Trial Outcomes & Findings for Cognitive Remediation for Cocaine Dependence (NCT NCT01393457)
NCT ID: NCT01393457
Last Updated: 2018-03-29
Results Overview
The mean of the predicted probabilities (derived from generalized linear mixed models) of negative drug screens over all 10 weeks is reported, as per the analysis proposed in the protocol.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
119 participants
Primary outcome timeframe
10 weeks
Results posted on
2018-03-29
Participant Flow
119 were enrolled (that is, signed the consent); however, only 110 were randomized. Of the 9 that were not enrolled but not randomized, 1 was no longer interested after signing the consent, and 8 were lost to follow up.
Participant milestones
| Measure |
Ldopa + Ropinirole Low Dose
levodopa/carbidopa: 800/200 mg/d
Ropinirole 2 mg/d: 2 mg/d
|
Ldopa + Ropinirole High Dose
levodopa/carbidopa: 800/200 mg/d
Ropinirole 4 mg/d: 4 mg/d
|
Ldopa
levodopa/carbidopa 800/200 mg/d
|
Placebo
Placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
31
|
27
|
|
Overall Study
COMPLETED
|
14
|
14
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
12
|
12
|
15
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cognitive Remediation for Cocaine Dependence
Baseline characteristics by cohort
| Measure |
Ldopa + Ropinirole Low Dose
n=26 Participants
levodopa/carbidopa: 800/200 mg/d
Ropinirole 2 mg/d: 2 mg/d
|
Ldopa + Ropinirole High Dose
n=26 Participants
levodopa/carbidopa: 800/200 mg/d
Ropinirole 4 mg/d: 4 mg/d
|
Ldopa
n=31 Participants
levodopa/carbidopa 800/200 mg/d
|
Placebo
n=27 Participants
Placebo
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
44.96 years
STANDARD_DEVIATION 6.50 • n=5 Participants
|
46.04 years
STANDARD_DEVIATION 8.70 • n=7 Participants
|
48 years
STANDARD_DEVIATION 7.87 • n=5 Participants
|
47.11 years
STANDARD_DEVIATION 8.56 • n=4 Participants
|
46.6 years
STANDARD_DEVIATION 7.93 • n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
85 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
84 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
110 Participants
n=21 Participants
|
|
Number of days of cocaine use over the last 30 days
|
16.12 days
STANDARD_DEVIATION 8.08 • n=5 Participants
|
16.31 days
STANDARD_DEVIATION 9.64 • n=7 Participants
|
17.19 days
STANDARD_DEVIATION 8.46 • n=5 Participants
|
14.74 days
STANDARD_DEVIATION 8.69 • n=4 Participants
|
16.13 days
STANDARD_DEVIATION 8.65 • n=21 Participants
|
PRIMARY outcome
Timeframe: 10 weeksPopulation: intention to treat
The mean of the predicted probabilities (derived from generalized linear mixed models) of negative drug screens over all 10 weeks is reported, as per the analysis proposed in the protocol.
Outcome measures
| Measure |
Ldopa + Ropinirole Low Dose
n=26 Participants
levodopa/carbidopa: 800/200 mg/d
Ropinirole 2 mg/d: 2 mg/d
|
Ldopa + Ropinirole High Dose
n=26 Participants
levodopa/carbidopa: 800/200 mg/d
Ropinirole 4 mg/d: 4 mg/d
|
Ldopa
n=31 Participants
levodopa/carbidopa 800/200 mg/d
|
Placebo
n=27 Participants
Placebo
|
|---|---|---|---|---|
|
Cocaine Use Based on Urine Drug Screening
|
20.36 number of negative drug screens
Standard Deviation 29.51
|
15.57 number of negative drug screens
Standard Deviation 21.96
|
22.3 number of negative drug screens
Standard Deviation 28
|
27.8 number of negative drug screens
Standard Deviation 30.35
|
SECONDARY outcome
Timeframe: 10 weeksOutcome measures
| Measure |
Ldopa + Ropinirole Low Dose
n=26 Participants
levodopa/carbidopa: 800/200 mg/d
Ropinirole 2 mg/d: 2 mg/d
|
Ldopa + Ropinirole High Dose
n=26 Participants
levodopa/carbidopa: 800/200 mg/d
Ropinirole 4 mg/d: 4 mg/d
|
Ldopa
n=31 Participants
levodopa/carbidopa 800/200 mg/d
|
Placebo
n=27 Participants
Placebo
|
|---|---|---|---|---|
|
Number of Participants Who Completed the 10 Week Trial
|
14 participants
|
14 participants
|
16 participants
|
15 participants
|
Adverse Events
Ldopa + Ropinirole Low Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ldopa + Ropinirole High Dose
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Ldopa
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ldopa + Ropinirole Low Dose
n=26 participants at risk
levodopa/carbidopa: 800/200 mg/d
Ropinirole 2 mg/d: 2 mg/d
|
Ldopa + Ropinirole High Dose
n=26 participants at risk
levodopa/carbidopa: 800/200 mg/d
Ropinirole 4 mg/d: 4 mg/d
|
Ldopa
n=31 participants at risk
levodopa/carbidopa 800/200 mg/d
|
Placebo
n=27 participants at risk
Placebo
|
|---|---|---|---|---|
|
Cardiac disorders
Chest pain
|
0.00%
0/26 • weekly for 10 weeks
Side effects were not considered to be adverse events.
|
0.00%
0/26 • weekly for 10 weeks
Side effects were not considered to be adverse events.
|
0.00%
0/31 • weekly for 10 weeks
Side effects were not considered to be adverse events.
|
3.7%
1/27 • Number of events 1 • weekly for 10 weeks
Side effects were not considered to be adverse events.
|
|
Metabolism and nutrition disorders
Weight gain
|
0.00%
0/26 • weekly for 10 weeks
Side effects were not considered to be adverse events.
|
0.00%
0/26 • weekly for 10 weeks
Side effects were not considered to be adverse events.
|
0.00%
0/31 • weekly for 10 weeks
Side effects were not considered to be adverse events.
|
3.7%
1/27 • Number of events 1 • weekly for 10 weeks
Side effects were not considered to be adverse events.
|
|
Immune system disorders
Gout flare up
|
0.00%
0/26 • weekly for 10 weeks
Side effects were not considered to be adverse events.
|
0.00%
0/26 • weekly for 10 weeks
Side effects were not considered to be adverse events.
|
0.00%
0/31 • weekly for 10 weeks
Side effects were not considered to be adverse events.
|
3.7%
1/27 • Number of events 1 • weekly for 10 weeks
Side effects were not considered to be adverse events.
|
|
Psychiatric disorders
Suicide ideation
|
0.00%
0/26 • weekly for 10 weeks
Side effects were not considered to be adverse events.
|
3.8%
1/26 • Number of events 1 • weekly for 10 weeks
Side effects were not considered to be adverse events.
|
0.00%
0/31 • weekly for 10 weeks
Side effects were not considered to be adverse events.
|
0.00%
0/27 • weekly for 10 weeks
Side effects were not considered to be adverse events.
|
Other adverse events
Adverse event data not reported
Additional Information
Charles Green, PhD
The University of Texas Health Science Center at Houston
Phone: 713-500-6402
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place