Trial Outcomes & Findings for Contingency Management Treatment for Crack Addiction - Study With Brazilian Population (NCT NCT01815645)
NCT ID: NCT01815645
Last Updated: 2017-07-27
Results Overview
Number of Participants with 4, 8 and 12 Weeks Continued Abstinence
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
65 participants
Primary outcome timeframe
12 weeks of treatment
Results posted on
2017-07-27
Participant Flow
Participant milestones
| Measure |
Standard Treatment
standard treatment: 32 participants received 12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo)
|
Standard Treatment Plus Contingency Management
33 participants received Standard treatment plus Contingence Management: 12 weeks of the standard treatment offered by a open treatment service for drug addiction of the city of Sao Paulo (AME) plus Contingency Management
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
33
|
|
Overall Study
COMPLETED
|
32
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Contingency Management Treatment for Crack Addiction - Study With Brazilian Population
Baseline characteristics by cohort
| Measure |
Standard Treatment
n=32 Participants
standard treatment: 12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo)
|
Standard Treatment Plus Contingency Management
n=33 Participants
Standard treatment plus Contingence Management: 12 weeks of the standard treatment offered by a open treatment service for drug addiction of the city of Sao Paulo (AME) plus Contingency Management
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
65 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
35.4 years
STANDARD_DEVIATION 8.5 • n=93 Participants
|
35.3 years
STANDARD_DEVIATION 8.7 • n=4 Participants
|
35.3 years
STANDARD_DEVIATION 8.6 • n=27 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
56 Participants
n=27 Participants
|
|
Region of Enrollment
Brazil
|
32 participants
n=93 Participants
|
33 participants
n=4 Participants
|
65 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 weeks of treatmentPopulation: Longest duaration of abstinance was determined by the highest amount of consecutive negative crack/cocaine samples submitted.
Number of Participants with 4, 8 and 12 Weeks Continued Abstinence
Outcome measures
| Measure |
Standard Treatment
n=32 Participants
standard treatment: 12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo)
|
Standard Treatment Plus Contingency Management
n=33 Participants
Standard treatment plus Contingence Management: 12 weeks of the standard treatment offered by a open treatment service for drug addiction of the city of Sao Paulo (AME) plus Contingency Management
|
|---|---|---|
|
Longest Duaration of Achieved Abstinance
12 weeks of abstinance
|
0 number of participants
|
7 number of participants
|
|
Longest Duaration of Achieved Abstinance
8 weeks of abstinance
|
1 number of participants
|
8 number of participants
|
|
Longest Duaration of Achieved Abstinance
4 weeks of abstinance
|
1 number of participants
|
12 number of participants
|
PRIMARY outcome
Timeframe: 12 weeksProportion of samples testing negative for Crack Cocaine use
Outcome measures
| Measure |
Standard Treatment
n=113 urine samples
standard treatment: 12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo)
|
Standard Treatment Plus Contingency Management
n=628 urine samples
Standard treatment plus Contingence Management: 12 weeks of the standard treatment offered by a open treatment service for drug addiction of the city of Sao Paulo (AME) plus Contingency Management
|
|---|---|---|
|
Percentage Samples Submitted Negative for Crack Cocaine Use
|
8.3 percentage of submitted negative samples
|
46.5 percentage of submitted negative samples
|
PRIMARY outcome
Timeframe: Number of participant retained in treatment at weeks 4, 8 and 12.Retention in treatment was quantified as the period elapsed between treatment intake and dropout (last appearance at the treatment facility) or the end of treatment. We present data on the number of participants retained in treatment in weeks 4, 8 and 12.
Outcome measures
| Measure |
Standard Treatment
n=32 Participants
standard treatment: 12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo)
|
Standard Treatment Plus Contingency Management
n=33 Participants
Standard treatment plus Contingence Management: 12 weeks of the standard treatment offered by a open treatment service for drug addiction of the city of Sao Paulo (AME) plus Contingency Management
|
|---|---|---|
|
Number of Participants Completing 4, 8 and 12 Weeks of Treatment
Retained in week 12
|
0 number of participants
|
17 number of participants
|
|
Number of Participants Completing 4, 8 and 12 Weeks of Treatment
Retained in week 8
|
8 number of participants
|
21 number of participants
|
|
Number of Participants Completing 4, 8 and 12 Weeks of Treatment
Retained in week 4
|
11 number of participants
|
22 number of participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: we compared group means for the total number of attended sessions.
Treatment attendance was expressed as the total number of sessions attended during the 12 weeks of treatment.
Outcome measures
| Measure |
Standard Treatment
n=32 Participants
standard treatment: 12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo)
|
Standard Treatment Plus Contingency Management
n=33 Participants
Standard treatment plus Contingence Management: 12 weeks of the standard treatment offered by a open treatment service for drug addiction of the city of Sao Paulo (AME) plus Contingency Management
|
|---|---|---|
|
Treatment Attendance
|
3.7 attended treatment sessions
Standard Deviation 5.9
|
19.5 attended treatment sessions
Standard Deviation 14.9
|
SECONDARY outcome
Timeframe: 12 weeksProportion of samples testing negative for alcohol use
Outcome measures
| Measure |
Standard Treatment
n=32 Participants
standard treatment: 12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo)
|
Standard Treatment Plus Contingency Management
n=33 Participants
Standard treatment plus Contingence Management: 12 weeks of the standard treatment offered by a open treatment service for drug addiction of the city of Sao Paulo (AME) plus Contingency Management
|
|---|---|---|
|
Percentage Samples Submitted Negative for Alcohol Use
|
9.4 percent of sample
|
53.9 percent of sample
|
SECONDARY outcome
Timeframe: 12 weeksThe proportion of samples testing negative for marijuana was determined by dividing the number of negative samples by the total number of expected samples (36 samples)
Outcome measures
| Measure |
Standard Treatment
n=36 percent of sample
standard treatment: 12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo)
|
Standard Treatment Plus Contingency Management
n=36 percent of sample
Standard treatment plus Contingence Management: 12 weeks of the standard treatment offered by a open treatment service for drug addiction of the city of Sao Paulo (AME) plus Contingency Management
|
|---|---|---|
|
Percentage Samples Submitted Negative for Marihuana Use
|
9.8 percent of sample
|
50.3 percent of sample
|
Adverse Events
Standard Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Treatment Plus Contingency Management
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