Trial Outcomes & Findings for Striatal Effective Connectivity to Predict Treatment Response in Cocaine Misuse (NCT NCT02080819)
NCT ID: NCT02080819
Last Updated: 2018-04-12
Results Overview
Treatment effectiveness score based on number of positive urine drug screens
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
131 participants
Primary outcome timeframe
Baseline to 12 weeks
Results posted on
2018-04-12
Participant Flow
Participant milestones
| Measure |
Healthy Control
Non drug using healthy controls
|
Placebo
Placebo BID for 7 weeks
levodopa/carbidopa 400/100 BID: Levodopa dose escalation (1 week): Days 1-2, one 50/12.5 mg tablet BID; Days 3-4, one 100/25 mg tablet BID; Days 5-6, one 200/50 mg tablet BID; Day 7, one 400/100 mg tablet BID.
Maintenance phase (7 weeks): One 400/100 mg Levodopa/Carbidopa tablet BID or placebo in conjunction with once weekly individual cognitive behavioral therapy plus contingency management for attendance.
|
Medication
Levodopa/carbidopa 400/100 BID for 7 weeks
levodopa/carbidopa 400/100 BID: Levodopa dose escalation (1 week): Days 1-2, one 50/12.5 mg tablet BID; Days 3-4, one 100/25 mg tablet BID; Days 5-6, one 200/50 mg tablet BID; Day 7, one 400/100 mg tablet BID.
Maintenance phase (7 weeks): One 400/100 mg Levodopa/Carbidopa tablet BID or placebo in conjunction with once weekly individual cognitive behavioral therapy plus contingency management for attendance.
|
|---|---|---|---|
|
Overall Study
STARTED
|
63
|
35
|
33
|
|
Overall Study
COMPLETED
|
38
|
9
|
11
|
|
Overall Study
NOT COMPLETED
|
25
|
26
|
22
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Striatal Effective Connectivity to Predict Treatment Response in Cocaine Misuse
Baseline characteristics by cohort
| Measure |
Healthy Control
n=38 Participants
Non drug using healthy controls
|
Placebo
n=9 Participants
Placebo BID for 7 weeks
levodopa/carbidopa 400/100 BID: Levodopa dose escalation (1 week): Days 1-2, one 50/12.5 mg tablet BID; Days 3-4, one 100/25 mg tablet BID; Days 5-6, one 200/50 mg tablet BID; Day 7, one 400/100 mg tablet BID.
Maintenance phase (7 weeks): One 400/100 mg Levodopa/Carbidopa tablet BID or placebo in conjunction with once weekly individual cognitive behavioral therapy plus contingency management for attendance.
|
Medication
n=11 Participants
Levodopa/carbidopa 400/100 BID for 7 weeks
levodopa/carbidopa 400/100 BID: Levodopa dose escalation (1 week): Days 1-2, one 50/12.5 mg tablet BID; Days 3-4, one 100/25 mg tablet BID; Days 5-6, one 200/50 mg tablet BID; Day 7, one 400/100 mg tablet BID.
Maintenance phase (7 weeks): One 400/100 mg Levodopa/Carbidopa tablet BID or placebo in conjunction with once weekly individual cognitive behavioral therapy plus contingency management for attendance.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
58 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
30 years
STANDARD_DEVIATION 12 • n=99 Participants
|
33 years
STANDARD_DEVIATION 7 • n=107 Participants
|
35 years
STANDARD_DEVIATION 8 • n=206 Participants
|
33 years
STANDARD_DEVIATION 12 • n=7 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
34 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
40 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=99 Participants
|
9 participants
n=107 Participants
|
11 participants
n=206 Participants
|
30 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 weeksTreatment effectiveness score based on number of positive urine drug screens
Outcome measures
| Measure |
Healthy Control
n=38 Participants
Non drug using healthy controls
|
Placebo
n=9 Participants
Placebo BID for 7 weeks
levodopa/carbidopa 400/100 BID: Levodopa dose escalation (1 week): Days 1-2, one 50/12.5 mg tablet BID; Days 3-4, one 100/25 mg tablet BID; Days 5-6, one 200/50 mg tablet BID; Day 7, one 400/100 mg tablet BID.
Maintenance phase (7 weeks): One 400/100 mg Levodopa/Carbidopa tablet BID or placebo in conjunction with once weekly individual cognitive behavioral therapy plus contingency management for attendance.
|
Medication
n=11 Participants
Levodopa/carbidopa 400/100 BID for 7 weeks
levodopa/carbidopa 400/100 BID: Levodopa dose escalation (1 week): Days 1-2, one 50/12.5 mg tablet BID; Days 3-4, one 100/25 mg tablet BID; Days 5-6, one 200/50 mg tablet BID; Day 7, one 400/100 mg tablet BID.
Maintenance phase (7 weeks): One 400/100 mg Levodopa/Carbidopa tablet BID or placebo in conjunction with once weekly individual cognitive behavioral therapy plus contingency management for attendance.
|
|---|---|---|---|
|
Cocaine Treatment Outcome
|
0 positive drug screens
Standard Deviation 0
|
14 positive drug screens
Standard Deviation 15
|
13 positive drug screens
Standard Deviation 9
|
Adverse Events
Healthy Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Medication
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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