Treatment for Opioid Dependent Offenders

NCT ID: NCT01082679

Last Updated: 2023-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Opioid Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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methadone via specialty care

Group Type OTHER

Methadone

Intervention Type DRUG

daily for 12 months

Suboxone via specialty care

Group Type OTHER

buprenorphine (Suboxone)

Intervention Type DRUG

daily for 12 months

Suboxone via primary care

Group Type OTHER

buprenorphine (Suboxone)

Intervention Type DRUG

daily for 12 months

Interventions

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Methadone

daily for 12 months

Intervention Type DRUG

buprenorphine (Suboxone)

daily for 12 months

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Milwaukee

OTHER

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Randy Brown, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin - Madison, Department of Family Medicine

Locations

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University of Wisconsin - Madison

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 23952897 (View on PubMed)

Other Identifiers

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H-2008-0242

Identifier Type: -

Identifier Source: org_study_id

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