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

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Treatments: Galantamine; Nicotine

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.