Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 84 of 186 for:    BUPRENORPHINE AND NALOXONE

Dane County Drug Court Study for Addicted Offenders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01843751
Recruitment Status : Completed
First Posted : May 1, 2013
Results First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Opioid Dependence Drug: buprenorphine/naloxone Phase 3

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Health Promotion and Public Safety: Community-based Collaborative Services to Addicted Offenders
Study Start Date : March 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Physician Office
Buprenorphine/naloxone via physician office (B-PO) x 10 months
Drug: buprenorphine/naloxone
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.
Other Name: Suboxone

Experimental: Specialist Center
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
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.
Other Name: Suboxone




Primary Outcome Measures :
  1. Number of Participants With New Crime [ Time Frame: 2 years ]
    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 Outcome Measures :
  1. Number of Days From Treatment Initiation to First Drug Use [ Time Frame: 6 months ]
    Number of days from treatment initiation to first drug use thereafter

  2. Initiation of Medication Assisted Treatment [ Time Frame: 6 months ]
    Initiation of medication assisted treatment (yes/no)

  3. Human Immunodeficiency Virus (HIV) Risk Behavior Assessment by Assessing Change in Risk Assessment Battery (RAB) Score [ Time Frame: baseline and 6 months ]

    The RAB is a self-administered, multiple choice questionnaire. It offers a quick and confidential assessment of both needle sharing practices and sexual activity associated with HIV transmission.

    The RAB is composed of 45 simple questions which uses discrete response. The questions have different numbers of items, and scores for a single question can range from 0 to 7, with higher values reflecting more instances of risk behavior. The RAB is scored by adding the values that correspond to the responses selected by the subject for the items. This total score is then divided by 40, the highest possible score for the overall instrument, yielding a score from 0 to 1.

    HIV risk behaviors will be assessed via score on the Risk Assessment Battery at baseline and month 6--difference between baseline and month 6.


  4. Number of Emergency Room Visits [ Time Frame: 6 months ]
    Number of emergency room visits over 6 months



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01843751


Locations
Layout table for location information
United States, Wisconsin
University of Wisconsin, Department of Family Medicine
Madison, Wisconsin, United States, 53715
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Layout table for investigator information
Principal Investigator: Randall T Brown, MD, PhD University of Wisconsin, Department of Family Medicine

Layout table for additonal information
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01843751     History of Changes
Other Study ID Numbers: 2012-0226
First Posted: May 1, 2013    Key Record Dates
Results First Posted: March 26, 2019
Last Update Posted: March 26, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Buprenorphine
Buprenorphine, Naloxone Drug Combination
Naloxone
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists