessed after administration of a nicotine patch (7 mg/24 hrs) and a galantamine capsule (4 mg p.o.).

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Britta Hahn, Ph.D. · University of Maryland, Baltimore

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02420327 on ClinicalTrials.gov