Treatment for Opioid Dependent Offenders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01082679
Recruitment Status : Unknown
Verified March 2010 by University of Wisconsin, Madison.
Recruitment status was:  Active, not recruiting
First Posted : March 8, 2010
Last Update Posted : March 8, 2010
University of Wisconsin, Milwaukee
Information provided by:
University of Wisconsin, Madison

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 Type : Interventional  (Clinical Trial)
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 : June 2009
Estimated Primary Completion Date : February 2011
Estimated Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Effectiveness [ Time Frame: 12 months ]
    The proposed study will (1) determine feasibility of monitoring Dane County Drug Treatment Court and Treatment Alternative Program participants in primary care as opposed to the usual standard of specialty care; (2) identify barriers to treatment initiation and retention; and (3) foster a multi-disciplinary collaborative treatment model.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01082679

United States, Wisconsin
University of Wisconsin - Madison
Madison, Wisconsin, United States, 53715
Sponsors and Collaborators
University of Wisconsin, Madison
University of Wisconsin, Milwaukee
Principal Investigator: Randy Brown, MD, PhD University of Wisconsin - Madison, Department of Family Medicine

Responsible Party: Randall T. Brown, Principal Investigator, University of Wisconsin - Department of Family Medicine Identifier: NCT01082679     History of Changes
Other Study ID Numbers: RTB-20080242
First Posted: March 8, 2010    Key Record Dates
Last Update Posted: March 8, 2010
Last Verified: March 2010

Keywords provided by University of Wisconsin, Madison:
opioid dependent

Additional relevant MeSH terms:
Analgesics, Opioid
Buprenorphine, Naloxone Drug Combination
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Antitussive Agents
Respiratory System Agents