Clinical trial NCT00606801: Galantamine Effects on Cognitive Function in Abstinent Cocaine Users
Official title: Galantamine Effects on Cognitive Function in Abstinent Cocaine Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cocaine Abuse
Keywords: cognitive enhancers
Nootropic Agents
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-02-05
Enrollment: 34
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Reaction Time
timeFrame: Baseline, Day 5 and Day 10
measure: Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Total Hits
timeFrame: Baseline, Day 5 and Day 10
measure: Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Total Correct Rejections
timeFrame: Baseline, Day 5 and Day 10
measure: Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP A' (Sensitivity to Target Sequences)
timeFrame: Baseline, Day 5 and Day 10
measure: Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP B' (Strength to Detect to Target Sequences)
timeFrame: Baseline, Day 5 and Day 10
measure: Paired Associate Learning (PAL) - Stages Complete
timeFrame: Baseline, Day 5 and Day 10
measure: Paired Associate Learning (PAL) - Mean Errors
timeFrame: Baseline, Day 5 and Day 10
measure: Pattern Recognition Memory (PRM) - Response Time for Correct Answers
timeFrame: Baseline, Day 5 and Day 10
measure: Pattern Recognition Memory (PRM) - Number Correct Answers
timeFrame: Baseline, Day 5 and Day 10
Secondary outcomes:
measure: Performance on the Sustained Attention to Response Task (SART) - Number of Errors on NoGo Trials
timeFrame: Baseline, Day 5 and Day 10
measure: Performance on the Sustained Attention to Response Task (SART)- Number of Errors on Go Trials
timeFrame: Baseline, Day 5 and Day 10
measure: Performance on the Sustained Attention to Response Task (SART)- Mean Reaction Time for Correct Press on Go Trial
timeFrame: Baseline, Day 5 and Day 10
measure: Performance on the Modified Stroop Task (Cocaine-Stroop)- Reaction Time
timeFrame: Baseline, Day 5 and Day 10
measure: Performance on the Modified Stroop Task (Cocaine-Stroop)- Stroop Effect
timeFrame: Baseline, Day 5 and Day 10
measure: Performance on the Modified Stroop Task (Cocaine-Stroop)- Carry-over Effect
timeFrame: Baseline, Day 5 and Day 10
Other outcomes:
Locations:
city: West Haven
country: United States
facility: Veterans Affairs Hospital
state: Connecticut
Study officials:
affiliation: Yale University Associate Professor
name: Mehmet Sofuoglu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: