NCT01082679

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 8, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

June 5, 2023

Status Verified

May 1, 2019

Enrollment Period

1.7 years

First QC Date

March 5, 2010

Last Update Submit

June 2, 2023

Conditions

Opioid Dependence

Keywords

opioid dependentmethadoneSuboxonebuprenorphine

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

methadone via specialty care

OTHER
Drug: Methadone

Suboxone via specialty care

OTHER
Drug: buprenorphine (Suboxone)

Suboxone via primary care

OTHER
Drug: buprenorphine (Suboxone)

Interventions

MethadoneDRUG

daily for 12 months

methadone via specialty care
buprenorphine (Suboxone)DRUG

daily for 12 months

Suboxone via primary careSuboxone via specialty care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin - Madison

Madison, Wisconsin, 53715, United States

Location

Related 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.

    PMID: 23952897RESULT

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

MethadoneBuprenorphineBuprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

KetonesOrganic ChemicalsMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsNaloxoneDrug CombinationsPharmaceutical Preparations

Study Officials

  • Randy Brown, MD, PhD

    University of Wisconsin - Madison, Department of Family Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2010

First Posted

March 8, 2010

Study Start

June 1, 2009

Primary Completion

March 1, 2011

Study Completion

May 1, 2011

Last Updated

June 5, 2023

Record last verified: 2019-05

Locations

US(1)