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

Completed · Not applicable · Has a placebo group

Conditions studied: Basic Science Study of the Mechanisms of Attentional Enhancement by Compounds Acting on the Nicotinic Receptor

In brief

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.

Key facts

Study ID

NCT02420327

Run by

University of Maryland, Baltimore

People needed

43

Starts

2014-09-01

Expected to finish

2017-03-01

Last updated by the study team

2019-11-04

Who can join

Age: 21 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Aged 21 to 55 years.
• No exposure to any nicotine-containing product in the last year.
• Smoked no more that 40 cigarettes, cigars or cigarillos in lifetime.
• Normal or corrected to normal vision (at least 20/80).
• Body weight 110-220 lbs.

You may not qualify if…

• Pregnant or breast-feeding.
• Drug or alcohol abuse or dependence currently or in the last 2 years.
• DSM Axis I mood, anxiety or psychotic disorder.
• Cardiovascular or cerebrovascular disease, such as history of myocardial infarction and ischemia, heart failure, angina, stroke, severe arrhythmias, or EKG abnormalities (Wolf-Parkinson-White syndrome, Complete left bundle branch block, PR interval <120 ms or >200 ms, Prolonged QT interval (corrected) >500 ms, Cardiac arrhythmias as defined by PACs >3 per min or PVCs >1 per min).
• Uncontrolled hypertension (resting systolic BP above 140 or diastolic above 90 mm Hg).
• Hypotension (resting systolic BP below 90 or diastolic below 60).
• Significant kidney or liver impairment.
• Moderate to severe asthma.
• Obstructive pulmonary disease.
• Type I or II diabetes.
• Use of any centrally active medications; any peripherally acting cholinergic medications; cimetidine; ketoconazole; erythromycin; quinidine, or chronic nonsteroidal anti-inflammatory drugs.
• History of or current neurological illnesses, such as stroke, seizure disorders, neurodegenerative diseases, or organic brain syndrome.
• Learning disability, mental retardation, or any other condition that impedes cognition.
• Heart rate <55 bpm.
• Current or history of gastric ulcer disease.
• Any surgeries requiring full anesthesia scheduled within 2 weeks of any of the study test sessions.
• Anemia.
• Inability to perform the Rapid Visual Information Processing Task.

Where it is running

• University of Maryland School of Medicine, Maryland Psychiatric Research Center — Catonsville, Maryland, United States

Full record on ClinicalTrials.gov

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