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Buprenorphine and Integrated HIV Care Evaluation

Primary Purpose

Opioid-Related Disorders, HIV Infections, AIDS

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine
Integrated HIV care and office-based opioid dependence treatment
Sponsored by
The New York Academy of Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-Related Disorders focused on measuring Drug Abuse, Drug Addiction, Drug Dependence, Drug Use Disorders, Drug Use Disorder, Substance Abuse, Substance Use Disorder, Buprenorphine, Opiate Addiction, Substance-related disorders, HIV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: HIV-infected Clinical diagnosis of opioid dependence Fluent in English or Spanish 18 years or older Exclusion Criteria: Liver function tests (transaminase only) at five times or higher than normal level; Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) criteria for benzodiazepine abuse or dependence within the past 6 months; DSM-IV criteria for alcohol dependence within the past 6 months; Actively suicidal; Psychiatric impairment that impedes ability to consent (dementia, delusional, actively psychotic); Methadone dose exceeding levels allowing for safe transition to buprenorphine; Pregnant women and women actively trying to become pregnant; Clinical judgment of local site principal investigator that patient is inappropriate

Sites / Locations

  • El Rio Santa Cruz Neighborhood Health CenterRecruiting
  • Organization to Achieve Solutions in Substance AbuseRecruiting
  • University of California San FranciscoRecruiting
  • Yale University School of Medicine AIDS ProgramRecruiting
  • University of Miami School of MedicineRecruiting
  • The CORE CenterRecruiting
  • Johns Hopkins UniversityRecruiting
  • Montefiore Medical CenterRecruiting
  • Oregon Health & Science UniversityRecruiting
  • The Miriam HospitalRecruiting

Outcomes

Primary Outcome Measures

Substance use outcomes at 1, 3 and 6 months measured by self-report
Urine toxicology results at 1, 3, 6, and 12 months
Retention in and adherence to HIV care at 1, 3, 6, and 12 months

Secondary Outcome Measures

Quality of life at 1, 3, 6, 9, and 12 months
HIV-related health outcomes at 1, 3, 6, 9, and 12 months

Full Information

First Posted
July 25, 2005
Last Updated
March 23, 2007
Sponsor
The New York Academy of Medicine
Collaborators
Health Resources and Services Administration (HRSA), El Rio Santa Cruz Neighborhood Health Center, Organization to Achieve Solutions in Substance Abuse (OASIS), Oregon Health and Science University, Montefiore Medical Center, University of Miami, Brown University, University of California, San Francisco, Johns Hopkins University, CORE Center, Cook County Bureau of Health Services, Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT00124358
Brief Title
Buprenorphine and Integrated HIV Care Evaluation
Official Title
An Evaluation of Innovative Methods for Integrating Buprenorphine Opioid Treatment in HIV Primary Care Settings
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Unknown status
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
The New York Academy of Medicine
Collaborators
Health Resources and Services Administration (HRSA), El Rio Santa Cruz Neighborhood Health Center, Organization to Achieve Solutions in Substance Abuse (OASIS), Oregon Health and Science University, Montefiore Medical Center, University of Miami, Brown University, University of California, San Francisco, Johns Hopkins University, CORE Center, Cook County Bureau of Health Services, Yale University

