Trial Outcomes & Findings for Study of the Effects of Risperdal Consta on Brain Reward Circuitry Function, Craving and Cocaine Use in Active Cocaine Dependence (NCT NCT00385801)
NCT ID: NCT00385801
Last Updated: 2017-04-28
Results Overview
Measure of Dispersion/Precision not calculated, and raw data are no longer available
COMPLETED
PHASE2
31 participants
12 weeks
2017-04-28
Participant Flow
Participants were recruited from October 2005 to September 2006 via advertisement in local press
After baseline evaluation participants began treatment with oral risperidone, 1 mg per day the first week and 2 mg per day for the next 3 weeks. Electrocardiograms were repeated after 1 and 2 weeks of risperidone use. Participants with corrected QT interval (QTc) prolongation greater than 470 milliseconds at either of these occasions were excluded
Participant milestones
| Measure |
Placebo
Identical placebo tablets and injections
|
Risperidone Consta
Risperidone 1-2 mg tablets and Risperidone 25 mg injections
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
16
|
|
Overall Study
COMPLETED
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
9
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Effects of Risperdal Consta on Brain Reward Circuitry Function, Craving and Cocaine Use in Active Cocaine Dependence
Baseline characteristics by cohort
| Measure |
Placebo
n=15 Participants
Identical placebo tablets and injections
|
Risperidone Consta
n=16 Participants
Risperidone 1-2 mg tablets and Risperidone 25 mg injections
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.4 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
44.1 years
STANDARD_DEVIATION 5.9 • n=7 Participants
|
43 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Measure of Dispersion/Precision not calculated, and raw data are no longer available
Measure of Dispersion/Precision not calculated, and raw data are no longer available
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 12 weeksPopulation: Mean number of visits at which participants submitted urine samples with undetectable urine benzoylecgonine (UBE)
After randomization, participants provided urine samples every week for the first 3 weeks and then every 2 weeks for 8 weeks, up to 7 samples per participant. The average visits with cocaine negative urine samples per participant are reported below
Outcome measures
| Measure |
Placebo
n=15 Participants
Identical placebo tablets and injections
|
Risperidone Consta
n=16 Participants
Risperidone 1-2 mg tablets and Risperidone 25 mg injections
|
|---|---|---|
|
Cocaine Use by Quantitative Urine Samples
|
1.81 visit with negative UBE
Standard Deviation 2.29
|
0.87 visit with negative UBE
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Mixed model repeated measures analysis of variance was performed.
The University of Minnesota Cocaine Craving Scale was performed to assess cocaine craving. The scale contains 1 continuous scale for intensity and 2 categorical scales for frequency and duration of craving episodes. The continuous scale for craving intensity ranges from 0 (no craving at all in the past week) to 10 (a great deal of craving in the past week)
Outcome measures
| Measure |
Placebo
n=15 Participants
Identical placebo tablets and injections
|
Risperidone Consta
n=16 Participants
Risperidone 1-2 mg tablets and Risperidone 25 mg injections
|
|---|---|---|
|
Cocaine Craving
|
NA units on a scale
Standard Deviation NA
Raw data to calculate the mean values and measure of Dispersion/Precision are no longer available
|
NA units on a scale
Standard Deviation NA
Raw data to calculate the mean values and measure of Dispersion/Precision are no longer available
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Measure of Dispersion/Precision not calculated, and raw data are no longer available
Measure of Dispersion/Precision not calculated, and raw data are no longer available
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Risperidone Consta
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=15 participants at risk
Identical placebo tablets and injections
|
Risperidone Consta
n=16 participants at risk
Risperidone 1-2 mg tablets and Risperidone 25 mg injections
|
|---|---|---|
|
General disorders
Increased appetite
|
0.00%
0/15 • Adverse event data was collected at every visit
|
18.8%
3/16 • Adverse event data was collected at every visit
|
|
Respiratory, thoracic and mediastinal disorders
Common cold
|
0.00%
0/15 • Adverse event data was collected at every visit
|
25.0%
4/16 • Adverse event data was collected at every visit
|
|
Reproductive system and breast disorders
Sexual dysfunction
|
6.7%
1/15 • Adverse event data was collected at every visit
|
25.0%
4/16 • Adverse event data was collected at every visit
|
|
General disorders
Insomnia
|
0.00%
0/15 • Adverse event data was collected at every visit
|
12.5%
2/16 • Adverse event data was collected at every visit
|
|
General disorders
Dizziness
|
13.3%
2/15 • Adverse event data was collected at every visit
|
18.8%
3/16 • Adverse event data was collected at every visit
|
|
General disorders
Dry mouth
|
26.7%
4/15 • Adverse event data was collected at every visit
|
37.5%
6/16 • Adverse event data was collected at every visit
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
6.7%
1/15 • Adverse event data was collected at every visit
|
12.5%
2/16 • Adverse event data was collected at every visit
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
6.7%
1/15 • Adverse event data was collected at every visit
|
12.5%
2/16 • Adverse event data was collected at every visit
|
|
Gastrointestinal disorders
Dyspepsia
|
20.0%
3/15 • Adverse event data was collected at every visit
|
12.5%
2/16 • Adverse event data was collected at every visit
|
|
General disorders
Fatigue
|
20.0%
3/15 • Adverse event data was collected at every visit
|
56.2%
9/16 • Adverse event data was collected at every visit
|
|
General disorders
Somnolence
|
13.3%
2/15 • Adverse event data was collected at every visit
|
56.2%
9/16 • Adverse event data was collected at every visit
|
|
Psychiatric disorders
Depression
|
13.3%
2/15 • Adverse event data was collected at every visit
|
12.5%
2/16 • Adverse event data was collected at every visit
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.3%
2/15 • Adverse event data was collected at every visit
|
12.5%
2/16 • Adverse event data was collected at every visit
|
|
General disorders
Increased thirst
|
26.7%
4/15 • Adverse event data was collected at every visit
|
25.0%
4/16 • Adverse event data was collected at every visit
|
|
Nervous system disorders
Muscle rigidity, twitches
|
6.7%
1/15 • Adverse event data was collected at every visit
|
25.0%
4/16 • Adverse event data was collected at every visit
|
|
General disorders
Increased urination
|
0.00%
0/15 • Adverse event data was collected at every visit
|
12.5%
2/16 • Adverse event data was collected at every visit
|
|
General disorders
Fever
|
0.00%
0/15 • Adverse event data was collected at every visit
|
12.5%
2/16 • Adverse event data was collected at every visit
|
|
Nervous system disorders
Parasthesia, hypoesthesia
|
13.3%
2/15 • Adverse event data was collected at every visit
|
12.5%
2/16 • Adverse event data was collected at every visit
|
|
Nervous system disorders
Akathisia
|
0.00%
0/15 • Adverse event data was collected at every visit
|
12.5%
2/16 • Adverse event data was collected at every visit
|
|
Nervous system disorders
Tardive dyskinesia
|
0.00%
0/15 • Adverse event data was collected at every visit
|
6.2%
1/16 • Adverse event data was collected at every visit
|
|
General disorders
Other
|
20.0%
3/15 • Adverse event data was collected at every visit
|
43.8%
7/16 • Adverse event data was collected at every visit
|
Additional Information
A. Eden Evins, MD, MPH. Director of the MGH-Harvard Center for Addiction Medicine
Massachusetts General Hospital - Harvard Medical School
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place