Trial Outcomes & Findings for Galantamine Effects on Cognitive Function in Abstinent Cocaine Users (NCT NCT00606801)
NCT ID: NCT00606801
Last Updated: 2021-03-15
Results Overview
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.
COMPLETED
NA
34 participants
Baseline, Day 5 and Day 10
2021-03-15
Participant Flow
Abstinent cocaine users recruited from 2007 to 2009 using word of mouth, fliers, and newspaper advertisements. This was an outpatient study conducted in a Yale University \& Veteran Affairs substance abuse research clinic.
55 subjects were screened. 21 subjects were excluded. (Not meeting inclusion criteria n=19, declined to participate n=2). These 34 subjects were then assigned to treatment groups. Prior to the 1st day of intervention, subjects underwent an adaptation session where they were familiarized with study procedures, and baseline measures were obtained.
Participant milestones
| Measure |
Placebo
Placebo given for 10 days.
|
Galantamine 8 mg/Day
Galantamine 8 mg/day given for 10 days.
|
|---|---|---|
|
Adaptation
STARTED
|
17
|
17
|
|
Adaptation
COMPLETED
|
17
|
17
|
|
Adaptation
NOT COMPLETED
|
0
|
0
|
|
Intervention
STARTED
|
17
|
17
|
|
Intervention
COMPLETED
|
14
|
14
|
|
Intervention
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Placebo given for 10 days.
|
Galantamine 8 mg/Day
Galantamine 8 mg/day given for 10 days.
|
|---|---|---|
|
Intervention
Protocol Violation
|
3
|
3
|
Baseline Characteristics
Galantamine Effects on Cognitive Function in Abstinent Cocaine Users
Baseline characteristics by cohort
| Measure |
Galantamine 8 mg/Day
n=17 Participants
Galantamine 8 mg/day given for 10 days.
|
Placebo
n=17 Participants
Placebo given for 10 days.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.1 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
42.7 years
STANDARD_DEVIATION 6.3 • n=7 Participants
|
42.5 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
17 participants
n=7 Participants
|
34 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 5 and Day 10Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=14 Participants
Measures on placebo group.
|
Galantamine
n=13 Participants
Measures on Galantamine group.
|
|---|---|---|
|
Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Reaction Time
Baseline
|
407.7 milliseconds
Standard Deviation 92.3
|
476.8 milliseconds
Standard Deviation 119.3
|
|
Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Reaction Time
Day 5
|
427.4 milliseconds
Standard Deviation 35.3
|
379.2 milliseconds
Standard Deviation 71.7
|
|
Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Reaction Time
Day 10
|
433.3 milliseconds
Standard Deviation 123.6
|
386.9 milliseconds
Standard Deviation 82.9
|
PRIMARY outcome
Timeframe: Baseline, Day 5 and Day 10Population: 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.
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
Outcome measures
| Measure |
Placebo
n=14 Participants
Measures on placebo group.
|
Galantamine
n=13 Participants
Measures on Galantamine group.
|
|---|---|---|
|
Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Total Hits
Baseline
|
16.7 hits
Standard Deviation 3.6
|
14.8 hits
Standard Deviation 4.7
|
|
Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Total Hits
Day 5
|
18.0 hits
Standard Deviation 5.0
|
16.9 hits
Standard Deviation 5.4
|
|
Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Total Hits
Day 10
|
18.0 hits
Standard Deviation 6.8
|
19.7 hits
Standard Deviation 4.3
|
PRIMARY outcome
Timeframe: Baseline, Day 5 and Day 10Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=14 Participants
Measures on placebo group.
|
Galantamine
n=13 Participants
Measures on Galantamine group.
|
|---|---|---|
|
Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Total Correct Rejections
Baseline
|
247.2 correct rejections
Standard Deviation 13.7
|
242.4 correct rejections
Standard Deviation 15.5
|
|
Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Total Correct Rejections
Day 5
|
217.6 correct rejections
Standard Deviation 16.9
|
247.9 correct rejections
Standard Deviation 12.9
|
|
Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP Total Correct Rejections
Day 10
|
248.2 correct rejections
Standard Deviation 23.7
|
253.9 correct rejections
Standard Deviation 12.6
|
PRIMARY outcome
Timeframe: Baseline, Day 5 and Day 10Population: 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.
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).
