Trial Outcomes & Findings for Cognitive Enhancement as a Target for Cocaine Pharmacotherapy (NCT NCT01531153)
NCT ID: NCT01531153
Last Updated: 2018-10-26
Results Overview
Presented are the average number of urine samples positive for cocaine over 12 weeks. This outcome was corrected from the protocol registration when the study data were entered.
COMPLETED
NA
93 participants
12 weeks
2018-10-26
Participant Flow
Participant milestones
| Measure |
Placebo
Sugar Pill will be compared with the active medication Galantamine
Placebo: Placebo dose.
|
Galantamine 8mg
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 8mg
|
Galantamine 16mg
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 16mg
|
|---|---|---|---|
|
Overall Study
STARTED
|
32
|
31
|
30
|
|
Overall Study
COMPLETED
|
22
|
22
|
15
|
|
Overall Study
NOT COMPLETED
|
10
|
9
|
15
|
Reasons for withdrawal
| Measure |
Placebo
Sugar Pill will be compared with the active medication Galantamine
Placebo: Placebo dose.
|
Galantamine 8mg
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 8mg
|
Galantamine 16mg
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 16mg
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
10
|
9
|
15
|
Baseline Characteristics
Cognitive Enhancement as a Target for Cocaine Pharmacotherapy
Baseline characteristics by cohort
| Measure |
Placebo
n=32 Participants
Sugar Pill will be compared with the active medication Galantamine
Placebo: Placebo dose.
|
Galantamine 8mg
n=31 Participants
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 8mg
|
Galantamine 16mg
n=30 Participants
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 16mg
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
48.1 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
47.4 years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
43.3 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
46.3 years
STANDARD_DEVIATION 7.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American
|
25 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
32 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
|
Marital Status
Married
|
29 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
|
Marital Status
Not Married
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Employment
Working
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Employment
Not Working
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
|
Education
Some College or More
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Education
High School
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Education
Less than High School
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Baseline Urine Positive
Cocaine
|
29 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
|
Baseline Urine Positive
Benzodiazepines
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Baseline Urine Positive
Marijuana
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPresented are the average number of urine samples positive for cocaine over 12 weeks. This outcome was corrected from the protocol registration when the study data were entered.
Outcome measures
| Measure |
Placebo
n=26 Participants
Sugar Pill will be compared with the active medication Galantamine
Placebo: Placebo dose.
|
Galantamine 8mg
n=24 Participants
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 8mg
|
Galantamine 16mg
n=22 Participants
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 16mg
|
|---|---|---|---|
|
Urine Toxicology
|
16.1 average cocaine positive urine samples
Standard Deviation 8.0
|
17 average cocaine positive urine samples
Standard Deviation 9.4
|
14.9 average cocaine positive urine samples
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: once a day for up to two days over 12 WeeksPopulation: Summary data for only those measured at each week are presented (per protocol).
Pulse
Outcome measures
| Measure |
Placebo
n=26 Participants
Sugar Pill will be compared with the active medication Galantamine
Placebo: Placebo dose.
|
Galantamine 8mg
n=24 Participants
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 8mg
|
Galantamine 16mg
n=26 Participants
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 16mg
|
|---|---|---|---|
|
Heart Rate
Week 1
|
78.85 beats per minute (bpm)
Standard Deviation 12.67
|
77.76 beats per minute (bpm)
Standard Deviation 9.24
|
75.01 beats per minute (bpm)
Standard Deviation 9.31
|
|
Heart Rate
Week 2
|
80.24 beats per minute (bpm)
Standard Deviation 13.61
|
79.74 beats per minute (bpm)
Standard Deviation 10.62
|
77.13 beats per minute (bpm)
Standard Deviation 10.62
|
|
Heart Rate
Week 3
|
78.68 beats per minute (bpm)
Standard Deviation 11.03
|
80.42 beats per minute (bpm)
Standard Deviation 8.15
|
74.98 beats per minute (bpm)
Standard Deviation 10.86
|
|
Heart Rate
Week 4
|
82.35 beats per minute (bpm)
Standard Deviation 11.18
|
77.83 beats per minute (bpm)
Standard Deviation 7.56
|
74.84 beats per minute (bpm)
Standard Deviation 8.52
|
|
Heart Rate
Week 5
|
80.91 beats per minute (bpm)
Standard Deviation 10.59
|
78.82 beats per minute (bpm)
Standard Deviation 9.25
|
76.72 beats per minute (bpm)
Standard Deviation 9.68
|
|
Heart Rate
Week 6
|
80.44 beats per minute (bpm)
Standard Deviation 11.17
|
75.55 beats per minute (bpm)
Standard Deviation 10.08
|
75.80 beats per minute (bpm)
Standard Deviation 10.08
|
|
Heart Rate
Week 7
|
78.65 beats per minute (bpm)
Standard Deviation 13.04
|
80.50 beats per minute (bpm)
Standard Deviation 9.03
|
76.48 beats per minute (bpm)
Standard Deviation 10.76
|
|
Heart Rate
Week 8
|
82.73 beats per minute (bpm)
Standard Deviation 12.34
|
77.46 beats per minute (bpm)
Standard Deviation 10.46
|
78.56 beats per minute (bpm)
Standard Deviation 10.02
|
|
Heart Rate
Week 9
|
80.59 beats per minute (bpm)
Standard Deviation 11.91
|
81.31 beats per minute (bpm)
Standard Deviation 9.81
|
78.09 beats per minute (bpm)
Standard Deviation 10.15
|
|
Heart Rate
Week 10
|
80.03 beats per minute (bpm)
Standard Deviation 13.02
|
81.28 beats per minute (bpm)
Standard Deviation 10.11
|
80.02 beats per minute (bpm)
Standard Deviation 12.00
|
|
Heart Rate
Week 11
|
82.90 beats per minute (bpm)
Standard Deviation 10.98
|
80.51 beats per minute (bpm)
Standard Deviation 11.16
|
80.02 beats per minute (bpm)
Standard Deviation 12.15
|
|
Heart Rate
Week 12
|
81.07 beats per minute (bpm)
Standard Deviation 10.49
|
76.33 beats per minute (bpm)
Standard Deviation 7.47
|
77.38 beats per minute (bpm)
Standard Deviation 12.60
|
SECONDARY outcome
Timeframe: 2 times a week for 12 weeksPopulation: Data are reported for those that were measured at each assessment.
