Treatment for Opioid Dependent Offenders

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by University of Wisconsin, Madison.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University of Wisconsin, Milwaukee
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01082679
First received: March 5, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose

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 Intervention Phase
Opioid Dependence
Drug: Methadone
Drug: buprenorphine (Suboxone)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment for Opioid Dependent Offenders

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Effectiveness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 16
Study Start Date: June 2009
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01082679

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

No publications provided

Responsible Party: Randall T. Brown, Principal Investigator, University of Wisconsin - Department of Family Medicine
ClinicalTrials.gov Identifier: NCT01082679     History of Changes
Other Study ID Numbers: RTB-20080242
Study First Received: March 5, 2010
Last Updated: March 5, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
opioid dependent
methadone
Suboxone
buprenorphine

Additional relevant MeSH terms:
Buprenorphine
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotic Antagonists
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 18, 2014