Treatment for Opioid Dependent Offenders

Sponsor

University of Wisconsin, Madison (Other)

Overall Status

Completed

CT.gov ID

NCT01082679

Collaborator

University of Wisconsin, Milwaukee (Other)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Opioid Dependence	Drug: Methadone Drug: buprenorphine (Suboxone)	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Treatment for Opioid Dependent Offenders

Study Start Date :

Jun 1, 2009

Actual Primary Completion Date :

Mar 1, 2011

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: methadone via specialty care	Drug: Methadone daily for 12 months
Other: Suboxone via specialty care	Drug: buprenorphine (Suboxone) daily for 12 months
Other: Suboxone via primary care	Drug: buprenorphine (Suboxone) daily for 12 months

Arm

Intervention/Treatment

Other: methadone via specialty care

Drug: Methadone

daily for 12 months

Other: Suboxone via specialty care

Drug: buprenorphine (Suboxone)

daily for 12 months

Other: Suboxone via primary care

Drug: buprenorphine (Suboxone)

daily for 12 months

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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