Trial · NCT00606801

Galantamine Effects on Cognitive Function in Abstinent Cocaine Users

NCT00606801, Not applicable, Completed, Yale University; results first posted 2013-07-31

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Galantamine Effects on Cognitive Function in Abstinent Cocaine Users. Trials, record NCT00606801. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00606801

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Galantamine Effects on Cognitive Function in Abstinent Cocaine Users
NCT number: NCT00606801
Status: Completed
Phases: Not applicable
Enrollment: 34 participants, actual
Lead sponsor: Yale University
Conditions: Cocaine Abuse
Interventions: Galantamine, placebo
First posted: 2008-02-05
Last updated: 2021-03-15
Results first posted: 2013-07-31
Limitations and caveats: Relatively low medication dose and short duration of treatment. Multiple cognitive tests and outcome measures increase probability of Type 1 errors. Absence of non-addicted controls limits determination of a unique effect in abstinent users.

Source ClinicalTrials.gov

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Reaction Time	Baseline, Day 5 and Day 10	Rapid Visual Processing test (RVIP) is a measure of sustained attention with a small working memory component that is sensitive to cholinergic enhancers. In the RVIP, subjects must detect either odd or even 3 digit sequences appearing in a box in a pseudo-random order at 100 digits per minute. Reaction time (RT) to correct answers was measured.
Primary	Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Total Hits	Baseline, Day 5 and Day 10	Rapid Visual Processing test (RVIP) is a measure of sustained attention with a small working memory component that is sensitive to cholinergic enhancers. In the RVIP, subjects must detect either odd or even 3 digit sequences appearing in a box in a pseudo-random order at 100 digits per minute. The total hits were measured
Primary	Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Total Correct Rejections	Baseline, Day 5 and Day 10	Rapid Visual Processing test (RVIP) is a measure of sustained attention with a small working memory component that is sensitive to cholinergic enhancers. In the RVIP, subjects must detect either odd or even 3 digit sequences appearing in a box in a pseudo-random order at 100 digits per minute. The number of correct rejections was measured.
Primary	Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP A' (Sensitivity to Target Sequences)	Baseline, Day 5 and Day 10	Rapid Visual Processing test (RVIP) is a measure of sustained attention with a small working memory component that is sensitive to cholinergic enhancers. In the RVIP, subjects must detect either odd or even 3 digit sequences appearing in a box in a pseudo-random order at 100 digits per minute. A' is a measure of sensitivity to target sequences and it reflects probabilities of hits and false alarms to provide a score of sensitivity to the target regardless of response tendency. The scores range from 0 (bad) to 1 (good).
Primary	Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP B' (Strength to Detect to Target Sequences)	Baseline, Day 5 and Day 10	Rapid Visual Processing test (RVIP) is a measure of sustained attention with a small working memory component that is sensitive to cholinergic enhancers. In the RVIP, subjects must detect either odd or even 3 digit sequences appearing in a box in a pseudo-random order at 100 digits per minute. B reflects the probability of hits and false alarms to provide a measure of the participants tendency to respond regardless of whether the target sequence is presented. The scores range from -1 to +1 with scores near +1 indicative of a subject that gave few false alarms.
Primary	Paired Associate Learning (PAL) - Stages Complete	Baseline, Day 5 and Day 10	Rapid Visual Processing test (RVIP) is a measure of sustained attention with a small working memory component that is sensitive to cholinergic enhancers. In the Paired Associate Learning (PAL) task, boxes are displayed on the screen and are opened in a random order. One or more of the boxes will contain a pattern. After the subjects have seen the patterns behind each box, the patterns are then displayed in the middle of the screen, one at a time, and the subject must touch the box where the pattern was originally located. An error will cause the test to open the boxes again to remind the subject of their locations. The number of boxes with patterns increases throughout the test. The stages completed and number of errors are measures of interest.
Primary	Paired Associate Learning (PAL) - Mean Errors	Baseline, Day 5 and Day 10	Rapid Visual Processing test (RVIP) is a measure of sustained attention with a small working memory component that is sensitive to cholinergic enhancers. In the Paired Associate Learning (PAL) task, boxes are displayed on the screen and are opened in a random order. One or more of the boxes will contain a pattern. After the subjects have seen the patterns behind each box, the patterns are then displayed in the middle of the screen, one at a time, and the subject must touch the box where the pattern was originally located. An error will cause the test to open the boxes again to remind the subject of their locations. The number of boxes with patterns increases throughout the test. The stages completed and number of errors are measures of interest.
Primary	Pattern Recognition Memory (PRM) - Response Time for Correct Answers	Baseline, Day 5 and Day 10	In the PRM, the subject is presented with a series of 12 visual patterns, one at a time, in the center of the screen. These patterns are designed so that they cannot easily be given verbal labels. In the recognition phase, the subject is required to choose between a pattern they have already seen and a novel pattern. The time to correct answer was measured.
Primary	Pattern Recognition Memory (PRM) - Number Correct Answers	Baseline, Day 5 and Day 10	Pattern Recognition Memory (PRM) tests visual pattern recognition memory in a two choice forced discrimination paradigm. 12 visual patterns are presented, then the subject must choose between each of these patterns and a novel pattern. The number of correct responses are measured.
Secondary	Performance on the Sustained Attention to Response Task (SART) - Number of Errors on NoGo Trials	Baseline, Day 5 and Day 10	The SART is a Go / NoGo task measuring the ability to activate or inhibit responses. In this 4.5 minute task, 225 single digits (25 × 9 digits) were presented on a computer monitor. Each digit was presented for 250 ms, and was immediately followed by a mask for 900 ms. The mask consists of a ring with a diagonal cross in the center. Subjects were instructed to press a spacebar to every digit except the 3, and to give equal importance to speed and accuracy. Responses were allowed during the presentation of both the digit and mask. The digits were presented in a different random order for each subject. There were 18 practice trials, containing 2 no-response targets (3s). For the Go/NoGo task, response inhibition was measured as the number of errors on the no- Go trials, with low errors indicating better response inhibition. Complete data for 3 subjects in the Placebo group, and for 1 subject in the galantamine group were not capture do to experimenter and computer errors.

