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Trial record 84 of 186 for:    BUPRENORPHINE AND NALOXONE

Dane County Drug Court Study for Addicted Offenders

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ClinicalTrials.gov Identifier: NCT01843751
Recruitment Status : Completed
First Posted : May 1, 2013
Results First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Opioid Dependence
Intervention Drug: buprenorphine/naloxone
Enrollment 24
Recruitment Details  
Pre-assignment Details Initially 24 participants consented,but 3 did not receive intervention or provide data, so only 21 participants were analyzed out of 24 enrolled.
Arm/Group Title Physician Office Specialist Center
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 11 10
Completed 0 3
Not Completed 11 7
Arm/Group Title Physician Office Specialist Center Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 11 10 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 11 participants 10 participants 21 participants
25
(17 to 43)
22
(17 to 41)
24
(17 to 43)
Sex: Female, Male   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 9 participants 20 participants
Female
4
  36.4%
3
  33.3%
7
  35.0%
Male
7
  63.6%
6
  66.7%
13
  65.0%
[1]
Measure Description: One participant in "Specialist Center" arm did not provide Sex.
[2]
Measure Analysis Population Description: One participant in Specialist arm did not enter "Sex" information.
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 10 participants 21 participants
11 10 21
1.Primary Outcome
Title Number of Participants With New Crime
Hide Description 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.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Physician Office Specialist Center
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
5
  45.5%
3
  30.0%
2.Secondary Outcome
Title Number of Days From Treatment Initiation to First Drug Use
Hide Description Number of days from treatment initiation to first drug use thereafter
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Physician Office Specialist Center
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 11 10
Mean (Full Range)
Unit of Measure: days
24
(0 to 182)
15
(0 to 20)
3.Secondary Outcome
Title Initiation of Medication Assisted Treatment
Hide Description Initiation of medication assisted treatment (yes/no)
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Physician Office Specialist Center
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
11
 100.0%
10
 100.0%
4.Secondary Outcome
Title Human Immunodeficiency Virus (HIV) Risk Behavior Assessment by Assessing Change in Risk Assessment Battery (RAB) Score
Hide Description

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.

Time Frame baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Many subjects did not complete measurement at 6 months: 10 in physician office arm; 5 in specialist arm
Arm/Group Title Physician Office Specialist Center
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 1 5
Mean (Full Range)
Unit of Measure: score on a scale
0.01
(0.01 to 0.01)
0.12
(0 to 0.19)
5.Secondary Outcome
Title Number of Emergency Room Visits
Hide Description Number of emergency room visits over 6 months
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Many participants lost to follow up (9 in physician group, 5 in specialist group) who did not provide 6 month follow up data.
Arm/Group Title Physician Office Specialist Center
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 2 5
Mean (Full Range)
Unit of Measure: visits
0
(0 to 0)
0.2
(0 to 1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Physician Office Specialist Center
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Physician Office Specialist Center
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Physician Office Specialist Center
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Physician Office Specialist Center
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/10 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Randall Brown
Organization: University of Wisconsin
Phone: 608-263-6558
EMail: rtbrown@wisc.edu
Layout table for additonal information
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01843751     History of Changes
Other Study ID Numbers: 2012-0226
First Submitted: April 17, 2013
First Posted: May 1, 2013
Results First Submitted: February 4, 2019
Results First Posted: March 26, 2019
Last Update Posted: March 26, 2019