Dane County Drug Court Study for Addicted Offenders

NCT01843751 | Completed Phase 3 Results

• 1 other identifier: 2012-0226
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed work addresses critical health and public safety issues in the U.S. and in Wisconsin: the intersection of addiction and crime and the prevention of associated individual and public health complications. The results will provide justification for the expanded involvement of primary care in the treatment of substance-related disorders (opioid dependence in particular) and the prevention of their complications. As such, the project answers to federal calls for the expansion of substance abuse treatment into primary care settings and to objectives within the Alcohol and Drug Focus Area of Healthiest Wisconsin 2020.

Conditions

Opioid Dependence

Outcome Measures

Primary Outcomes (1)

• Number of Participants With New Crime

  The primary outcome will be measured via the publicly available Wisconsin Circuit Court Consolidated Court Automation Program (CCAP) database. The Wisconsin Circuit Court Access website provides access to certain public records of the circuit courts of Wisconsin. The information displayed on the website is an exact copy of the case information entered into CCAP case management system by court staff in the counties where the case files are located. The court record summaries viewed are all public records under Wisconsin open records law and freely accessible to the public. The CCAP database will searched periodically for all enrolled study participants until data analysis has been complete.

  2 years

Secondary Outcomes (4)

• Number of Days From Treatment Initiation to First Drug Use

  6 months

• Initiation of Medication Assisted Treatment

  6 months

• Human Immunodeficiency Virus (HIV) Risk Behavior Assessment by Assessing Change in Risk Assessment Battery (RAB) Score

  baseline and 6 months

• Number of Emergency Room Visits

  6 months

Study Arms (2)

Physician Office

ACTIVE COMPARATOR

Buprenorphine/naloxone via physician office (B-PO) x 10 months

Drug: buprenorphine/naloxone

Specialist Center

EXPERIMENTAL

Buprenorphine/naloxone via specialist center (B-SC) x 3 months followed by B-PO x 7 months. The specialist center in this trial will be a methadone clinic.

Drug: buprenorphine/naloxone

Interventions

buprenorphine/naloxone DRUG

Buprenorphine/naloxone (Suboxone) is considered a well-investigated, highly effective medication-assisted treatment for opiate dependence, but it may only be supervised through the few specialist treatment facilities in the state, or by physicians who have historically been less likely to offer this service. The effectiveness of community physician treatment supervision has not been tested for those in the criminal justice system.

Also known as: Suboxone

Physician Office; Specialist Center

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Enrollment in the Drug Treatment Court
• diagnosis of opioid dependence using the Addiction Severity Index-Lite and diagnosis by clinical staff of referring units
• opioid positive urine drug screen at baseline
• women of childbearing potential who have a negative screening urine pregnancy test and are willing to use reliable birth control methods throughout the duration of the study.

You may not qualify if:

• pregnancy
• women who are currently breastfeeding
• complex psychiatric co-morbidity (e.g. suicidality, psychosis)
• complex medical co-morbidity (e.g. major cardiovascular, renal, or gastrointestinal/hepatic disease)
• or current pharmacotherapy with an agent which is contraindicated in combination with buprenorphine/naloxone according to drug labeling (

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin, Department of Family Medicine

Madison, Wisconsin, 53715, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Buprenorphine; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Naloxone; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Randall Brown
• Organization: University of Wisconsin

rtbrown@wisc.edu

608-263-6558

Study Officials

• Randall T Brown, MD, PhD

  University of Wisconsin, Department of Family Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2013
• First Posted: May 1, 2013
• Study Start: March 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: June 7, 2023
• Results First Posted: March 26, 2019

Record last verified: 2019-03

Locations

US (1)