Treatment for Opioid Dependent Offenders

Phase 2

Completed

• Conditions: Opioid Dependence
• Interventions: Drug: buprenorphine (Suboxone); Drug: Methadone

• Registration Number: NCT01082679
• Lead Sponsor: University of Wisconsin, Madison

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2010-03-05
• Study First Submitted QC: 2010-03-05
• Study First Posted: 2010-03-08
• Primary Completion: 2011-03
• Study Completion: 2011-05
• Status Verified: 2019-05
• Last Update Submitted: 2023-06-02
• Last Update Posted: 2023-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Suboxone via specialty care	buprenorphine (Suboxone)	-
Suboxone via primary care	buprenorphine (Suboxone)	-
methadone via specialty care	Methadone	-

Primary Outcome Measures

Name	Time	Method
Retention rate of participants in the study	12 months	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

Trial Locations

Locations (1)

University of Wisconsin - Madison; 🇺🇸 Madison, Wisconsin, United States