Galantamine Effects on Cognitive Function in Abstinent Cocaine Users

NCT ID: NCT00606801

Last Updated: 2021-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2009-02-28

Brief Summary

To evaluate galantamine's effects on cognitive performance in abstinent cocaine users. Galantamine, a medication approved for treatment of Alzheimer's disease, is an acetylcholine esterase inhibitor. Galantamine also directly potentiates nicotine receptors. Both of these effects may result in improved cognitive performance in a group of subjects known to have impaired performance in various cognitive tasks.

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 Information 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. There were 28 completers. This study has been published.

Conditions

Cocaine Abuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Galantamine 8 mg/day

Galantamine 8 mg/day

Group Type: ACTIVE_COMPARATOR

Galantamine

Intervention Type: DRUG

Galantamine 8 mg/day

Placebo

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

sugar pill

Interventions

Galantamine

Galantamine 8 mg/day

Intervention Type: DRUG

placebo

sugar pill

Intervention Type: DRUG

Other Intervention Names

Nivalin,; Razadyne,; Razadyne ER,; Reminyl,; Lycoremine; Sugar Pill

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mehmet Sofuoglu, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University Associate Professor

Locations

Veterans Affairs Hospital

West Haven, Connecticut, United States

Countries

United States

Other Identifiers

P50DA009241

Identifier Type: NIH

Identifier Source: secondary_id

View Link

B Rounsaville

Identifier Type: OTHER

Identifier Source: secondary_id

0706002768

Identifier Type: -

Identifier Source: org_study_id