Integrating Buprenorphine Into HIV Treatment
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ClinicalTrials.gov 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
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Opiate Dependence HIV Infections | Behavioral: Integrating drug treatment into HIV services | Phase 4 |
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.
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | SPNS Buprenorphine and Integrated HIV Care Evaluation and Support Center: Integration of Buprenorphine and HIV Treatment Using the OASIS Model |
Study Start Date : | September 2005 |
Study Completion Date : | February 2009 |

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

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT00241930
Contact: Diana L Sylvestre, MD | 510-834-5442 | dsylves@itsa.ucsf.edu | |
Contact: Laphyne Barrett | 510-834-5442 | oasisclinic@sbcglobal.net |
United States, California | |
Alameda County Medical Center HIV Clinic | Recruiting |
Oakland, California, United States, 94602 | |
Contact: Lance Smith 510-437-4888 | |
Contact: Silver Sisneros, MD 510-437-4891 ssisneros@acmedctr.org | |
Principal Investigator: Silver Sisneros, DO | |
OASIS | Recruiting |
Oakland, California, United States, 94612 | |
Contact: Laphyne Barrett 510-834-5442 oasisclinic@sbcglobal.net | |
Principal Investigator: Diana L Sylvestre, MD | |
Fairmont Hospital HIV Clinic | Recruiting |
San Leandro, California, United States, 94578 | |
Contact: Lance Smith 510-437-4888 | |
Contact: Beth Schweitzer, MD 510-667-3201 | |
Principal Investigator: Beth Schweitzer, MD |
Principal Investigator: | Diana L Sylvestre, MD | Organization to Achieve Solutions in Substance Abuse (OASIS) | |
Study Director: | Ruth Finkelstein, ScD | New York Academy of Medicine |
ClinicalTrials.gov Identifier: | NCT00241930 History of Changes |
Other Study ID Numbers: |
H97HA03792 1 H97HA03792-01-00 |
First Posted: | October 19, 2005 Key Record Dates |
Last Update Posted: | October 25, 2005 |
Last Verified: | August 2005 |
Keywords provided by Organization to Achieve Solutions in Substance Abuse (OASIS):
Heroin HIV buprenorphine integration drug treatment |
Additional relevant MeSH terms:
HIV Infections Opioid-Related Disorders Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Substance-Related Disorders |
Chemically-Induced Disorders Mental Disorders Buprenorphine Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Narcotic Antagonists |