The CORE Buprenorphine Project - An HIV Primary Care Program Demonstration
Summary
The goal of this study is to develop and evaluate an innovative model of care to better serve patients who are both HIV-infected and opioid-dependent.
Description
Hypothesis: HIV, opioid dependent patients provided agonist therapy at the site of their primary care will have better retention, utilization of services, health, social and quality of care measures and psychiatric treatment outcomes.
The Buprenorphine Project is an examination of two methods of service delivery. The purpose of this study is to assess the feasibility, cost and effectiveness of an intervention designed to integrate buprenorphine treatment for opioid dependence into HIV primary care at the CORE Center. For this project we will provide buprenorphine to 60 opioid dependent patients at any one time and will compare this on-site treatment group to 60 opioid dependent HIV+ patients who select off-site methadone or no agonist treatment at the time of enrollment.
Study Design
Time Perspective: Prospective
Conditions
HIV Infections
Intervention
On-site - buprenorphine/naloxone (Suboxone), Off-site - methadone or no agonist
Location
The CORE Center
Chicago
Illinois
United States
60612
Status
Completed
Source
Ruth M. Rothstein CORE Center
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00227357
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Buprenorphine
A derivative of the opioid alkaloid THEBAINE that is a more potent and longer lasting analgesic than MORPHINE. It appears to act as a partial agonist at mu and kappa opioid receptors and as an antagonist at delta receptors. The lack of delta-agonist activity has been suggested to account for the observation that buprenorphine tolerance may not develop with chronic use.
Methadone
A synthetic opioid that is used as the hydrochloride. It is an opioid analgesic that is primarily a mu-opioid agonist. It has actions and uses similar to those of MORPHINE. It also has a depressant action on the cough center and may be given to control intractable cough associated with terminal lung cancer. Methadone is also used as part of the treatment of dependence on opioid drugs, although prolonged use of methadone itself may result in dependence. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1082-3)
Opiate Substitution Treatment
Medical treatment for opioid dependence using a substitute opiate such as METHADONE or BUPRENORPHINE.
Ribosome Subunits, Small
The small ribonucleoprotein component of RIBOSOMES. It contains the MESSENGER RNA binding site and two TRANSFER RNA binding sites - one for the incoming AMINO ACYL TRNA (A site) and the other (P site) for the peptidyl tRNA carrying the elongating peptide chain.
Leukemic Infiltration
A pathologic change in leukemia in which leukemic cells permeate various organs at any stage of the disease. All types of leukemia show various degrees of infiltration, depending upon the type of leukemia. The degree of infiltration may vary from site to site. The liver and spleen are common sites of infiltration, the greatest appearing in myelocytic leukemia, but infiltration is seen also in the granulocytic and lymphocytic types. The kidney is also a common site and of the gastrointestinal system, the stomach and ileum are commonly involved. In lymphocytic leukemia the skin is often infiltrated. The central nervous system too is a common site.
Clinical Trials
Patients who admit to using buprenorphine by the intravenous route will be randomized to either Subutex or Suboxone and be followed up for 3 months to determine if there is less injection...
Starting Treatment With Agonist Replacement Therapies (START)
The Food and Drug Administration (FDA) has requested a study comparing buprenorphine/naloxone (BUP/NX) and methadone (MET) on indices of hepatic safety.
The aim of this post marketing surveillance study is to investigate the retention rate after 12 months of substitution treatment with SUBOXONE® (buprenorphine plus naloxone) of opioid dep...
Suboxone: (Buprenorphine/Naloxone) Comparison of Two Taper Schedules - 1
The purpose of this protocol is to to compare the clinical utility of two dosage tapering regimens in Buprenorphine/Naloxone stabilized subjects for opiate detoxification.
The purpose of this study is to evaluate the acceptibility and safety of switching to buprenorphine/naloxone (Suboxone®) and the effect of the switch on medication dispensing. Subjects wi...
PubMed Articles
The sublingual combination of buprenorphine and naloxone (Suboxone(®)) and Methadone Maintenance Therapy have been found effective in treating heroin addiction. A new analytical method suitable for t...
Methadone and buprenorphine are used in maintenance therapy for heroin addicts. In this study, we compared their effects on adenylate cyclase (AC) activity in human embryonic kidney (HEK) 293 cells st...
The SUMMIT Trial: A field comparison of buprenorphine versus methadone maintenance treatment.
This prospective patient-preference study examined the effectiveness in practice of methadone versus buprenorphine maintenance treatment and the beliefs of subjects regarding these drugs. A total of 3...
Buprenorphine (Subutex) and buprenorphine/naloxone (Suboxone) received Food and Drug Administration approval in 2002 for the treatment of opioid dependence. Introduction of these drugs expanded the av...
Implementing integrated HIV and buprenorphine/naloxone treatment requires cost estimates to plan and obtain funding.
