Treatment for Opioid Dependent Offenders

Study Overview
=================
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.

Official Title
-----------------
Treatment for Opioid Dependent Offenders

Conditions
-----------------
Opioid Dependence

Intervention / Treatment
-----------------
* Drug: Methadone
* Drug: buprenorphine (Suboxone)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: methadone via specialty care<br> | Drug: Methadone<br>* daily for 12 months<br>|
| Other: Suboxone via specialty care<br> | Drug: buprenorphine (Suboxone)<br>* daily for 12 months<br>|
| Other: Suboxone via primary care<br> | Drug: buprenorphine (Suboxone)<br>* daily for 12 months<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
opioid dependent, methadone, Suboxone, buprenorphine