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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
  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.


Condition Intervention
Abstinent Cocaine Users
 Drug: Galantamine
Drug: placebo

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Improvement in cognitive performances in abstinent cocaine users. [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Galantamine also directly potentiates nicotine receptors which may result in improved cognitive performance [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: June 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Galantamine 8 mg/day
 Drug: Galantamine
Galantamine 8 mg/day
Placebo Comparator: 2
placebo
 Drug: placebo
sugar pill

Detailed 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 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.

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00606801

Locations
United States, Connecticut
Veterans Affairs Hospital
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Mehmet Sofuoglu, M.D., Ph.D. Yale University Associate Professor
  More Information

No publications provided

Responsible Party: Mehmet Sofuoglu M.D., Ph.D., Yale University
ClinicalTrials.gov Identifier: NCT00606801     History of Changes
Other Study ID Numbers: HIC # 0706002768, HSS Number 0026, P50DA009241, B Rounsaville
Study First Received: January 23, 2008
Last Updated: April 5, 2011
Health Authority: United States: Federal Government

Keywords provided by Yale University:
cognitive function

Additional relevant MeSH terms:
Galantamine
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nootropic Agents
 Central Nervous System Agents
Therapeutic Uses
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on May 21, 2013