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Galantamine Effects on Cognitive Function in Abstinent Cocaine Users

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00606801
First received: January 23, 2008
Last updated: April 5, 2011
Last verified: April 2011
History of Changes

January 23, 2008
April 5, 2011
June 2007
February 2009   (final data collection date for primary outcome measure)
Improvement in cognitive performances in abstinent cocaine users. [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00606801 on ClinicalTrials.gov Archive Site
Galantamine also directly potentiates nicotine receptors which may result in improved cognitive performance [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Galantamine Effects on Cognitive Function in Abstinent Cocaine Users
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.

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Abstinent Cocaine Users
  • Drug: Galantamine
    Galantamine 8 mg/day
  • Drug: placebo
    sugar pill
  • Active Comparator: 1
    Galantamine 8 mg/day
    Intervention: Drug: Galantamine
  • Placebo Comparator: 2
    placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
February 2009
February 2009   (final data collection date for primary outcome measure)

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
Both
21 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00606801
HIC # 0706002768, HSS Number 0026, P50DA009241, B Rounsaville
Yes
Mehmet Sofuoglu M.D., Ph.D., Yale University
Yale University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Mehmet Sofuoglu, M.D., Ph.D. Yale University Associate Professor
Yale University
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP