Galantamine Effects on Cognitive Function in Abstinent Cocaine Users

Yale University

Status

Completed

Conditions

Cocaine Abuse

Treatments

Drug: placebo

Drug: Galantamine

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00606801

0706002768

B Rounsaville (Other Identifier)

P50DA009241 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

To evaluate galantamine's effects on cognitive performance in abstinent cocaine users. Galantamine, a medication approved for treatment of Alzheimer's disease, is an acetylcholine esterase inhibitor. Galantamine also directly potentiates nicotine receptors. Both of these effects may result in improved cognitive performance in a group of subjects known to have impaired performance in various cognitive tasks.

Full description

Galantamine, compared to placebo, will improve cognitive performance in abstinent cocaine users. The cognitive performance will be measured with the Stroop test and 3 Cambridge Neuropsychological Test Automated Battery (CANTAB) tests: Paired Associate Learning (PAL), Delayed Pattern Recognition Memory (PRM),and Rapid Visual Information Processing (RVIP). Performance on these tests has been shown to be impaired in abstinent cocaine users, compared to healthy controls.

Galantamine, compared to placebo, will not be associated with any significant changes in mood. Monitoring of mood will be achieved with 3 mood scales: 1) Center for Epidemiologic Studies Depression (CES-D) scale, Positive and Negative Affect Schedule (PANAS) and the Profile of Mood States (POMS).

Currently this study is completed, Patients are no longer being enrolled. There were 28 completers. This study has been published.

Enrollment

34 patients

Sex

All

Ages

21 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male and females, between the ages 21 and 50
Fulfill criteria for past cocaine dependence
No cocaine use for the past 30 days
No other current dependence or abuse of other drugs or alcohol
No current medical problems and normal ECG
Not pregnant,nor breast feeding,
Using acceptable birth control methods.

Exclusion criteria

Current major psychiatric illness including mood, psychotic or anxiety disorders
History of major medical illnesses; including asthma or chronic obstructive lung disease, history or current gastrointestinal ulcer, hepatic or renal impairment and cardiac rhythm disturbances
Use of other medications including,drugs that slow heart rate
Known allergy to galantamine