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to assess the feasibility, cost and effectiveness of interventions designed to integrate buprenorphine treatment for opioid dependence into HIV primary care in ten HIV care centers in the U.S.
Detailed Description
Programs that integrate medical care and drug treatment have shown great promise in improving health and substance use related outcomes. The overlap in the epidemics of HIV (with its complex medical needs) and drug abuse makes HIV-infected drug users a population likely to benefit from the integration of primary care and drug treatment. The Drug Addiction Treatment Act of 2000 and the approval of buprenorphine for the office-based treatment of opioid addiction provide a new opportunity to integrate addiction treatment and medical care for people with HIV. Research has demonstrated the effectiveness of buprenorphine in reducing illicit drug use among opioid dependent people. However, little is known about implementing such programs in HIV care settings, their cost, what effect they have on the health outcomes and substance use behavior of PLWH/A, or their broader impact on providers, institutions, and local systems. Through this study, approximately 1,350 HIV-infected individuals who meet criteria for opioid dependence will be selected by eleven model demonstration projects located in ten HIV care centers across the U.S. Information on patients' drug use, HIV health status, service utilization, quality of life, and satisfaction with services as well as information about providers' practices and attitudes towards treating drug dependent patients will be collected through face-to-face interviews, audio computer-assisted self-interviewing, written surveys, and chart abstractions. These data will be used to help replicate effective programs that integrated HIV care and drug treatment and to improve the care of HIV-infected opioid dependent individuals. Comparisons: All eleven programs will compare a group of patients who receive integrated buprenorphine treatment and HIV care to a group of patients who receive an alternate intervention. However, the program designs and comparison group interventions vary across the sites and are locally determined. Some sites will implement randomized control designs, while others will use observational methods.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders, HIV Infections, AIDS
Keywords
Drug Abuse, Drug Addiction, Drug Dependence, Drug Use Disorders, Drug Use Disorder, Substance Abuse, Substance Use Disorder, Buprenorphine, Opiate Addiction, Substance-related disorders, HIV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1350 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Buprenorphine
Intervention Type
Behavioral
Intervention Name(s)
Integrated HIV care and office-based opioid dependence treatment
Primary Outcome Measure Information:
Title
Substance use outcomes at 1, 3 and 6 months measured by self-report
Title
Urine toxicology results at 1, 3, 6, and 12 months
Title
Retention in and adherence to HIV care at 1, 3, 6, and 12 months
Secondary Outcome Measure Information:
Title
Quality of life at 1, 3, 6, 9, and 12 months
Title
HIV-related health outcomes at 1, 3, 6, 9, and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV-infected Clinical diagnosis of opioid dependence Fluent in English or Spanish 18 years or older Exclusion Criteria: Liver function tests (transaminase only) at five times or higher than normal level; Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) criteria for benzodiazepine abuse or dependence within the past 6 months; DSM-IV criteria for alcohol dependence within the past 6 months; Actively suicidal; Psychiatric impairment that impedes ability to consent (dementia, delusional, actively psychotic); Methadone dose exceeding levels allowing for safe transition to buprenorphine; Pregnant women and women actively trying to become pregnant; Clinical judgment of local site principal investigator that patient is inappropriate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruth Finkelstein, ScD
Phone
212.822.7266
Email
rfinkelstein@nyam.org
First Name & Middle Initial & Last Name or Official Title & Degree
James E Egan, MPH
Phone
212.822.7347
Email
jegan@nyam.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruth Finkelstein, ScD
Organizational Affiliation
New York Academy of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Fiellin, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
El Rio Santa Cruz Neighborhood Health Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85745
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeff Thomas, ACSW
Phone
520-629-2888
Email
jefft@elrio.org
First Name & Middle Initial & Last Name & Degree
Kevin Carmichael, MD
Facility Name
Organization to Achieve Solutions in Substance Abuse
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laphyne Barrett, MA
Phone
510-834-5442
First Name & Middle Initial & Last Name & Degree
Diana Sylvestre
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bob Thawley
Phone
415-476-9296
Ext
311
Email
rthawley@php.ucsf.edu
First Name & Middle Initial & Last Name & Degree
Paula Lum, MD, MPH
First Name & Middle Initial & Last Name & Degree
Jacqueline Tulsky, MD
Facility Name
Yale University School of Medicine AIDS Program
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Declan Barry, PhD
Phone
203-781-4650
Ext
250
Email
declan.barry@yale.edu
First Name & Middle Initial & Last Name & Degree
Frederick Altice, MD
First Name & Middle Initial & Last Name & Degree
Lynn Sullivan, MD
Facility Name
University of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leslie Thompson, RN, BSN
Phone
305-243-3838
Email
lthomps@gate.net
First Name & Middle Initial & Last Name & Degree
Margaret Fischl, MD
First Name & Middle Initial & Last Name & Degree
Lisa Metsch, PhD
Facility Name
The CORE Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Jo Tozzi
Phone
312-572-4818
Email
mtozzi@corecenter.org
First Name & Middle Initial & Last Name & Degree
Jeffrey Watts, MD
First Name & Middle Initial & Last Name & Degree
David Barker, MD
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Greg Lucas, MD, PhD
Phone
410-614-0560
Email
glucas@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Greg Lucas, MD, PhD
First Name & Middle Initial & Last Name & Degree
Yngveld Olsen, MD
First Name & Middle Initial & Last Name & Degree
William Ruby, DO
First Name & Middle Initial & Last Name & Degree
Jeffrey Hsu, MD
First Name & Middle Initial & Last Name & Degree
Jeanne Keruly, CRNP
First Name & Middle Initial & Last Name & Degree
Richard Moore, MD
Facility Name
Montefiore Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Galit Sacajiu, MD
Email
gsacajiu@montefiore.org
First Name & Middle Initial & Last Name & Degree
Chinazo Cunningham, MD
First Name & Middle Initial & Last Name & Degree
Nancy Sohler, PhD, MPH
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Pedersen, MPA
Phone
503-494-6770
First Name & Middle Initial & Last Name & Degree
P. Todd Korthuis, MD, MPH
First Name & Middle Initial & Last Name & Degree
Dennis McCarty, PhD
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helen Loewenthal, MSW
Phone
401-793-4824
Email
hloewenthal@lifespan.org
First Name & Middle Initial & Last Name & Degree
Timothy Flanigan, MD
First Name & Middle Initial & Last Name & Degree
Peter Friedman, MD, MPH

12. IPD Sharing Statement

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Buprenorphine and Integrated HIV Care Evaluation

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