Blood Pressure is taken for safety reasons
Outcome measures
| Measure |
Placebo
n=26 Participants
Sugar Pill will be compared with the active medication Galantamine
Placebo: Placebo dose.
|
Galantamine 8mg
n=24 Participants
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 8mg
|
Galantamine 16mg
n=26 Participants
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 16mg
|
|---|---|---|---|
|
Blood Pressure- Systolic
Week 1 Time 1
|
133.62 mmHg
Standard Deviation 14.01
|
127.75 mmHg
Standard Deviation 11.69
|
132.21 mmHg
Standard Deviation 13.68
|
|
Blood Pressure- Systolic
Week 1 Time 2
|
132.04 mmHg
Standard Deviation 14.27
|
125.70 mmHg
Standard Deviation 16.11
|
136.68 mmHg
Standard Deviation 16.46
|
|
Blood Pressure- Systolic
Week 2 Time 1
|
132.92 mmHg
Standard Deviation 14.89
|
125.62 mmHg
Standard Deviation 12.58
|
130.69 mmHg
Standard Deviation 13.56
|
|
Blood Pressure- Systolic
Week 2 Time 2
|
128.46 mmHg
Standard Deviation 12.46
|
129.65 mmHg
Standard Deviation 14.76
|
130.21 mmHg
Standard Deviation 16.53
|
|
Blood Pressure- Systolic
Week 3 Time 1
|
132.29 mmHg
Standard Deviation 13.81
|
123.05 mmHg
Standard Deviation 13.19
|
130.58 mmHg
Standard Deviation 17.35
|
|
Blood Pressure- Systolic
Week 3 Time 2
|
129.14 mmHg
Standard Deviation 16.10
|
131.50 mmHg
Standard Deviation 15.47
|
129.00 mmHg
Standard Deviation 28.65
|
|
Blood Pressure- Systolic
Week 4 Time 1
|
129.42 mmHg
Standard Deviation 15.34
|
131.47 mmHg
Standard Deviation 13.86
|
131.46 mmHg
Standard Deviation 12.55
|
|
Blood Pressure- Systolic
Week 4 Time 2
|
130.22 mmHg
Standard Deviation 15.13
|
130.40 mmHg
Standard Deviation 12.87
|
131.00 mmHg
Standard Deviation 13.16
|
|
Blood Pressure- Systolic
Week 5 Time 1
|
132.30 mmHg
Standard Deviation 17.50
|
133.12 mmHg
Standard Deviation 14.80
|
136.58 mmHg
Standard Deviation 14.83
|
|
Blood Pressure- Systolic
Week 5 Time 2
|
134.67 mmHg
Standard Deviation 16.21
|
128.47 mmHg
Standard Deviation 19.13
|
133.27 mmHg
Standard Deviation 15.71
|
|
Blood Pressure- Systolic
Week 6 Time 1
|
131.04 mmHg
Standard Deviation 17.66
|
125.94 mmHg
Standard Deviation 15.28
|
132.26 mmHg
Standard Deviation 17.56
|
|
Blood Pressure- Systolic
Week 6 Time 2
|
135.23 mmHg
Standard Deviation 16.01
|
124.21 mmHg
Standard Deviation 10.53
|
132.96 mmHg
Standard Deviation 10.45
|
|
Blood Pressure- Systolic
Week 7 Time 1
|
133.68 mmHg
Standard Deviation 12.44
|
121.50 mmHg
Standard Deviation 15.84
|
128.96 mmHg
Standard Deviation 15.62
|
|
Blood Pressure- Systolic
Week 7 Time 2
|
133.82 mmHg
Standard Deviation 14.32
|
125.27 mmHg
Standard Deviation 15.40
|
129.86 mmHg
Standard Deviation 12.87
|
|
Blood Pressure- Systolic
Week 8 Time 1
|
136.43 mmHg
Standard Deviation 19.92
|
129.56 mmHg
Standard Deviation 15.18
|
134.09 mmHg
Standard Deviation 17.12
|
|
Blood Pressure- Systolic
Week 8 Time 2
|
132.95 mmHg
Standard Deviation 17.00
|
133.00 mmHg
Standard Deviation 15.96
|
134.76 mmHg
Standard Deviation 14.74
|
|
Blood Pressure- Systolic
Week 9 Time 1
|
140.95 mmHg
Standard Deviation 43.91
|
121.93 mmHg
Standard Deviation 13.05
|
135.32 mmHg
Standard Deviation 14.36
|
|
Blood Pressure- Systolic
Week 9 Time 2
|
130.29 mmHg
Standard Deviation 19.31
|
130.43 mmHg
Standard Deviation 14.48
|
133.50 mmHg
Standard Deviation 17.32
|
|
Blood Pressure- Systolic
Week 10 Time 1
|
136.95 mmHg
Standard Deviation 16.85
|
127.00 mmHg
Standard Deviation 14.41
|
131.05 mmHg
Standard Deviation 15.08
|
|
Blood Pressure- Systolic
Week 10 Time 2
|
132.52 mmHg
Standard Deviation 13.13
|
121.07 mmHg
Standard Deviation 19.86
|
128.00 mmHg
Standard Deviation 15.70
|
|
Blood Pressure- Systolic
Week 11 Time 1
|
133.86 mmHg
Standard Deviation 14.23
|
125.79 mmHg
Standard Deviation 18.65
|
134.95 mmHg
Standard Deviation 23.90
|
|
Blood Pressure- Systolic
Week 11 Time 2
|
129.73 mmHg
Standard Deviation 16.59
|
125.71 mmHg
Standard Deviation 12.13
|
136.18 mmHg
Standard Deviation 16.28
|
|
Blood Pressure- Systolic
Week 12 Time 1
|
131.57 mmHg
Standard Deviation 15.10
|
125.54 mmHg
Standard Deviation 15.64
|
140.32 mmHg
Standard Deviation 18.56
|
|
Blood Pressure- Systolic
Week 12 Time 2
|
129.67 mmHg
Standard Deviation 18.11
|
131.85 mmHg
Standard Deviation 14.28
|
134.62 mmHg
Standard Deviation 11.38
|
SECONDARY outcome
Timeframe: 2 times a week for 12 weeksPopulation: Data are reported for those that were measured at each assessment.
Blood Pressure is taken for safety reasons
Outcome measures
| Measure |
Placebo
n=26 Participants
Sugar Pill will be compared with the active medication Galantamine
Placebo: Placebo dose.
|
Galantamine 8mg
n=24 Participants
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 8mg
|
Galantamine 16mg
n=26 Participants
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 16mg
|
|---|---|---|---|
|
Blood Pressure- Diastolic
Week 7 Time 1
|
79.05 mmHg
Standard Deviation 9.92
|
132.31 mmHg
Standard Deviation 200.73
|
79.83 mmHg
Standard Deviation 10.06
|
|
Blood Pressure- Diastolic
Week 1 Time 1
|
77.42 mmHg
Standard Deviation 11.61
|
78.75 mmHg
Standard Deviation 9.71
|
79.54 mmHg
Standard Deviation 7.55
|
|
Blood Pressure- Diastolic
Week 1 Time 2
|
79.13 mmHg
Standard Deviation 8.04
|
75.75 mmHg
Standard Deviation 11.80
|
80.88 mmHg
Standard Deviation 10.53
|
|
Blood Pressure- Diastolic
Week 2 Time 1
|
76.68 mmHg
Standard Deviation 10.48
|
76.48 mmHg
Standard Deviation 15.37
|
79.00 mmHg
Standard Deviation 10.99
|
|
Blood Pressure- Diastolic
Week 2 Time 2
|
77.46 mmHg
Standard Deviation 9.07
|
80.70 mmHg
Standard Deviation 11.85
|
79.42 mmHg
Standard Deviation 10.70
|
|
Blood Pressure- Diastolic
Week 3 Time 1
|
79.00 mmHg
Standard Deviation 9.04
|
78.79 mmHg
Standard Deviation 10.99
|
78.31 mmHg
Standard Deviation 10.39
|
|
Blood Pressure- Diastolic
Week 3 Time 2
|
74.59 mmHg
Standard Deviation 9.59
|
79.50 mmHg
Standard Deviation 11.15
|
78.35 mmHg
Standard Deviation 10.02
|
|
Blood Pressure- Diastolic
Week 4 Time 1
|
77.75 mmHg
Standard Deviation 10.61
|
81.88 mmHg
Standard Deviation 13.37
|
80.08 mmHg
Standard Deviation 8.67
|
|
Blood Pressure- Diastolic
Week 4 Time 2
|
76.09 mmHg
Standard Deviation 10.87
|
81.67 mmHg
Standard Deviation 12.12
|
80.13 mmHg
Standard Deviation 10.07
|
|
Blood Pressure- Diastolic
Week 5 Time 1
|
78.87 mmHg
Standard Deviation 11.29
|
81.41 mmHg
Standard Deviation 10.45
|
80.13 mmHg
Standard Deviation 8.27
|
|
Blood Pressure- Diastolic
Week 5 Time 2
|
76.48 mmHg
Standard Deviation 9.28
|
76.53 mmHg
Standard Deviation 12.17
|
80.36 mmHg
Standard Deviation 7.19
|
|
Blood Pressure- Diastolic
Week 6 Time 1
|
78.96 mmHg
Standard Deviation 9.15
|
80.63 mmHg
Standard Deviation 13.08
|
80.57 mmHg
Standard Deviation 10.12
|
|
Blood Pressure- Diastolic
Week 6 Time 2
|
77.77 mmHg
Standard Deviation 9.13
|
80.43 mmHg
Standard Deviation 10.45
|
83.22 mmHg
Standard Deviation 9.33
|
|
Blood Pressure- Diastolic
Week 7 Time 2
|
79.05 mmHg
Standard Deviation 10.82
|
80.00 mmHg
Standard Deviation 11.03
|
81.09 mmHg
Standard Deviation 10.92
|
|
Blood Pressure- Diastolic
Week 8 Time 1
|
80.43 mmHg
Standard Deviation 9.72
|
79.50 mmHg
Standard Deviation 8.63
|
81.82 mmHg
Standard Deviation 8.58
|
|
Blood Pressure- Diastolic
Week 8 Time 2
|
76.90 mmHg
Standard Deviation 10.23
|
82.71 mmHg
Standard Deviation 14.70
|
82.48 mmHg
Standard Deviation 8.61
|
|
Blood Pressure- Diastolic
Week 9 Time 1
|
102.64 mmHg
Standard Deviation 129.67
|
74.67 mmHg
Standard Deviation 12.82
|
81.27 mmHg
Standard Deviation 7.75
|
|
Blood Pressure- Diastolic
Week 9 Time 2
|
74.86 mmHg
Standard Deviation 9.24
|
83.50 mmHg
Standard Deviation 7.80
|
80.23 mmHg
Standard Deviation 9.89
|
|
Blood Pressure- Diastolic
Week 10 Time 1
|
78.32 mmHg
Standard Deviation 9.18
|
78.75 mmHg
Standard Deviation 12.87
|
81.71 mmHg
Standard Deviation 12.49
|
|
Blood Pressure- Diastolic
Week 10 Time 2
|
76.19 mmHg
Standard Deviation 7.49
|
77.57 mmHg
Standard Deviation 10.61
|
76.81 mmHg
Standard Deviation 8.02
|
|
Blood Pressure- Diastolic
Week 11 Time 1
|
80.95 mmHg
Standard Deviation 9.32
|
80.57 mmHg
Standard Deviation 12.18
|
85.05 mmHg
Standard Deviation 13.60
|
|
Blood Pressure- Diastolic
Week 11 Time 2
|
76.36 mmHg
Standard Deviation 13.17
|
75.36 mmHg
Standard Deviation 22.30
|
82.91 mmHg
Standard Deviation 12.50
|
|
Blood Pressure- Diastolic
Week 12 Time 1
|
79.76 mmHg
Standard Deviation 10.72
|
81.46 mmHg
Standard Deviation 8.92
|
84.00 mmHg
Standard Deviation 10.87
|
|
Blood Pressure- Diastolic
Week 12 Time 2
|
74.90 mmHg
Standard Deviation 12.48
|
80.15 mmHg
Standard Deviation 10.79
|
84.05 mmHg
Standard Deviation 9.60
|
SECONDARY outcome
Timeframe: Baseline and 12 WeeksPopulation: complete case analysis at 12 weeks
RVIP is a computerized measure of attention. This is given at baseline and every 4 weeks over the course of the 12-week study. RVP A' (aka RVIP A PRIME): is a signal detection measure of target sensitivity (i.e., successful response to targets and withholding of responses to non-targets). Range of 0 to 1. Higher scores are better.
Outcome measures
| Measure |
Placebo
n=17 Participants
Sugar Pill will be compared with the active medication Galantamine
Placebo: Placebo dose.
|
Galantamine 8mg
n=12 Participants
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 8mg
|
Galantamine 16mg
n=15 Participants
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 16mg
|
|---|---|---|---|
|
CANTAB RVIP Measure: RVP A
Baseline
|
.86 units on a scale
Standard Deviation .06
|
.86 units on a scale
Standard Deviation .05
|
.85 units on a scale
Standard Deviation .08
|
|
CANTAB RVIP Measure: RVP A
Week 12
|
.88 units on a scale
Standard Deviation .07
|
.84 units on a scale
Standard Deviation .12
|
.87 units on a scale
Standard Deviation .08
|
SECONDARY outcome
Timeframe: Baseline and 12 WeeksPopulation: complete case analysis at 12 weeks
RVIP is a computerized measure of attention. This is given at baseline and every 4 weeks over the course of the 12-week study. RVP B": A measure of response bias (i.e., bias towards under-responding (to targets) versus over-responding (i.e., to non-targets)) range from -1 to +1, respectively.
Outcome measures
| Measure |
Placebo
n=17 Participants
Sugar Pill will be compared with the active medication Galantamine
Placebo: Placebo dose.
|
Galantamine 8mg
n=12 Participants
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 8mg
|
Galantamine 16mg
n=15 Participants
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 16mg
|
|---|---|---|---|
|
CANTAB RVIP Measure: RVP B
Baseline
|
.77 units on a scale
Standard Deviation .42
|
.91 units on a scale
Standard Deviation .13
|
.77 units on a scale
Standard Deviation .22
|
|
CANTAB RVIP Measure: RVP B
Week 12
|
.77 units on a scale
Standard Deviation .42
|
.91 units on a scale
Standard Deviation .13
|
.77 units on a scale
Standard Deviation .22
|
SECONDARY outcome
Timeframe: Baseline and 12 WeeksPopulation: complete case analysis at 12 weeks
RVIP is a computerized measure of attention. This is given at baseline and every 4 weeks over the course of the 12-week study. RVP FALSE ALARM is probability of false alarm. False alarms are responses to non-targets. Higher numbers are worse (i.e., could be seen as a measure of poor response inhibition). Scores range from 0-1 where 1 is the least desirable probablity.
Outcome measures
| Measure |
Placebo
n=17 Participants
Sugar Pill will be compared with the active medication Galantamine
Placebo: Placebo dose.
|
Galantamine 8mg
n=12 Participants
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 8mg
|
Galantamine 16mg
n=15 Participants
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 16mg
|
|---|---|---|---|
|
CANTAB RVIP Measure: RVP FALSE ALARM
Baseline
|
.04 units on a scale
Standard Deviation .08
|
.01 units on a scale
Standard Deviation .02
|
.03 units on a scale
Standard Deviation .04
|
|
CANTAB RVIP Measure: RVP FALSE ALARM
Week 12
|
.03 units on a scale
Standard Deviation .03
|
.03 units on a scale
Standard Deviation .04
|
.02 units on a scale
Standard Deviation .02
|
SECONDARY outcome
Timeframe: Baseline and 12 WeeksPopulation: Complete cases analyzed at baseline and 12 weeks.