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Reaction Time	Baseline, Day 5 and Day 10	There were a total of 28 completers, 14 for each treatment group. However, CANTAB data was not stored on the hard drive for one subject in the Galantamine group.	milliseconds	MEAN
PRIMARY	Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Total Hits	Baseline, Day 5 and Day 10	There were a total of 28 completers, 14 for each treatment group. However, CANTAB data was not stored on the hard drive for one subject in the Galantamine group.	hits	MEAN
PRIMARY	Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Total Correct Rejections	Baseline, Day 5 and Day 10	There were a total of 28 completers, 14 for each treatment group. However, CANTAB data was not stored on the hard drive for one subject in the Galantamine group.	correct rejections	MEAN
PRIMARY	Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP A' (Sensitivity to Target Sequences)	Baseline, Day 5 and Day 10	There were a total of 28 completers, 14 for each treatment group. However, CANTAB data was not stored on the hard drive for one subject in the Galantamine group.	sensitivity index	MEAN
PRIMARY	Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP B' (Strength to Detect to Target Sequences)	Baseline, Day 5 and Day 10	There were a total of 28 completers, 14 for each treatment group. However, CANTAB data was not stored on the hard drive for one subject in the Galantamine group.	specificity index	MEAN
PRIMARY	Paired Associate Learning (PAL) - Stages Complete	Baseline, Day 5 and Day 10	There were a total of 28 completers, 14 for each treatment group. However, CANTAB data was not stored on the hard drive for one subject in the Galantamine group.	completed stages	MEAN
PRIMARY	Paired Associate Learning (PAL) - Mean Errors	Baseline, Day 5 and Day 10	There were a total of 28 completers, 14 for each treatment group. However, CANTAB data was not stored on the hard drive for one subject in the Galantamine group.	errors	MEAN
PRIMARY	Pattern Recognition Memory (PRM) - Response Time for Correct Answers	Baseline, Day 5 and Day 10	There were a total of 28 completers, 14 for each treatment group. However, CANTAB data was not stored on the hard drive for one subject in the Galantamine group.	milliseconds	MEAN
PRIMARY	Pattern Recognition Memory (PRM) - Number Correct Answers	Baseline, Day 5 and Day 10	There were a total of 28 completers, 14 for each treatment group. However, CANTAB data was not stored on the hard drive for one subject in the Galantamine group.	number correct answers	MEAN
SECONDARY	Performance on the Sustained Attention to Response Task (SART) - Number of Errors on NoGo Trials	Baseline, Day 5 and Day 10	Participants analyzed are those that completed the treatment phase.	number of errors	MEAN

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group90

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Reaction Time	Placebo	Baseline	407.7	Standard Deviation 92.3	milliseconds
Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Reaction Time	Galantamine	Baseline	476.8	Standard Deviation 119.3	milliseconds
Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Reaction Time	Placebo	Day 5	427.4	Standard Deviation 35.3	milliseconds
Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Reaction Time	Galantamine	Day 5	379.2	Standard Deviation 71.7	milliseconds
Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Reaction Time	Placebo	Day 10	433.3	Standard Deviation 123.6	milliseconds
Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Reaction Time	Galantamine	Day 10	386.9	Standard Deviation 82.9	milliseconds
Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Total Hits	Placebo	Baseline	16.7	Standard Deviation 3.6	hits
Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Total Hits	Galantamine	Baseline	14.8	Standard Deviation 4.7	hits
Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Total Hits	Placebo	Day 5	18.0	Standard Deviation 5.0	hits
Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Total Hits	Galantamine	Day 5	16.9	Standard Deviation 5.4	hits

1 to 10 of 90Source ClinicalTrials.gov

See all 90 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Adaptation	STARTED	Placebo	17
Adaptation	STARTED	Galantamine 8 mg/Day	17
Adaptation	COMPLETED	Placebo	17
Adaptation	COMPLETED	Galantamine 8 mg/Day	17
Adaptation	NOT COMPLETED	Placebo	0
Adaptation	NOT COMPLETED	Galantamine 8 mg/Day	0
Intervention	STARTED	Placebo	17
Intervention	STARTED	Galantamine 8 mg/Day	17
Intervention	COMPLETED	Placebo	14
Intervention	COMPLETED	Galantamine 8 mg/Day	14

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Galantamine 8 mg/Day
Total, all-cause mortality	Placebo
Total, other adverse events	Galantamine 8 mg/Day	0	17
Total, other adverse events	Placebo	0	17
Total, serious adverse events	Galantamine 8 mg/Day	0	17
Total, serious adverse events	Placebo	0	17

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P50DA009241	Psychotherapy Development Research Center	CARROLL, KATHLEEN M.	YALE UNIVERSITY	NATIONAL INSTITUTE ON DRUG ABUSE	1994 to 2018

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Galantamine 8 mg/Day vs Placebo: serious adverse events

Source Trial comparisons

Tests5

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Paired Associate Learning	Primary outcome	ConductCognition
Pattern Recognition Memory	Primary outcome	ConductCognition
Go/No-Go Task	Secondary outcome	ConductCognition
Stroop Color-Word Test	Secondary outcome	ConductCognition
Sustained Attention to Response	Secondary outcome	ConductCognition

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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