Official Title: “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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment

Study Primary Completion Date: June 2008

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 active and enrolling human subjects. Currently we have screened 28 subjects with 12 completers.

Intervention(s) in this Clinical Trial

• Drug: Galantamine
  • Galantamine 8 mg/day
• Drug: placebo
  • sugar pill

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Galantamine 8 mg/day
• Placebo Comparator: 2
  • placebo

Primary Measures

• Improvement in cognitive performances in abstinent cocaine users.
  • Time Frame: one year
    Safety Issue?: No

Secondary Measures

• Galantamine also directly potentiates nicotine receptors which may result in improved cognitive performance
  • Time Frame: one year
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Overall Clinical Trial Officials and Contacts

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

Overall Contact: Lance Barnes 203-937-4823 lance.barnes@yale.edu

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00606801

Study ID Number: HIC # 0706002768

ClinicalTrials.gov Identifier: NCT00606801

Health Authority: United States: Federal Government