This is the CANTAB SST measure which evaluates response inhibition. Stop Signal Reaction Time (SSRT): The estimate of the length of time between the go stimulus and the stop stimulus at which the subject is able to successfully inhibit their response on 50% of the trials. Range of scores from 0 to 1500 (unit=milliseconds) and lower scores are 'better'.
Outcome measures
| Measure |
Placebo
n=17 Participants
Sugar Pill will be compared with the active medication Galantamine
Placebo: Placebo dose.
|
Galantamine 8mg
n=12 Participants
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 8mg
|
Galantamine 16mg
n=15 Participants
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 16mg
|
|---|---|---|---|
|
CANTAB SST- SSRT
Baseline
|
215.3 milliseconds
Standard Deviation 89.9
|
277.2 milliseconds
Standard Deviation 142.6
|
244.1 milliseconds
Standard Deviation 234.8
|
|
CANTAB SST- SSRT
12 Weeks
|
241.9 milliseconds
Standard Deviation 140.2
|
267.9 milliseconds
Standard Deviation 196.6
|
234.8 milliseconds
Standard Deviation 129.2
|
SECONDARY outcome
Timeframe: Baseline and 12 WeeksPopulation: Complete cases analyzed at baseline and 12 weeks.
This is the CANTAB SST measure which evaluates response inhibition. Stop Signal Reaction Time (SSRT): The estimate of the length of time between the go stimulus and the stop stimulus at which the subject is able to successfully inhibit their response on 50% of the trials. Range of scores from 0 to 1500 (unit=milliseconds) and lower scores are 'better'. Median correct is the median of response times across 'go' trials where the subject has responded on the correct button (right or left).
Outcome measures
| Measure |
Placebo
n=17 Participants
Sugar Pill will be compared with the active medication Galantamine
Placebo: Placebo dose.
|
Galantamine 8mg
n=12 Participants
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 8mg
|
Galantamine 16mg
n=15 Participants
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 16mg
|
|---|---|---|---|
|
CANTAB SST- Median Correct
Baseline
|
706.3 milliseconds
Standard Deviation 260.0
|
619.7 milliseconds
Standard Deviation 285.7
|
680.0 milliseconds
Standard Deviation 631.5
|
|
CANTAB SST- Median Correct
12 Weeks
|
608.6 milliseconds
Standard Deviation 201.6
|
669.7 milliseconds
Standard Deviation 323.5
|
631.5 milliseconds
Standard Deviation 150.6
|
SECONDARY outcome
Timeframe: Baseline and 12 WeeksPopulation: Complete cases analyzed at baseline and 12 weeks.
This is the CANTAB SST measure which evaluates response inhibition. Stop Signal Reaction Time (SSRT): The estimate of the length of time between the go stimulus and the stop stimulus at which the subject is able to successfully inhibit their response on 50% of the trials. Range of scores from 0 to 1500 (unit=milliseconds) and lower scores are 'better'. SD Correct is the standard deviation of response times across 'go' trials where the subject has responded on the correct button (right or left).
Outcome measures
| Measure |
Placebo
n=17 Participants
Sugar Pill will be compared with the active medication Galantamine
Placebo: Placebo dose.
|
Galantamine 8mg
n=12 Participants
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 8mg
|
Galantamine 16mg
n=15 Participants
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 16mg
|
|---|---|---|---|
|
CANTAB SST- SD Correct
Baseline
|
276.5 milliseconds
Standard Deviation 138.5
|
302.3 milliseconds
Standard Deviation 174.6
|
363.4 milliseconds
Standard Deviation 214.4
|
|
CANTAB SST- SD Correct
12 Weeks
|
337.8 milliseconds
Standard Deviation 262.9
|
410.6 milliseconds
Standard Deviation 276.1
|
492.6 milliseconds
Standard Deviation 530.5
|
SECONDARY outcome
Timeframe: weeks 0, 4, 8, 12, 16, 24, 36Population: Data are reported for those that were assessed at each visit.
Drug Stroop Task is a computerized task which presents words either cocaine-related ('drug') words or non-drug-related ('neutral') words written in colored font. The subject is asked to press a button to indicate the color of the font as quickly and accurately as possible. The task is thought to measure attentional bias to drug-related stimuli. RT Correct Neutral is the mean response time to neutral trials where the subject pressed the correct color response.
Outcome measures
| Measure |
Placebo
n=29 Participants
Sugar Pill will be compared with the active medication Galantamine
Placebo: Placebo dose.
|
Galantamine 8mg
n=28 Participants
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 8mg
|
Galantamine 16mg
n=28 Participants
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 16mg
|
|---|---|---|---|
|
Stroop- RT Correct Neutral
Baseline
|
785.18 milliseconds
Standard Deviation 183.55
|
805.24 milliseconds
Standard Deviation 158.88
|
871.07 milliseconds
Standard Deviation 191.15
|
|
Stroop- RT Correct Neutral
Week 4
|
821.37 milliseconds
Standard Deviation 202.21
|
813.66 milliseconds
Standard Deviation 182.02
|
845.66 milliseconds
Standard Deviation 164.98
|
|
Stroop- RT Correct Neutral
Week 8
|
817.69 milliseconds
Standard Deviation 220.50
|
741.33 milliseconds
Standard Deviation 169.06
|
830.22 milliseconds
Standard Deviation 175.45
|
|
Stroop- RT Correct Neutral
Week 12
|
764.53 milliseconds
Standard Deviation 182.65
|
756.00 milliseconds
Standard Deviation 134.75
|
816.47 milliseconds
Standard Deviation 180.70
|
|
Stroop- RT Correct Neutral
Week 16
|
849.17 milliseconds
Standard Deviation 274.21
|
802.90 milliseconds
Standard Deviation 219.22
|
895.03 milliseconds
Standard Deviation 136.86
|
|
Stroop- RT Correct Neutral
Week 24
|
814.09 milliseconds
Standard Deviation 255.82
|
769.47 milliseconds
Standard Deviation 191.59
|
876.61 milliseconds
Standard Deviation 230.52
|
|
Stroop- RT Correct Neutral
Week 36
|
824.54 milliseconds
Standard Deviation 274.04
|
747.65 milliseconds
Standard Deviation 99.74
|
989.42 milliseconds
Standard Deviation 156.74
|
SECONDARY outcome
Timeframe: weeks 0, 4, 8, 12, 16, 24, 36Population: Data are reported for those that were assessed at each visit.
