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Treatment for Opioid Dependent Offenders

Primary Purpose

Opioid Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Methadone
buprenorphine (Suboxone)
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Dependence focused on measuring opioid dependent, methadone, Suboxone, buprenorphine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of opioid dependence
  • opioid positive urine drug screen
  • participation in local Drug Treatment Court or Treatment Alternative Program
  • women of childbearing potential who have a negative screening urine pregnancy test and are willing to use appropriate birth control methods during the duration of the study

Exclusion Criteria:

  • current alcohol or sedative dependence
  • pregnancy
  • women who are currently breast-feeding
  • complex psychiatric co-morbidity (e.g. suicidality, psychosis)
  • complex medical co-morbidity (e.g. major cardiovascular, renal, or gastrointestinal/hepatic disease)
  • current pharmacotherapy with an agent which is contraindicated in combination with Suboxone or methadone according to drug labeling
  • paralytic ileus, coronary artery disease or heart arrhythmia, recent head injury, obstructive sleep apnea, severe asthma or COPD, end-stage renal disease, or severe morbid obesity

Sites / Locations

  • University of Wisconsin - Madison

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

methadone via specialty care

Suboxone via specialty care

Suboxone via primary care

Arm Description

Outcomes

Primary Outcome Measures

Retention rate of participants in the study
This study is focused on Dane County Drug Treatment Court and Treatment Alternative Program participants. The study will determine feasibility of monitoring participants in primary care as opposed to the usual standard of specialty care. Feasibility of monitoring participants will be studied in terms of retention rate of participants in the study

Secondary Outcome Measures

Full Information

First Posted
March 5, 2010
Last Updated
June 2, 2023
Sponsor
University of Wisconsin, Madison
Collaborators
University of Wisconsin, Milwaukee
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1. Study Identification

Unique Protocol Identification Number
NCT01082679
Brief Title
Treatment for Opioid Dependent Offenders
Official Title
Treatment for Opioid Dependent Offenders
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
University of Wisconsin, Milwaukee

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This pilot study is examining the feasibility of a primary care and a specialist treatment (methadone clinic) model of treatment for 15 offenders who are part of two community supervision programs: Drug Court and the Treatment Alternative Program (TAP) in Dane County. The questions addressed by future larger studies based upon the current pilot-feasibility study will center around whether access to primary health care as opposed to more traditional methadone treatment services will improve the health and criminal justice outcomes for participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Dependence
Keywords
opioid dependent, methadone, Suboxone, buprenorphine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
methadone via specialty care
Arm Type
Other
Arm Title
Suboxone via specialty care
Arm Type
Other
Arm Title
Suboxone via primary care
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Methadone
Intervention Description
daily for 12 months
Intervention Type
Drug
Intervention Name(s)
buprenorphine (Suboxone)
Intervention Description
daily for 12 months
Primary Outcome Measure Information:
Title
Retention rate of participants in the study
Description
This study is focused on Dane County Drug Treatment Court and Treatment Alternative Program participants. The study will determine feasibility of monitoring participants in primary care as opposed to the usual standard of specialty care. Feasibility of monitoring participants will be studied in terms of retention rate of participants in the study
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of opioid dependence opioid positive urine drug screen participation in local Drug Treatment Court or Treatment Alternative Program women of childbearing potential who have a negative screening urine pregnancy test and are willing to use appropriate birth control methods during the duration of the study Exclusion Criteria: current alcohol or sedative dependence pregnancy women who are currently breast-feeding complex psychiatric co-morbidity (e.g. suicidality, psychosis) complex medical co-morbidity (e.g. major cardiovascular, renal, or gastrointestinal/hepatic disease) current pharmacotherapy with an agent which is contraindicated in combination with Suboxone or methadone according to drug labeling paralytic ileus, coronary artery disease or heart arrhythmia, recent head injury, obstructive sleep apnea, severe asthma or COPD, end-stage renal disease, or severe morbid obesity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randy Brown, MD, PhD
Organizational Affiliation
University of Wisconsin - Madison, Department of Family Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin - Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23952897
Citation
Brown R, Gassman M, Hetzel S, Berger L. Community-based treatment for opioid dependent offenders: a pilot study. Am J Addict. 2013 Sep-Oct;22(5):500-2. doi: 10.1111/j.1521-0391.2013.12049.x. Epub 2013 Apr 3.
Results Reference
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Treatment for Opioid Dependent Offenders

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