Integrating Buprenorphine Into HIV Treatment

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. Identifier: NCT00241930
Recruitment Status : Unknown
Verified August 2005 by Organization to Achieve Solutions in Substance Abuse (OASIS).
Recruitment status was:  Recruiting
First Posted : October 19, 2005
Last Update Posted : October 25, 2005
Information provided by:
Organization to Achieve Solutions in Substance Abuse (OASIS)

October 17, 2005
October 19, 2005
October 25, 2005
September 2005
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  • 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
Same as current
Complete list of historical versions of study NCT00241930 on Archive Site
  • 1. Acceptability of HIV treatment-based buprenorphine therapy
  • 2. Health services utilization
Same as current
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Integrating Buprenorphine Into HIV Treatment
SPNS Buprenorphine and Integrated HIV Care Evaluation and Support Center: Integration of Buprenorphine and HIV Treatment Using the OASIS Model

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.

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.

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Opiate Dependence
  • HIV Infections
Behavioral: Integrating drug treatment into HIV services
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
February 2009
Not Provided

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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
1 H97HA03792-01-00
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Organization to Achieve Solutions in Substance Abuse (OASIS)
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Principal Investigator: Diana L Sylvestre, MD Organization to Achieve Solutions in Substance Abuse (OASIS)
Study Director: Ruth Finkelstein, ScD New York Academy of Medicine
Organization to Achieve Solutions in Substance Abuse (OASIS)
August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP