Skip to content

Treatment for Opioid Dependent Offenders

Treatment for Opioid Dependent Offenders

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01082679
Enrollment
16
Registered
2010-03-08
Start date
2009-06-30
Completion date
2011-05-31
Last updated
2023-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Dependence

Keywords

opioid dependent, methadone, Suboxone, buprenorphine

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.

Interventions

DRUGMethadone

daily for 12 months

DRUGbuprenorphine (Suboxone)

daily for 12 months

Sponsors

University of Wisconsin, Milwaukee
CollaboratorOTHER
University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Retention rate of participants in the study12 monthsThis 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026