Drug Stroop Task is a computerized task which presents words either cocaine-related ('drug') words or non-drug-related ('neutral') words written in colored font. The subject is asked to press a button to indicate the color of the font as quickly and accurately as possible. The task is thought to measure attentional bias to drug-related stimuli. RT Correct Drug is the mean response time to drug trials where the subject pressed the correct color response.
Outcome measures
| Measure |
Placebo
n=29 Participants
Sugar Pill will be compared with the active medication Galantamine
Placebo: Placebo dose.
|
Galantamine 8mg
n=28 Participants
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 8mg
|
Galantamine 16mg
n=28 Participants
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 16mg
|
|---|---|---|---|
|
Stroop- RT Correct Drug
Baseline
|
795.40 milliseconds
Standard Deviation 185.18
|
806.57 milliseconds
Standard Deviation 159.26
|
872.44 milliseconds
Standard Deviation 190.94
|
|
Stroop- RT Correct Drug
Week 4
|
825.09 milliseconds
Standard Deviation 203.50
|
815.97 milliseconds
Standard Deviation 182.08
|
846.59 milliseconds
Standard Deviation 165.73
|
|
Stroop- RT Correct Drug
Week 8
|
819.39 milliseconds
Standard Deviation 221.27
|
741.46 milliseconds
Standard Deviation 168.87
|
829.90 milliseconds
Standard Deviation 175.51
|
|
Stroop- RT Correct Drug
Week 12
|
766.90 milliseconds
Standard Deviation 181.53
|
755.87 milliseconds
Standard Deviation 135.32
|
817.91 milliseconds
Standard Deviation 180.55
|
|
Stroop- RT Correct Drug
Week 16
|
847.89 milliseconds
Standard Deviation 272.23
|
802.33 milliseconds
Standard Deviation 217.92
|
894.15 milliseconds
Standard Deviation 136.44
|
|
Stroop- RT Correct Drug
Week 24
|
812.65 milliseconds
Standard Deviation 254.72
|
768.93 milliseconds
Standard Deviation 189.97
|
874.56 milliseconds
Standard Deviation 229.66
|
|
Stroop- RT Correct Drug
Week 36
|
829.28 milliseconds
Standard Deviation 278.61
|
747.40 milliseconds
Standard Deviation 98.62
|
990.59 milliseconds
Standard Deviation 156.20
|
SECONDARY outcome
Timeframe: weeks 0, 4, 8, 12, 16, 24, 36Population: Data are reported for those that were assessed at each visit.
Drug Stroop Task is a computerized task which presents words either cocaine-related ('drug') words or non-drug-related ('neutral') words written in colored font. The subject is asked to press a button to indicate the color of the font as quickly and accurately as possible. The task is thought to measure attentional bias to drug-related stimuli. Stroop Effect is difference in response time to drug versus neutral trials (i.e., RT Correct Drug - RT Correct Neutral). A larger stroop effect is 'worse' (thought to indicate more attentional bias to drug related stimuli).
Outcome measures
| Measure |
Placebo
n=29 Participants
Sugar Pill will be compared with the active medication Galantamine
Placebo: Placebo dose.
|
Galantamine 8mg
n=28 Participants
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 8mg
|
Galantamine 16mg
n=28 Participants
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 16mg
|
|---|---|---|---|
|
Stroop- Effect Drug Neutral Mean Correct
Baseline
|
.22 milliseconds
Standard Deviation 10.60
|
1.33 milliseconds
Standard Deviation 5.21
|
1.37 milliseconds
Standard Deviation 4.09
|
|
Stroop- Effect Drug Neutral Mean Correct
Week 4
|
3.71 milliseconds
Standard Deviation 8.26
|
2.31 milliseconds
Standard Deviation 5.83
|
0.92 milliseconds
Standard Deviation 3.08
|
|
Stroop- Effect Drug Neutral Mean Correct
Week 8
|
1.69 milliseconds
Standard Deviation 4.24
|
0.13 milliseconds
Standard Deviation 3.40
|
-0.12 milliseconds
Standard Deviation 3.05
|
|
Stroop- Effect Drug Neutral Mean Correct
Week 12
|
2.36 milliseconds
Standard Deviation 6.23
|
-0.12 milliseconds
Standard Deviation 3.05
|
1.43 milliseconds
Standard Deviation 3.81
|
|
Stroop- Effect Drug Neutral Mean Correct
Week 16
|
-1.27 milliseconds
Standard Deviation 4.02
|
-0.56 milliseconds
Standard Deviation 2.77
|
-0.87 milliseconds
Standard Deviation 4.50
|
|
Stroop- Effect Drug Neutral Mean Correct
Week 24
|
-1.44 milliseconds
Standard Deviation 3.31
|
-0.53 milliseconds
Standard Deviation 2.24
|
-2.05 milliseconds
Standard Deviation 3.04
|
|
Stroop- Effect Drug Neutral Mean Correct
Week 36
|
4.73 milliseconds
Standard Deviation 5.53
|
-0.25 milliseconds
Standard Deviation 1.56
|
1.17 milliseconds
Standard Deviation 4.11
|
SECONDARY outcome
Timeframe: Baseline and 12 WeeksPopulation: Complete cases at 12 weeks were analyzed.
