N/A N=34 Randomized Double-blind Treatment

Galantamine Effects on Cognitive Function in Abstinent Cocaine Users

Cocaine Abuse

Bottom Line

View on ClinicalTrials.gov: NCT00606801 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2013

Primary outcome: Primary: Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Reaction Time — 407.7; 476.8; 427.4; 379.2 milliseconds — p=0.006

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Galantamine (Drug); placebo (Drug)
Age: Adult · 21+ yrs
Sex: All
Sponsor: Yale University
Primary completion: Feb 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Reaction Time	407.7; 476.8; 427.4; 379.2; 433.3; 386.9	0.006 sig
PRIMARY Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Total Hits	16.7; 14.8; 18.0; 16.9; 18.0; 19.7	0.04 sig
PRIMARY Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Total Correct Rejections	247.2; 242.4; 217.6; 247.9; 248.2; 253.9	0.02 sig
PRIMARY Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP A' (Sensitivity to Target Sequences)	0.89; 0.87; 0.90; 0.90; 0.90; 0.92	0.03 sig
PRIMARY Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP B' (Strength to Detect to Target Sequences)	.88; .88; .82; .91; .85; .88	0.5
PRIMARY Paired Associate Learning (PAL) - Stages Complete	4.8; 4.9; 4.9; 4.9; 4.9; 4.9	0.7
PRIMARY Paired Associate Learning (PAL) - Mean Errors	31.1; 25.6; 23.6; 18.1; 17.7; 16.8	0.3
PRIMARY Pattern Recognition Memory (PRM) - Response Time for Correct Answers	2357; 2439; 2092; 2092; 1995; 1889	0.3
PRIMARY Pattern Recognition Memory (PRM) - Number Correct Answers	20.8; 20.2; 14.9; 20.6; 21.0; 20.7	0.3
SECONDARY Performance on the Sustained Attention to Response Task (SART) - Number of Errors on NoGo Trials	12.8; 13.1; 10.7; 10.2; 11.8; 12.2	0.9
SECONDARY Performance on the Sustained Attention to Response Task (SART)- Number of Errors on Go Trials	14.6; 7.2; 12.0; 3.8; 10.6; 5.1	0.8
SECONDARY Performance on the Sustained Attention to Response Task (SART)- Mean Reaction Time for Correct Press on Go Trial	399.7; 375.3; 405.4; 382.6; 411.1; 357.8	0.5
SECONDARY Performance on the Modified Stroop Task (Cocaine-Stroop)- Reaction Time	722; 771; 734; 742; 748; 698	0.01 sig
SECONDARY Performance on the Modified Stroop Task (Cocaine-Stroop)- Stroop Effect	10.5; -13.1; -19.7; 19.6; -61.5; -33.7	0.60
SECONDARY Performance on the Modified Stroop Task (Cocaine-Stroop)- Carry-over Effect	32.4; 13.4; 43.5; 32.1; -29.8; 18.6	0.50

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00606801). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.