Treatment for Opioid Dependent Offenders
This trial is active, not recruiting.
|Treatments||methadone, buprenorphine (suboxone)|
|Phase||phase 2/phase 3|
|Sponsor||University of Wisconsin, Madison|
|Collaborator||University of Wisconsin, Milwaukee|
|Start date||June 2009|
|End date||February 2011|
|Trial size||16 participants|
|Trial identifier||NCT01082679, RTB-20080242|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
time frame: 12 months
Male or female participants at least 18 years old.
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
|Official title||Treatment for Opioid Dependent Offenders|
|Principal investigator||Randy Brown, MD, PhD|
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