Outcome measures
| Measure |
Placebo
n=14 Participants
Measures on placebo group.
|
Galantamine
n=13 Participants
Measures on Galantamine group.
|
|---|---|---|
|
Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP A' (Sensitivity to Target Sequences)
Baseline
|
0.89 sensitivity index
Standard Deviation 0.04
|
0.87 sensitivity index
Standard Deviation 0.07
|
|
Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP A' (Sensitivity to Target Sequences)
Day 5
|
0.90 sensitivity index
Standard Deviation 0.07
|
0.90 sensitivity index
Standard Deviation 0.07
|
|
Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP A' (Sensitivity to Target Sequences)
Day 10
|
0.90 sensitivity index
Standard Deviation 0.10
|
0.92 sensitivity index
Standard Deviation 0.04
|
PRIMARY outcome
Timeframe: Baseline, Day 5 and Day 10Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=14 Participants
Measures on placebo group.
|
Galantamine
n=13 Participants
Measures on Galantamine group.
|
|---|---|---|
|
Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP B' (Strength to Detect to Target Sequences)
Baseline
|
.88 specificity index
Standard Deviation .18
|
.88 specificity index
Standard Deviation .25
|
|
Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP B' (Strength to Detect to Target Sequences)
Day 5
|
.82 specificity index
Standard Deviation .22
|
.91 specificity index
Standard Deviation .11
|
|
Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP B' (Strength to Detect to Target Sequences)
Day 10
|
.85 specificity index
Standard Deviation .25
|
.88 specificity index
Standard Deviation .14
|
PRIMARY outcome
Timeframe: Baseline, Day 5 and Day 10Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=14 Participants
Measures on placebo group.
|
Galantamine
n=13 Participants
Measures on Galantamine group.
|
|---|---|---|
|
Paired Associate Learning (PAL) - Stages Complete
Baseline
|
4.8 completed stages
Standard Deviation .4
|
4.9 completed stages
Standard Deviation .4
|
|
Paired Associate Learning (PAL) - Stages Complete
Day 5
|
4.9 completed stages
Standard Deviation .4
|
4.9 completed stages
Standard Deviation .4
|
|
Paired Associate Learning (PAL) - Stages Complete
Day 10
|
4.9 completed stages
Standard Deviation .4
|
4.9 completed stages
Standard Deviation .4
|
PRIMARY outcome
Timeframe: Baseline, Day 5 and Day 10Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=14 Participants
Measures on placebo group.
|
Galantamine
n=13 Participants
Measures on Galantamine group.
|
|---|---|---|
|
Paired Associate Learning (PAL) - Mean Errors
Day 10
|
17.7 errors
Standard Deviation 16.6
|
16.8 errors
Standard Deviation 13.7
|
|
Paired Associate Learning (PAL) - Mean Errors
Baseline
|
31.1 errors
Standard Deviation 22.3
|
25.6 errors
Standard Deviation 16.5
|
|
Paired Associate Learning (PAL) - Mean Errors
Day 5
|
23.6 errors
Standard Deviation 17.7
|
18.1 errors
Standard Deviation 11.5
|
PRIMARY outcome
Timeframe: Baseline, Day 5 and Day 10Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=14 Participants
Measures on placebo group.
|
Galantamine
n=13 Participants
Measures on Galantamine group.
|
|---|---|---|
|
Pattern Recognition Memory (PRM) - Response Time for Correct Answers
Baseline
|
2357 milliseconds
Standard Deviation 526
|
2439 milliseconds
Standard Deviation 685
|
|
Pattern Recognition Memory (PRM) - Response Time for Correct Answers
Day 5
|
2092 milliseconds
Standard Deviation 573
|
2092 milliseconds
Standard Deviation 522
|
|
Pattern Recognition Memory (PRM) - Response Time for Correct Answers
Day 10
|
1995 milliseconds
Standard Deviation 479
|
1889 milliseconds
Standard Deviation 364
|
PRIMARY outcome
Timeframe: Baseline, Day 5 and Day 10Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=14 Participants
Measures on placebo group.
|
Galantamine
n=13 Participants
Measures on Galantamine group.
|
|---|---|---|
|
Pattern Recognition Memory (PRM) - Number Correct Answers
Day 10
|
21.0 number correct answers
Standard Deviation 2.9
|
20.7 number correct answers
Standard Deviation 2.2
|
|
Pattern Recognition Memory (PRM) - Number Correct Answers
Baseline
|
20.8 number correct answers
Standard Deviation 3.2
|
20.2 number correct answers
Standard Deviation 2.5
|
|
Pattern Recognition Memory (PRM) - Number Correct Answers
Day 5
|
14.9 number correct answers
Standard Deviation 2.9
|
20.6 number correct answers
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Baseline, Day 5 and Day 10Population: Participants analyzed are those that completed the treatment phase.
