Expired Study
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West Haven, Connecticut 06516


Purpose:

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 summary:

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.


Criteria:

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


Study is Available At:


Original ID:

HIC # 0706002768


NCT ID:

NCT00606801


Secondary ID:

HSS Number 0026


Study Acronym:


Brief Title:

Galantamine Effects on Cognitive Function in Abstinent Cocaine Users


Official Title:

Galantamine Effects on Cognitive Function in Abstinent Cocaine Users


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

21 Years


Maximum Age:

50 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Yale University


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Cros


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

27


Enrollment Type:

Actual


Overall Contact Information

Official Name:Mehmet Sofuoglu, M.D., Ph.D.
Principal Investigator
Yale University Associate Professor

Study Dates

Start Date:June 2007
Completion Date:February 2009
Completion Type:Actual
Primary Completion Date:February 2009
Primary Completion Type:Actual
Verification Date:April 2011
Last Changed Date:April 5, 2011
First Received Date:January 23, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Galantamine also directly potentiates nicotine receptors which may result in improved cognitive performance
Time Frame:one year
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Improvement in cognitive performances in abstinent cocaine users.
Time Frame:one year
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Galantamine
Description:Galantamine 8 mg/day
Arm Name:1
Intervention Type:Drug
Name:placebo
Description:sugar pill
Arm Name:2

Study Arms

Study Arm Type:Active Comparator
Arm Name:1
Description:Galantamine 8 mg/day
Study Arm Type:Placebo Comparator
Arm Name:2
Description:placebo

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Yale University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute on Drug Abuse (NIDA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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