Digit Span Task description: Orally administered (not computerized) task where subjects are read-aloud lists of digits and asked to repeat them in the same order they heard them (Forward condition). Subjects are given a pair of lists for each digit length - and given a point for each list they get entirely correct. If they get at least one out of the two correct for that length, then the researcher gives them another one of a longer length (one digit longer). If they get both wrong at a given length- that task is ended. The task is then repeated with different digit lists to recall, but they are asked to repeat them or in the reverse order that they heard them (Backward condition). Longest Digit Span Forward (LDSF) is the longest digit span a participant gets correct, in the forward condition. Higher scores are better (Scale of 0 to 9).
Outcome measures
| Measure |
Placebo
n=22 Participants
Sugar Pill will be compared with the active medication Galantamine
Placebo: Placebo dose.
|
Galantamine 8mg
n=13 Participants
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 8mg
|
Galantamine 16mg
n=17 Participants
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 16mg
|
|---|---|---|---|
|
Digit Span- LDSF
Baseline
|
5.9 units on a scale
Standard Deviation 1.7
|
5.7 units on a scale
Standard Deviation 1.3
|
6.4 units on a scale
Standard Deviation 2.3
|
|
Digit Span- LDSF
12 Weeks
|
6.5 units on a scale
Standard Deviation 1.4
|
6.8 units on a scale
Standard Deviation 1.0
|
7.4 units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Baseline and 12 WeeksPopulation: Complete cases at 12 weeks were analyzed.
Digit Span Task description: Orally administered (not computerized) task where subjects are read-aloud lists of digits and asked to repeat them in the same order they heard them (Forward condition). Subjects are given a pair of lists for each digit length - and given a point for each list they get entirely correct. If they get at least one out of the two correct for that length, then the researcher gives them another one of a longer length (one digit longer). If they get both wrong at a given length- that task is ended. The task is then repeated with different digit lists to recall, but they are asked to repeat them or in the reverse order that they heard them (Backward condition). Digit Span Forward (DSF) is the number of digit span trials participants got correct in the forward condition. Higher scores are better (Scale of 0 to 14).
Outcome measures
| Measure |
Placebo
n=22 Participants
Sugar Pill will be compared with the active medication Galantamine
Placebo: Placebo dose.
|
Galantamine 8mg
n=13 Participants
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 8mg
|
Galantamine 16mg
n=19 Participants
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 16mg
|
|---|---|---|---|
|
Digit Span- DSF
Baseline
|
9.3 units on a scale
Standard Deviation 3.0
|
9.9 units on a scale
Standard Deviation 2.3
|
10.7 units on a scale
Standard Deviation 2.1
|
|
Digit Span- DSF
12 Weeks
|
10.5 units on a scale
Standard Deviation 2.6
|
10.7 units on a scale
Standard Deviation 1.8
|
11.2 units on a scale
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Baseline and 12 WeeksPopulation: Complete cases at 12 weeks were analyzed.
Digit Span Task description: Orally administered (not computerized) task where subjects are read-aloud lists of digits and asked to repeat them in the same order they heard them (Forward condition). Subjects are given a pair of lists for each digit length - and given a point for each list they get entirely correct. If they get at least one out of the two correct for that length, then the researcher gives them another one of a longer length (one digit longer). If they get both wrong at a given length- that task is ended. The task is then repeated with different digit lists to recall, but they are asked to repeat them or in the reverse order that they heard them (Backward condition). Longest Digit Span Backward (LDSB) is the longest digit span participants got correct, in the backward condition. Higher scores are better (Scale of 0 to 8).
Outcome measures
| Measure |
Placebo
n=22 Participants
Sugar Pill will be compared with the active medication Galantamine
Placebo: Placebo dose.
|
Galantamine 8mg
n=13 Participants
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 8mg
|
Galantamine 16mg
n=17 Participants
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 16mg
|
|---|---|---|---|
|
Digit Span- LDSB
Baseline
|
4.2 units on a scale
Standard Deviation 1.7
|
3.2 units on a scale
Standard Deviation 0.9
|
4.0 units on a scale
Standard Deviation 1.7
|
|
Digit Span- LDSB
12 Weeks
|
4.2 units on a scale
Standard Deviation 1.2
|
4.3 units on a scale
Standard Deviation 1.4
|
3.9 units on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Baseline and 12 WeeksPopulation: Complete cases at 12 weeks were analyzed.
Digit Span Task description: Orally administered (not computerized) task where subjects are read-aloud lists of digits and asked to repeat them in the same order they heard them (Forward condition). Subjects are given a pair of lists for each digit length - and given a point for each list they get entirely correct. If they get at least one out of the two correct for that length, then the researcher gives them another one of a longer length (one digit longer). If they get both wrong at a given length- that task is ended. The task is then repeated with different digit lists to recall, but they are asked to repeat them or in the reverse order that they heard them (Backward condition). Digit Span Forward (DSB) is the number of digit span trials participants got correct in the backward condition. Higher scores are better (Scale of 0 to 14).
