Trial Outcomes & Findings for Dane County Drug Court Study for Addicted Offenders (NCT NCT01843751)
NCT ID: NCT01843751
Last Updated: 2023-06-07
Results Overview
The primary outcome will be measured via the publicly available Wisconsin Circuit Court Consolidated Court Automation Program (CCAP) database. The Wisconsin Circuit Court Access website provides access to certain public records of the circuit courts of Wisconsin. The information displayed on the website is an exact copy of the case information entered into CCAP case management system by court staff in the counties where the case files are located. The court record summaries viewed are all public records under Wisconsin open records law and freely accessible to the public. The CCAP database will searched periodically for all enrolled study participants until data analysis has been complete.
COMPLETED
PHASE3
24 participants
2 years
2023-06-07
Participant Flow
Initially 24 participants consented,but 3 did not receive intervention or provide data, so only 21 participants were analyzed out of 24 enrolled.
Participant milestones
| Measure |
Physician Office
Buprenorphine/naloxone via physician office (B-PO) x 10 months
buprenorphine/naloxone: Buprenorphine/naloxone (Suboxone) is considered a well-investigated, highly effective medication-assisted treatment for opiate dependence, but it may only be supervised through the few specialist treatment facilities in the state, or by physicians who have historically been less likely to offer this service. The effectiveness of community physician treatment supervision has not been tested for those in the criminal justice system.
|
Specialist Center
Buprenorphine/naloxone via specialist center (B-SC) x 3 months followed by B-PO x 7 months. The specialist center in this trial will be a methadone clinic.
buprenorphine/naloxone: Buprenorphine/naloxone (Suboxone) is considered a well-investigated, highly effective medication-assisted treatment for opiate dependence, but it may only be supervised through the few specialist treatment facilities in the state, or by physicians who have historically been less likely to offer this service. The effectiveness of community physician treatment supervision has not been tested for those in the criminal justice system.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
|
Overall Study
COMPLETED
|
0
|
3
|
|
Overall Study
NOT COMPLETED
|
11
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One participant in Specialist arm did not enter "Sex" information.
Baseline characteristics by cohort
| Measure |
Physician Office
n=11 Participants
Buprenorphine/naloxone via physician office (B-PO) x 10 months
buprenorphine/naloxone: Buprenorphine/naloxone (Suboxone) is considered a well-investigated, highly effective medication-assisted treatment for opiate dependence, but it may only be supervised through the few specialist treatment facilities in the state, or by physicians who have historically been less likely to offer this service. The effectiveness of community physician treatment supervision has not been tested for those in the criminal justice system.
|
Specialist Center
n=10 Participants
Buprenorphine/naloxone via specialist center (B-SC) x 3 months followed by B-PO x 7 months. The specialist center in this trial will be a methadone clinic.
buprenorphine/naloxone: Buprenorphine/naloxone (Suboxone) is considered a well-investigated, highly effective medication-assisted treatment for opiate dependence, but it may only be supervised through the few specialist treatment facilities in the state, or by physicians who have historically been less likely to offer this service. The effectiveness of community physician treatment supervision has not been tested for those in the criminal justice system.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25 years
n=11 Participants
|
22 years
n=10 Participants
|
24 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=11 Participants • One participant in Specialist arm did not enter "Sex" information.
|
3 Participants
n=9 Participants • One participant in Specialist arm did not enter "Sex" information.
|
7 Participants
n=20 Participants • One participant in Specialist arm did not enter "Sex" information.
|
|
Sex: Female, Male
Male
|
7 Participants
n=11 Participants • One participant in Specialist arm did not enter "Sex" information.
|
6 Participants
n=9 Participants • One participant in Specialist arm did not enter "Sex" information.
|
13 Participants
n=20 Participants • One participant in Specialist arm did not enter "Sex" information.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
11 participants
n=11 Participants
|
10 participants
n=10 Participants
|
21 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 2 yearsThe primary outcome will be measured via the publicly available Wisconsin Circuit Court Consolidated Court Automation Program (CCAP) database. The Wisconsin Circuit Court Access website provides access to certain public records of the circuit courts of Wisconsin. The information displayed on the website is an exact copy of the case information entered into CCAP case management system by court staff in the counties where the case files are located. The court record summaries viewed are all public records under Wisconsin open records law and freely accessible to the public. The CCAP database will searched periodically for all enrolled study participants until data analysis has been complete.
Outcome measures
| Measure |
Physician Office
n=11 Participants
Buprenorphine/naloxone via physician office (B-PO) x 10 months
buprenorphine/naloxone: Buprenorphine/naloxone (Suboxone) is considered a well-investigated, highly effective medication-assisted treatment for opiate dependence, but it may only be supervised through the few specialist treatment facilities in the state, or by physicians who have historically been less likely to offer this service. The effectiveness of community physician treatment supervision has not been tested for those in the criminal justice system.
|
Specialist Center
n=10 Participants
Buprenorphine/naloxone via specialist center (B-SC) x 3 months followed by B-PO x 7 months. The specialist center in this trial will be a methadone clinic.
buprenorphine/naloxone: Buprenorphine/naloxone (Suboxone) is considered a well-investigated, highly effective medication-assisted treatment for opiate dependence, but it may only be supervised through the few specialist treatment facilities in the state, or by physicians who have historically been less likely to offer this service. The effectiveness of community physician treatment supervision has not been tested for those in the criminal justice system.
