Overview

This trial is active, not recruiting.

Condition opioid dependence
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
methadone
daily for 12 months
(Other)
buprenorphine (suboxone)
daily for 12 months
(Other)
buprenorphine (suboxone)
daily for 12 months

Primary Outcomes

Measure
Effectiveness
time frame: 12 months

Eligibility Criteria

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

Additional Information

Official title Treatment for Opioid Dependent Offenders
Principal investigator Randy Brown, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in March 2010.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.