Outcome measures
| Measure |
Placebo
n=22 Participants
Sugar Pill will be compared with the active medication Galantamine
Placebo: Placebo dose.
|
Galantamine 8mg
n=13 Participants
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 8mg
|
Galantamine 16mg
n=19 Participants
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 16mg
|
|---|---|---|---|
|
Digit Span- DSB
Baseline
|
8.3 units on a scale
Standard Deviation 3.1
|
7.2 units on a scale
Standard Deviation 1.5
|
7.6 units on a scale
Standard Deviation 1.9
|
|
Digit Span- DSB
12 Weeks
|
8.3 units on a scale
Standard Deviation 2.1
|
8.5 units on a scale
Standard Deviation 2.7
|
7.3 units on a scale
Standard Deviation 2.7
|
Adverse Events
Placebo
Galantamine 8mg
Galantamine 16mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=32 participants at risk
Sugar Pill will be compared with the active medication Galantamine
Placebo: Placebo dose.
|
Galantamine 8mg
n=31 participants at risk
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 8mg
|
Galantamine 16mg
n=30 participants at risk
Comparing the active medication with the placebo medication to see if the self administration cocaine decreases.
Galantamine: 16mg
|
|---|---|---|---|
|
Psychiatric disorders
Confusion
|
3.1%
1/32
|
3.2%
1/31
|
6.7%
2/30
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/32
|
3.2%
1/31
|
3.3%
1/30
|
|
Psychiatric disorders
Delusions
|
0.00%
0/32
|
0.00%
0/31
|
6.7%
2/30
|
|
Psychiatric disorders
Agitation
|
15.6%
5/32
|
9.7%
3/31
|
13.3%
4/30
|
|
General disorders
Tiredness
|
21.9%
7/32
|
19.4%
6/31
|
26.7%
8/30
|
|
General disorders
Drowsiness
|
0.00%
0/32
|
3.2%
1/31
|
6.7%
2/30
|
|
General disorders
Insomnia
|
15.6%
5/32
|
3.2%
1/31
|
16.7%
5/30
|
|
General disorders
Nightmares
|
6.2%
2/32
|
0.00%
0/31
|
6.7%
2/30
|
|
Psychiatric disorders
Irresponsible Behavior
|
6.2%
2/32
|
0.00%
0/31
|
3.3%
1/30
|
|
Psychiatric disorders
Depression
|
0.00%
0/32
|
9.7%
3/31
|
10.0%
3/30
|
|
Psychiatric disorders
Anxiety
|
12.5%
4/32
|
9.7%
3/31
|
13.3%
4/30
|
|
Nervous system disorders
Tingling
|
3.1%
1/32
|
0.00%
0/31
|
0.00%
0/30
|
|
Gastrointestinal disorders
Cramps
|
6.2%
2/32
|
3.2%
1/31
|
0.00%
0/30
|
|
General disorders
Headache
|
21.9%
7/32
|
6.5%
2/31
|
6.7%
2/30
|
|
Eye disorders
Blurred Vision
|
3.1%
1/32
|
6.5%
2/31
|
10.0%
3/30
|
|
General disorders
Dry Mouth
|
6.2%
2/32
|
6.5%
2/31
|
6.7%
2/30
|
|
Skin and subcutaneous tissue disorders
Increased Perspiration
|
3.1%
1/32
|
3.2%
1/31
|
3.3%
1/30
|
|
Skin and subcutaneous tissue disorders
Flushing
|
0.00%
0/32
|
3.2%
1/31
|
0.00%
0/30
|
|
Gastrointestinal disorders
Constipation
|
6.2%
2/32
|
3.2%
1/31
|
3.3%
1/30
|
|
Gastrointestinal disorders
Diarrhea
|
3.1%
1/32
|
6.5%
2/31
|
16.7%
5/30
|
|
Renal and urinary disorders
Urinary Frequency
|
9.4%
3/32
|
16.1%
5/31
|
6.7%
2/30
|
|
General disorders
Dizziness
|
6.2%
2/32
|
3.2%
1/31
|
0.00%
0/30
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
6.2%
2/32
|
0.00%
0/31
|
6.7%
2/30
|
|
Metabolism and nutrition disorders
Increased Appetite
|
6.2%
2/32
|
3.2%
1/31
|
0.00%
0/30
|
|
Gastrointestinal disorders
Heartburn
|
12.5%
4/32
|
0.00%
0/31
|
3.3%
1/30
|
|
Gastrointestinal disorders
Abdominal Pain
|
9.4%
3/32
|
3.2%
1/31
|
0.00%
0/30
|
|
Psychiatric disorders
Euphoria
|
0.00%
0/32
|
0.00%
0/31
|
3.3%
1/30
|
|
General disorders
Poor Concentration
|
3.1%
1/32
|
0.00%
0/31
|
0.00%
0/30
|
|
Nervous system disorders
Chills
|
3.1%
1/32
|
3.2%
1/31
|
3.3%
1/30
|
|
Psychiatric disorders
Increased Libido
|
3.1%
1/32
|
0.00%
0/31
|
3.3%
1/30
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
3.1%
1/32
|
6.5%
2/31
|
3.3%
1/30
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
6.2%
2/32
|
0.00%
0/31
|
6.7%
2/30
|
|
General disorders
Disturbed Concetration
|
0.00%
0/32
|
9.7%
3/31
|
10.0%
3/30
|
|
Psychiatric disorders
Decreased Libido
|
0.00%
0/32
|
0.00%
0/31
|
3.3%
1/30
|
|
Nervous system disorders
Fainting
|
3.1%
1/32
|
0.00%
0/31
|
0.00%
0/30
|
Additional Information
Dr. Mehmet Sofuoglu, Professor of Psychiatry; Director of VA New England Mental Illness Research, Ed
Yale University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place