Trial Outcomes & Findings for Imaging the Neurobiology of Behavioral and Medication Treatment for Cocaine Dependence (NCT NCT01468012)
NCT ID: NCT01468012
Last Updated: 2018-05-22
Results Overview
Abstinence will be assessed by urine toxicology results collected 3x/week during the 24 week trial or for the length of participation
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
23 participants
Primary outcome timeframe
collected 3x/week for 24 weeks of trial or for the duration of the participants involvement in the study.
Results posted on
2018-05-22
Participant Flow
Participant milestones
| Measure |
Levodopa Carbidopa and Entacapone (LCE)
400mg/100mg/200mg, twice daily dosing of levodopa carbidopa and entacapone (LCE)
levodopa carbidopa and entacapone (LCE): 400mg/100mg/200mg, twice daily
|
Placebo
placebo
Placebo: matched placebo for LCE condition dosed twice daily
|
Non-randomized
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
4
|
|
Overall Study
COMPLETED
|
7
|
9
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Imaging the Neurobiology of Behavioral and Medication Treatment for Cocaine Dependence
Baseline characteristics by cohort
| Measure |
Levodopa Carbidopa and Entacapone (LCE)
n=9 Participants
400mg/100mg/200mg, twice daily dosing of levodopa carbidopa and entacapone (LCE)
levodopa carbidopa and entacapone (LCE): 400mg/100mg/200mg, twice daily
|
Placebo
n=10 Participants
placebo
Placebo: matched placebo for LCE condition dosed twice daily
|
Non-randomized
n=4 Participants
|
Total
n=23 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
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
23 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
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
21 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
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: collected 3x/week for 24 weeks of trial or for the duration of the participants involvement in the study.Population: Urine toxicology results were not collected
Abstinence will be assessed by urine toxicology results collected 3x/week during the 24 week trial or for the length of participation
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 12 weeksThe number of participants who completed the 12-week medication phase of the study.
Outcome measures
| Measure |
Levodopa Carbidopa and Entacapone (LCE)
n=9 Participants
400mg/100mg/200mg, twice daily dosing of levodopa carbidopa and entacapone (LCE)
levodopa carbidopa and entacapone (LCE): 400mg/100mg/200mg, twice daily
|
Placebo
n=10 Participants
placebo
Placebo: matched placebo for LCE condition dosed twice daily
|
Non-randomized
n=4 Participants
|
|---|---|---|---|
|
Retention in Treatment
|
7 participants
|
9 participants
|
0 participants
|
Adverse Events
Levodopa Carbidopa and Entacapone (LCE)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Non-randomized
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Levodopa Carbidopa and Entacapone (LCE)
n=9 participants at risk
400mg/100mg/200mg, twice daily dosing of levodopa carbidopa and entacapone (LCE)
levodopa carbidopa and entacapone (LCE): 400mg/100mg/200mg, twice daily
|
Placebo
n=10 participants at risk
placebo
Placebo: matched placebo for LCE condition dosed twice daily
|
Non-randomized
n=4 participants at risk
Participants who dropped from the study prior to randomization
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Hospitalization for leg numbness
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
0.00%
0/4
|
|
Cardiac disorders
Hospitalization for shortness of breath
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Hospitalization for Leg pain
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
0.00%
0/4
|
|
Cardiac disorders
Hospitalization for chest pain
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
0.00%
0/4
|
Other adverse events
| Measure |
Levodopa Carbidopa and Entacapone (LCE)
n=9 participants at risk
400mg/100mg/200mg, twice daily dosing of levodopa carbidopa and entacapone (LCE)
levodopa carbidopa and entacapone (LCE): 400mg/100mg/200mg, twice daily
|
Placebo
n=10 participants at risk
placebo
Placebo: matched placebo for LCE condition dosed twice daily
|
Non-randomized
n=4 participants at risk
Participants who dropped from the study prior to randomization
|
|---|---|---|---|
|
Psychiatric disorders
Insomnia
|
0.00%
0/9
|
20.0%
2/10 • Number of events 2
|
0.00%
0/4
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
0.00%
0/4
|
|
General disorders
Dry Mouth
|
11.1%
1/9 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/4
|
|
General disorders
Fatigue
|
0.00%
0/9
|
30.0%
3/10 • Number of events 3
|
0.00%
0/4
|
|
Vascular disorders
Orthostatis
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
0.00%
0/4
|
|
Reproductive system and breast disorders
increased libido
|
11.1%
1/9 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/4
|
|
General disorders
Increased appetite
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
0.00%
0/4
|
|
Gastrointestinal disorders
GI Upset
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
0.00%
0/4
|
|
General disorders
Urinary Retention
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
0.00%
0/4
|
|
Reproductive system and breast disorders
Prolonged Erection
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
0.00%
0/4
|
|
Cardiac disorders
Irregular Heart rate
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
0.00%
0/4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place