Trial Outcomes & Findings for Investigation of Mifepristone (RU486) on Stress Sensitivity and Relapse Prevention in Cocaine Dependent Patients (NCT NCT01134198)
NCT ID: NCT01134198
Last Updated: 2018-12-20
Results Overview
assessed percent of sample with documented cocaine use by days 10 and 28 based on self reported use and urine toxicology. Those with documented use were considered to have relapsed.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
58 participants
Primary outcome timeframe
assessed during 8 weeks of trial, but reported for days 10 and 28 of trial
Results posted on
2018-12-20
Participant Flow
58 participants signed consent and were enrolled into the trial. Only 32 entered the randomized phase of the study with only 29 being assigned to one of the treatment arms.
Participant milestones
| Measure |
Mifepristone
Mifepristone 600mg
Mifepristone: Mifepristone 600mg, 3x/wk for 4 weeks
|
Placebo
Placebo
placebo: placebo
|
|---|---|---|
|
Phase 1
STARTED
|
16
|
13
|
|
Phase 1
COMPLETED
|
9
|
11
|
|
Phase 1
NOT COMPLETED
|
7
|
2
|
|
Phase 2
STARTED
|
9
|
11
|
|
Phase 2
COMPLETED
|
9
|
7
|
|
Phase 2
NOT COMPLETED
|
0
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Investigation of Mifepristone (RU486) on Stress Sensitivity and Relapse Prevention in Cocaine Dependent Patients
Baseline characteristics by cohort
| Measure |
Mifepristone
n=16 Participants
demographics for 16 participants who were randomized and started Phase 1.
Mifepristone 600mg, 3x/wk for 4 weeks.
|
Placebo
n=13 Participants
demographics for 13 participants who were randomized and started Phase 1.
Placebo 600mg, 3x/week for 4 weeks
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 8.3 • n=99 Participants
|
46 years
STANDARD_DEVIATION 8.3 • n=107 Participants
|
46 years
STANDARD_DEVIATION 8.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 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
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: assessed during 8 weeks of trial, but reported for days 10 and 28 of trialPopulation: participants entering phase 2 of trial
assessed percent of sample with documented cocaine use by days 10 and 28 based on self reported use and urine toxicology. Those with documented use were considered to have relapsed.
Outcome measures
| Measure |
Mifepristone
n=9 Participants
Mifepristone 600mg
Mifepristone: Mifepristone 600mg, 3x/wk for 4 weeks
|
Placebo
n=11 Participants
Placebo
placebo: placebo
|
|---|---|---|
|
Number of Participants With Relapse by Days 10 and 28
Day 10 · relapsed
|
3 Participants
|
8 Participants
|
|
Number of Participants With Relapse by Days 10 and 28
Day 10 · abstinent
|
6 Participants
|
3 Participants
|
|
Number of Participants With Relapse by Days 10 and 28
Day 28 · relapsed
|
5 Participants
|
8 Participants
|
|
Number of Participants With Relapse by Days 10 and 28
Day 28 · abstinent
|
4 Participants
|
3 Participants
|
Adverse Events
Mifepristone
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mifepristone
n=16 participants at risk
Mifepristone 600mg
Mifepristone: Mifepristone 600mg, 3x/wk for 4 weeks
|
Placebo
n=13 participants at risk
Placebo
placebo: placebo
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
31.2%
5/16 • Number of events 5 • Over 9 weeks (1 week of inpatient in phase 1 and 8 weeks in outpatient phase 2)
|
23.1%
3/13 • Number of events 3 • Over 9 weeks (1 week of inpatient in phase 1 and 8 weeks in outpatient phase 2)
|
|
General disorders
fatigue
|
12.5%
2/16 • Number of events 2 • Over 9 weeks (1 week of inpatient in phase 1 and 8 weeks in outpatient phase 2)
|
7.7%
1/13 • Number of events 1 • Over 9 weeks (1 week of inpatient in phase 1 and 8 weeks in outpatient phase 2)
|
|
Gastrointestinal disorders
constipation
|
12.5%
2/16 • Number of events 2 • Over 9 weeks (1 week of inpatient in phase 1 and 8 weeks in outpatient phase 2)
|
7.7%
1/13 • Number of events 1 • Over 9 weeks (1 week of inpatient in phase 1 and 8 weeks in outpatient phase 2)
|
|
General disorders
weakness
|
12.5%
2/16 • Number of events 2 • Over 9 weeks (1 week of inpatient in phase 1 and 8 weeks in outpatient phase 2)
|
7.7%
1/13 • Number of events 1 • Over 9 weeks (1 week of inpatient in phase 1 and 8 weeks in outpatient phase 2)
|
|
General disorders
insomnia/hypersomnia
|
12.5%
2/16 • Number of events 2 • Over 9 weeks (1 week of inpatient in phase 1 and 8 weeks in outpatient phase 2)
|
7.7%
1/13 • Number of events 1 • Over 9 weeks (1 week of inpatient in phase 1 and 8 weeks in outpatient phase 2)
|
|
Blood and lymphatic system disorders
elevated eosinophils
|
6.2%
1/16 • Number of events 1 • Over 9 weeks (1 week of inpatient in phase 1 and 8 weeks in outpatient phase 2)
|
0.00%
0/13 • Over 9 weeks (1 week of inpatient in phase 1 and 8 weeks in outpatient phase 2)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place