Galantamine Effects on Cognitive Function in Abstinent Cocaine Users
To evaluate galantamine's effects on cognitive performance in abstinent cocaine users. Galantamine, approved for treatment of Alzheimer's disease, is an acetylcholine esterase inhibitor. Galantamine also directly potentiates nicotine receptors. Both these effects may result in improved cognitive performance.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Galantamine Effects on Cognitive Function in Abstinent Cocaine Users|
- Improvement in cognitive performances in abstinent cocaine users. [ Time Frame: one year ] [ Designated as safety issue: No ]
- Galantamine also directly potentiates nicotine receptors which may result in improved cognitive performance [ Time Frame: one year ] [ Designated as safety issue: No ]
|Study Start Date:||June 2007|
|Study Completion Date:||February 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Galantamine 8 mg/day
Galantamine 8 mg/day
Placebo Comparator: 2
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 Informatin 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 Currently 22 completers. This study has been published.
|United States, Connecticut|
|Veterans Affairs Hospital|
|West Haven, Connecticut, United States, 06516|
|Principal Investigator:||Mehmet Sofuoglu, M.D., Ph.D.||Yale University Associate Professor|