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|---|---|---|
|
Number of Participants With New Crime
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 6 monthsNumber of days from treatment initiation to first drug use thereafter
Outcome measures
| Measure |
Physician Office
n=11 Participants
Buprenorphine/naloxone via physician office (B-PO) x 10 months
buprenorphine/naloxone: Buprenorphine/naloxone (Suboxone) is considered a well-investigated, highly effective medication-assisted treatment for opiate dependence, but it may only be supervised through the few specialist treatment facilities in the state, or by physicians who have historically been less likely to offer this service. The effectiveness of community physician treatment supervision has not been tested for those in the criminal justice system.
|
Specialist Center
n=10 Participants
Buprenorphine/naloxone via specialist center (B-SC) x 3 months followed by B-PO x 7 months. The specialist center in this trial will be a methadone clinic.
buprenorphine/naloxone: Buprenorphine/naloxone (Suboxone) is considered a well-investigated, highly effective medication-assisted treatment for opiate dependence, but it may only be supervised through the few specialist treatment facilities in the state, or by physicians who have historically been less likely to offer this service. The effectiveness of community physician treatment supervision has not been tested for those in the criminal justice system.
|
|---|---|---|
|
Number of Days From Treatment Initiation to First Drug Use
|
24 days
Interval 0.0 to 182.0
|
15 days
Interval 0.0 to 20.0
|
SECONDARY outcome
Timeframe: 6 monthsInitiation of medication assisted treatment (yes/no)
Outcome measures
| Measure |
Physician Office
n=11 Participants
Buprenorphine/naloxone via physician office (B-PO) x 10 months
buprenorphine/naloxone: Buprenorphine/naloxone (Suboxone) is considered a well-investigated, highly effective medication-assisted treatment for opiate dependence, but it may only be supervised through the few specialist treatment facilities in the state, or by physicians who have historically been less likely to offer this service. The effectiveness of community physician treatment supervision has not been tested for those in the criminal justice system.
|
Specialist Center
n=10 Participants
Buprenorphine/naloxone via specialist center (B-SC) x 3 months followed by B-PO x 7 months. The specialist center in this trial will be a methadone clinic.
buprenorphine/naloxone: Buprenorphine/naloxone (Suboxone) is considered a well-investigated, highly effective medication-assisted treatment for opiate dependence, but it may only be supervised through the few specialist treatment facilities in the state, or by physicians who have historically been less likely to offer this service. The effectiveness of community physician treatment supervision has not been tested for those in the criminal justice system.
|
|---|---|---|
|
Initiation of Medication Assisted Treatment
|
11 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: Many subjects did not complete measurement at 6 months: 10 in physician office arm; 5 in specialist arm
The RAB is a self-administered, multiple choice questionnaire. It offers a quick and confidential assessment of both needle sharing practices and sexual activity associated with HIV transmission. The RAB is composed of 45 simple questions which uses discrete response. The questions have different numbers of items, and scores for a single question can range from 0 to 7, with higher values reflecting more instances of risk behavior. The RAB is scored by adding the values that correspond to the responses selected by the subject for the items. This total score is then divided by 40, the highest possible score for the overall instrument, yielding a score from 0 to 1. HIV risk behaviors will be assessed via score on the Risk Assessment Battery at baseline and month 6--difference between baseline and month 6.
Outcome measures
| Measure |
Physician Office
n=1 Participants
Buprenorphine/naloxone via physician office (B-PO) x 10 months
buprenorphine/naloxone: Buprenorphine/naloxone (Suboxone) is considered a well-investigated, highly effective medication-assisted treatment for opiate dependence, but it may only be supervised through the few specialist treatment facilities in the state, or by physicians who have historically been less likely to offer this service. The effectiveness of community physician treatment supervision has not been tested for those in the criminal justice system.
|
Specialist Center
n=5 Participants
Buprenorphine/naloxone via specialist center (B-SC) x 3 months followed by B-PO x 7 months. The specialist center in this trial will be a methadone clinic.
buprenorphine/naloxone: Buprenorphine/naloxone (Suboxone) is considered a well-investigated, highly effective medication-assisted treatment for opiate dependence, but it may only be supervised through the few specialist treatment facilities in the state, or by physicians who have historically been less likely to offer this service. The effectiveness of community physician treatment supervision has not been tested for those in the criminal justice system.
|
|---|---|---|
|
Human Immunodeficiency Virus (HIV) Risk Behavior Assessment by Assessing Change in Risk Assessment Battery (RAB) Score
|
0.01 score on a scale
Interval 0.01 to 0.01
|
0.12 score on a scale
Interval 0.0 to 0.19
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Many participants lost to follow up (9 in physician group, 5 in specialist group) who did not provide 6 month follow up data.
Number of emergency room visits over 6 months
Outcome measures
| Measure |
Physician Office
n=2 Participants
Buprenorphine/naloxone via physician office (B-PO) x 10 months
buprenorphine/naloxone: Buprenorphine/naloxone (Suboxone) is considered a well-investigated, highly effective medication-assisted treatment for opiate dependence, but it may only be supervised through the few specialist treatment facilities in the state, or by physicians who have historically been less likely to offer this service. The effectiveness of community physician treatment supervision has not been tested for those in the criminal justice system.
|
Specialist Center
n=5 Participants
Buprenorphine/naloxone via specialist center (B-SC) x 3 months followed by B-PO x 7 months. The specialist center in this trial will be a methadone clinic.
buprenorphine/naloxone: Buprenorphine/naloxone (Suboxone) is considered a well-investigated, highly effective medication-assisted treatment for opiate dependence, but it may only be supervised through the few specialist treatment facilities in the state, or by physicians who have historically been less likely to offer this service. The effectiveness of community physician treatment supervision has not been tested for those in the criminal justice system.
|
|---|---|---|
|
Number of Emergency Room Visits
|
0 visits
Interval 0.0 to 0.0
|
0.2 visits
Interval 0.0 to 1.0
|
Adverse Events
Physician Office
Specialist Center
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