Dane County Drug Court Study for Addicted Offenders

Addiction adversely affects individual and family well-being, public health, and public
safety across the state of WI. Appropriate treatment can prevent myriad physical consequences
of addiction, such as HIV, viral hepatitis, endocarditis, motor vehicle accidents and other
trauma. Treatment to one addicted individual prevents 63 crimes per year—not including
intimate partner and child abuse, which remain under-reported. An individual's contact with
the WI criminal justice system constitutes a critical point for referral into supervised
treatment to promote the recovery of the user and, hence, public health and safety. This
project and related future work will help optimize prevention, intervention, and policy
development targeting substance use, crime and related consequences. Specifically, the
proposed work will 1) examine the impact of collaborative community treatment models
involving generalist physician offices, specialist treatment facilities, and criminal
justice, 2) examine HIV risk behaviors and their response to study conditions, and 3)
disseminate results to state and national audiences to promote collaboration between criminal
justice, specialist care, and generalist health care in reducing drug-related harms to
individual and population health. There is a high prevalence of opiate dependence among the
criminally involved. 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.

The proposed project seeks to test models to expand treatment access for substance dependent
individuals. The project builds logically upon previous work by the PI. Substance dependent
offenders are specifically chosen for investigation due to (1) the greater severity and
prevalence of substance use problems and complications when compared to the more general
adult substance-dependent population, (2) the impact of drug-related criminal behavior upon
victims and upon the safety and well-being of our communities, and (3) the suitability of our
team and community-based collaborators to conduct research with addicted offenders in order
to promote individual recovery, public health, and public safety.

To contribute to knowledge regarding potential models for the expansion of treatment and
supervision for substance dependent offenders, the current project and related future work
will aim to:

1. Compare models of treatment involving (1) specialist-directed treatment followed by
physician-office based treatment, and (2) physician-office-based treatment alone.

2. Determine if and to what degree a period of stabilization with specialist-directed
treatment improves outcomes over physician-office-based treatment alone.

3. Clarify the optimal period of time for such a period of "specialist stabilization."

In this study, "stabilization" refers to a period of time at the front end of treatment
during which the addicted offender participates in a more stringent set of supervisory
conditions tied to their medication dispensing. This includes daily reporting for medication
dosing and more frequent urine drug testing.

The primary study outcome will be time to commission of 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.

Secondary outcomes include ongoing drug use as measured by urine drug testing, previously
validated self-report measures; and treatment uptake and adherence. Secondary outcomes also
include standardized measures of HIV risk behaviors, health services utilization, and cost
benefit (societal perspective).

All subjects will be recruited via Journey Mental Health Center (formerly Mental Health
Center of Dane County), which serves as the assessment unit for the Dane County Drug
Treatment Court (DTC). This study will determine whether varying periods of initial
stabilization in specialist treatment affects outcomes vs. physician-office treatment alone.
The study will randomize 40 participants to one of 2 conditions characterized by the duration
or lack of the "specialist stabilization period": 1) buprenorphine/naloxone via physician
office (B-PO) x 10 months, or 2) buprenorphine/naloxone via specialist center (B-SC) x 3
months followed by B-PO x 7 months. Subjects will receive behavioral treatment and court
supervision as usual. The primary outcome will be time to re-arrest/new crime. Secondary
outcomes include ongoing drug use measured by 1) urine drug testing, and 2) validated
self-report measures, treatment uptake and adherence, standardized measures of HIV risk
behaviors, health services utilization, and cost benefit.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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 (

- Specific medical conditions, to be identified via initial medical history and
examination, which would necessitate exclusion from study participation include:
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.