Phase 3
N=21
Dane County Drug Court Study for Addicted Offenders
Opioid Dependence
Bottom Line
View on ClinicalTrials.gov: NCT01843751 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Number of Participants With New Crime — 5; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- buprenorphine/naloxone (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With New Crime |
5; 3 | — |
| SECONDARY Number of Days From Treatment Initiation to First Drug Use |
24; 15 | — |
| SECONDARY Initiation of Medication Assisted Treatment |
11; 10 | — |
| SECONDARY Human Immunodeficiency Virus (HIV) Risk Behavior Assessment by Assessing Change in Risk Assessment Battery (RAB) Score |
0.01; 0.12 | — |
| SECONDARY Number of Emergency Room Visits |
0; 0.2 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01843751). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.