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.
Outcome measures
| Measure |
Placebo
n=11 Participants
Measures on placebo group.
|
Galantamine
n=13 Participants
Measures on Galantamine group.
|
|---|---|---|
|
Performance on the Sustained Attention to Response Task (SART) - Number of Errors on NoGo Trials
Baseline
|
12.8 number of errors
Standard Deviation 6.4
|
13.1 number of errors
Standard Deviation 5.8
|
|
Performance on the Sustained Attention to Response Task (SART) - Number of Errors on NoGo Trials
Day 5
|
10.7 number of errors
Standard Deviation 6.5
|
10.2 number of errors
Standard Deviation 7.9
|
|
Performance on the Sustained Attention to Response Task (SART) - Number of Errors on NoGo Trials
Day 10
|
11.8 number of errors
Standard Deviation 7.7
|
12.2 number of errors
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: Baseline, Day 5 and Day 10Population: Participants analyzed are those that completed the treatment phase.
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). The number of errors on Go trials reflected the response activation function, with fewer errors indicating greater response activation. 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.
Outcome measures
| Measure |
Placebo
n=11 Participants
Measures on placebo group.
|
Galantamine
n=13 Participants
Measures on Galantamine group.
|
|---|---|---|
|
Performance on the Sustained Attention to Response Task (SART)- Number of Errors on Go Trials
Baseline
|
14.6 the number of errors
Standard Deviation 16.8
|
7.2 the number of errors
Standard Deviation 7.4
|
|
Performance on the Sustained Attention to Response Task (SART)- Number of Errors on Go Trials
Day 5
|
12.0 the number of errors
Standard Deviation 19.1
|
3.8 the number of errors
Standard Deviation 4.1
|
|
Performance on the Sustained Attention to Response Task (SART)- Number of Errors on Go Trials
Day 10
|
10.6 the number of errors
Standard Deviation 10.6
|
5.1 the number of errors
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: Baseline, Day 5 and Day 10Population: Participants analyzed are those that completed the treatment phase.
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 trial, the reaction time reflected the response activation function, faster reaction time indicating greater response activation. 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.
Outcome measures
| Measure |
Placebo
n=11 Participants
Measures on placebo group.
|
Galantamine
n=13 Participants
Measures on Galantamine group.
|
|---|---|---|
|
Performance on the Sustained Attention to Response Task (SART)- Mean Reaction Time for Correct Press on Go Trial
Baseline
|
399.7 milliseconds
Standard Deviation 79.7
|
375.3 milliseconds
Standard Deviation 88.5
|
|
Performance on the Sustained Attention to Response Task (SART)- Mean Reaction Time for Correct Press on Go Trial
Day 5
|
405.4 milliseconds
Standard Deviation 81.7
|
382.6 milliseconds
Standard Deviation 79.9
|
|
Performance on the Sustained Attention to Response Task (SART)- Mean Reaction Time for Correct Press on Go Trial
Day 10
|
411.1 milliseconds
Standard Deviation 74.2
|
357.8 milliseconds
Standard Deviation 109.7
|
SECONDARY outcome
Timeframe: Baseline, Day 5 and Day 10The Cocaine-Stroop task measures attention capture (attentional bias) secondary to cocaine cues; (Stroop effect - calculated as the difference between mean RT on cocaine words and mean RT on control words). Subjects completed 2 counterbalanced blocks (150 trials per block). One block contained 15 cocaine words and neutral words in a mixed order. The other block contained 15 control words matched in length and frequency to cocaine words, and a different set of neutral words. Subjects were required to indicate the colors in which the words were written as quickly and accurately as possible. Reaction times for identification of word color was measured. In addition, the difference in RT to words following cocaine and control words were measured (carry-over effect). Complete data for 3 participants (2 placebo and 1 galantamine) were not capture due to experimenter and computer errors.
