Treatment for Opioid Dependent Offenders

Opioid Dependence Clinical Trial

Official title:

Treatment for Opioid Dependent Offenders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01082679
• Other study ID #: H-2008-0242
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 2009
• Est. completion date: May 2011

Study information

• Verified date: May 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Dependence
• Opioid-Related Disorders

Intervention

Drug:
• Methadone
daily for 12 months
• buprenorphine (Suboxone)
daily for 12 months

Locations

Country	Name	City	State
United States	University of Wisconsin - Madison	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	University of Wisconsin, Milwaukee

Country where clinical trial is conducted

United States, 

References & Publications (1)

Brown R, Gassman M, Hetzel S, Berger L. Community-based treatment for opioid dependent offenders: a pilot study. Am J Addict. 2013 Sep-Oct;22(5):500-2. doi: 10.1111/j.1521-0391.2013.12049.x. Epub 2013 Apr 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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