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Integrating Buprenorphine Into HIV Treatment

Primary Purpose

Opiate Dependence, HIV Infections

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Integrating drug treatment into HIV services
Sponsored by
Organization to Achieve Solutions in Substance Abuse (OASIS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opiate Dependence focused on measuring Heroin, HIV, buprenorphine, integration, drug treatment

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: HIV+ as verified by lab report DSM-IV diagnosis of opioid dependence Speaks/understands English Age 18 years or older Exclusion Criteria: LFT's (transaminase) >5x ULN DSV-IV criteria for benzodiazepine abuse or dependence within the last month DSM-IV criteria for alcohol dependence within the past 6 months Actively suicidal Methadone dose exceeds level allowing safe transition to buprenorphine Pregnant women and women trying to become pregnant Unable to provide informed consent Clinical judgement that patient is inappropriate

Sites / Locations

  • Alameda County Medical Center HIV ClinicRecruiting
  • OASISRecruiting
  • Fairmont Hospital HIV ClinicRecruiting

Outcomes

Primary Outcome Measures

1.Impact of integrated care vs nonintegrated care on:
a. Substance use and high-risk transmission behaviors
b. Medical engagement and outcomes
c. Psychosocial indices, such as criminal justice, employment, housing, and education

Secondary Outcome Measures

1. Acceptability of HIV treatment-based buprenorphine therapy
2. Health services utilization

Full Information

First Posted
October 17, 2005
Last Updated
October 24, 2005
Sponsor
Organization to Achieve Solutions in Substance Abuse (OASIS)
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1. Study Identification

Unique Protocol Identification Number
NCT00241930
Brief Title
Integrating Buprenorphine Into HIV Treatment
Official Title
SPNS Buprenorphine and Integrated HIV Care Evaluation and Support Center: Integration of Buprenorphine and HIV Treatment Using the OASIS Model
Study Type
Interventional

2. Study Status

Record Verification Date
August 2005
Overall Recruitment Status
Unknown status
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2009 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Organization to Achieve Solutions in Substance Abuse (OASIS)

4. Oversight

5. Study Description

Brief Summary
We hypothesize that integrating drug treatment into HIV treatment will improve HIV outcomes as well as drug treatment outcomes in heroin users. This study will test this hypothesis by randomizing patients to two groups. The first group will receive HIV treatment and buprenorphine treatment contemporaneously at their HIV clinic. The second group will receive HIV treatment at their HIV clinic, and go to another facility to receive buprenorphine treatment services. We will look at HIV outcomes such as CD4 counts, HIV viral loads, and attendance at appointments and drug treatment outcomes such as receipt of buprenorphine and urine toxicology testing.
Detailed Description
This study will test the hypothesis that integrating buprenorphine within the context of primary care HIV treatment will improve outcomes for HIV-infected heroin users vs providing buprenorphine services at a separate, off-site facility. As a means of engagement, we will offer the OASIS education group each week at each facility. For those randomized to integrated care, subjects will attend one education session weekly at the time of their HIV clinic. During these sessions, subjects will receive contemporaneous HIV clinic appointments (monthly), case management (monthly), drug counseling (twice monthly), and buprenorphine (which will be dispensed weekly.) For those randomized to separate care, subjects will attend HIV clinic appointments monthly, and will attend weekly education sessions at the OASIS facility. During these sessions, subjects will receive weekly buprenorphine, twice monthly drug counseling, and monthly case management. We will measure outcomes by reporting attendance, CD4 counts, HIV viral loads, urine toxicology testing on at least a quarterly basis. We will also measure patient satisfaction, knowledge, quality of life, and a number of other outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Dependence, HIV Infections
Keywords
Heroin, HIV, buprenorphine, integration, drug treatment

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Integrating drug treatment into HIV services
Primary Outcome Measure Information:
Title
1.Impact of integrated care vs nonintegrated care on:
Title
a. Substance use and high-risk transmission behaviors
Title
b. Medical engagement and outcomes
Title
c. Psychosocial indices, such as criminal justice, employment, housing, and education
Secondary Outcome Measure Information:
Title
1. Acceptability of HIV treatment-based buprenorphine therapy
Title
2. Health services utilization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV+ as verified by lab report DSM-IV diagnosis of opioid dependence Speaks/understands English Age 18 years or older Exclusion Criteria: LFT's (transaminase) >5x ULN DSV-IV criteria for benzodiazepine abuse or dependence within the last month DSM-IV criteria for alcohol dependence within the past 6 months Actively suicidal Methadone dose exceeds level allowing safe transition to buprenorphine Pregnant women and women trying to become pregnant Unable to provide informed consent Clinical judgement that patient is inappropriate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diana L Sylvestre, MD
Phone
510-834-5442
Email
dsylves@itsa.ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Laphyne Barrett
Phone
510-834-5442
Email
oasisclinic@sbcglobal.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana L Sylvestre, MD
Organizational Affiliation
Organization to Achieve Solutions in Substance Abuse (OASIS)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ruth Finkelstein, ScD
Organizational Affiliation
New York Academy of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Alameda County Medical Center HIV Clinic
City
Oakland
State/Province
California
ZIP/Postal Code
94602
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lance Smith
Phone
510-437-4888
First Name & Middle Initial & Last Name & Degree
Silver Sisneros, MD
Phone
510-437-4891
Email
ssisneros@acmedctr.org
First Name & Middle Initial & Last Name & Degree
Silver Sisneros, DO
Facility Name
OASIS
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
Phone
510-834-5442
Email
oasisclinic@sbcglobal.net
First Name & Middle Initial & Last Name & Degree
Diana L Sylvestre, MD
Facility Name
Fairmont Hospital HIV Clinic
City
San Leandro
State/Province
California
ZIP/Postal Code
94578
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lance Smith
Phone
510-437-4888
First Name & Middle Initial & Last Name & Degree
Beth Schweitzer, MD
Phone
510-667-3201
First Name & Middle Initial & Last Name & Degree
Beth Schweitzer, MD

12. IPD Sharing Statement

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Integrating Buprenorphine Into HIV Treatment

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