Outcome measures
| Measure |
Placebo
n=12 Participants
Measures on placebo group.
|
Galantamine
n=13 Participants
Measures on Galantamine group.
|
|---|---|---|
|
Performance on the Modified Stroop Task (Cocaine-Stroop)- Reaction Time
Baseline
|
722 milliseconds
Standard Deviation 117
|
771 milliseconds
Standard Deviation 136
|
|
Performance on the Modified Stroop Task (Cocaine-Stroop)- Reaction Time
Day 5
|
734 milliseconds
Standard Deviation 126
|
742 milliseconds
Standard Deviation 145
|
|
Performance on the Modified Stroop Task (Cocaine-Stroop)- Reaction Time
Day 10
|
748 milliseconds
Standard Deviation 159
|
698 milliseconds
Standard Deviation 106
|
SECONDARY outcome
Timeframe: Baseline, Day 5 and Day 10The Cocaine-Stroop task measures attention capture (attentional bias) secondary to cocaine cues; (Stroop effect - calculated as the difference between mean RT on cocaine words and mean RT on control words). Subjects completed 2 counterbalanced blocks (150 trials per block). One block contained 15 cocaine words and neutral words in a mixed order. The other block contained 15 control words matched in length and frequency to cocaine words, and a different set of neutral words. Subjects were required to indicate the colors in which the words were written as quickly and accurately as possible. Reaction times for identification of word color was measured. In addition, the difference in RT to words following cocaine and control words were measured (carry-over effect). Complete data for 3 participants (2 placebo and 1 galantamine) were not capture due to experimenter and computer errors.
Outcome measures
| Measure |
Placebo
n=12 Participants
Measures on placebo group.
|
Galantamine
n=13 Participants
Measures on Galantamine group.
|
|---|---|---|
|
Performance on the Modified Stroop Task (Cocaine-Stroop)- Stroop Effect
Baseline
|
10.5 milliseconds
Standard Deviation 66.2
|
-13.1 milliseconds
Standard Deviation 137.6
|
|
Performance on the Modified Stroop Task (Cocaine-Stroop)- Stroop Effect
Day 5
|
-19.7 milliseconds
Standard Deviation 87.6
|
19.6 milliseconds
Standard Deviation 149.3
|
|
Performance on the Modified Stroop Task (Cocaine-Stroop)- Stroop Effect
Day 10
|
-61.5 milliseconds
Standard Deviation 183.9
|
-33.7 milliseconds
Standard Deviation 133.2
|
SECONDARY outcome
Timeframe: Baseline, Day 5 and Day 10The Cocaine-Stroop task measures attention capture (attentional bias) secondary to cocaine cues; (Stroop effect - calculated as the difference between mean RT on cocaine words and mean RT on control words). Subjects completed 2 counterbalanced blocks (150 trials per block). One block contained 15 cocaine words and neutral words in a mixed order. The other block contained 15 control words matched in length and frequency to cocaine words, and a different set of neutral words. Subjects were required to indicate the colors in which the words were written as quickly and accurately as possible. Reaction times for identification of word color was measured. In addition, the difference in RT to words following cocaine and control words were measured (carry-over effect). Complete data for 3 participants (2 placebo and 1 galantamine) were not capture due to experimenter and computer errors.
Outcome measures
| Measure |
Placebo
n=12 Participants
Measures on placebo group.
|
Galantamine
n=13 Participants
Measures on Galantamine group.
|
|---|---|---|
|
Performance on the Modified Stroop Task (Cocaine-Stroop)- Carry-over Effect
Baseline
|
32.4 milliseconds
Standard Deviation 95.5
|
13.4 milliseconds
Standard Deviation 131.9
|
|
Performance on the Modified Stroop Task (Cocaine-Stroop)- Carry-over Effect
Day 5
|
43.5 milliseconds
Standard Deviation 131.2
|
32.1 milliseconds
Standard Deviation 96.2
|
|
Performance on the Modified Stroop Task (Cocaine-Stroop)- Carry-over Effect
Day 10
|
-29.8 milliseconds
Standard Deviation 179.6
|
18.6 milliseconds
Standard Deviation 110.5
|
Adverse Events
Galantamine 8 mg/Day
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place