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

NCT ID: NCT02420327

Last Updated: 2019-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2017-03-31

Brief 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.

Detailed Description

Healthy non-smokers will be screened for study eligibility and receive training on three different attention tasks. Over four test session, participants will then perform these tasks after receiving (1) a placebo patch and a placebo capsule, (2) a nicotine patch (7 mg/24 hrs) and a placebo capsule, (3) a placebo patch and a galantamine capsule, and (4) a nicotine patch and a galantamine capsule. The four test session are performed on separate days and take approximately 7 hours each. During the first 5 hours, the participant may read or watch TV while nicotine and/or galantamine are being absorbed. During the last two hours, the participant will perform the attention tasks on a computer. The investigators hypothesize that performance-enhancing effects of nicotine, which were documented in previous research, will be larger in the presence than in the absence of galantamine. This proof-of-concept would have implications for the development of drugs for the treatment of conditions such as Alzheimer's disease or schizophrenia.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Placebo patch and placebo capsule

On the double-placebo test day, participants receive a placebo patch and a placebo capsule.

Group Type: EXPERIMENTAL

Placebo patch & placebo capsule

Intervention Type: DRUG

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

Nicotine patch and placebo capsule

On the nicotine test day, participants receive a nicotine patch (7 mg/24 hrs) and a placebo capsule.

Group Type: EXPERIMENTAL

Nicotine patch & placebo capsule

Intervention Type: DRUG

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

Placebo patch and galantamine capsule

On the galantamine test day, participants receive a placebo patch and a capsule containing 4 mg of galantamine.

Group Type: EXPERIMENTAL

Placebo patch & galantamine capsule

Intervention Type: DRUG

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

Nicotine patch and galantamine capsule

On the nicotine + galantamine test day, participants receive a nicotine patch (7 mg/24 hrs) and a capsule containing 4 mg of galantamine.

Group Type: EXPERIMENTAL

Nicotine patch and galantamine capsule

Intervention Type: DRUG

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.).

Interventions

Placebo patch & placebo capsule

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

Intervention Type: 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.).

Intervention Type: 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.

Intervention Type: 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.).

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Britta Hahn

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Britta Hahn, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

University of Maryland School of Medicine, Maryland Psychiatric Research Center

Catonsville, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HP-00057097

Identifier Type: -

Identifier Source: org_study_id