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| Sponsored by: |
Organization to Achieve Solutions in Substance Abuse (OASIS) |
|---|---|
| Information provided by: | Organization to Achieve Solutions in Substance Abuse (OASIS) |
| ClinicalTrials.gov Identifier: | NCT00241930 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Opiate Dependence HIV Infections |
Behavioral: Integrating drug treatment into HIV services |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | SPNS Buprenorphine and Integrated HIV Care Evaluation and Support Center: Integration of Buprenorphine and HIV Treatment Using the OASIS Model |
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | February 2009 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Diana L Sylvestre, MD | 510-834-5442 | dsylves@itsa.ucsf.edu |
| Contact: Laphyne Barrett | 510-834-5442 | oasisclinic@sbcglobal.net |
| United States, California | |
| OASIS | Recruiting |
| Oakland, California, United States, 94612 | |
| Contact: Laphyne Barrett 510-834-5442 oasisclinic@sbcglobal.net | |
| Principal Investigator: Diana L Sylvestre, MD | |
| 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 | |
| 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 |
More Information
| Study ID Numbers: | H97HA03792, 1 H97HA03792-01-00 |
| Study First Received: | October 17, 2005 |
| Last Updated: | October 24, 2005 |
| ClinicalTrials.gov Identifier: | NCT00241930 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Heroin HIV buprenorphine integration drug treatment |
|
Sexually Transmitted Diseases, Viral Heroin Narcotic Antagonists Acquired Immunodeficiency Syndrome Central Nervous System Depressants Disorders of Environmental Origin Narcotics Opioid-Related Disorders Immunologic Deficiency Syndromes Virus Diseases |
Buprenorphine HIV Infections Mental Disorders Sexually Transmitted Diseases Substance-Related Disorders Peripheral Nervous System Agents Analgesics Retroviridae Infections Analgesics, Opioid |
|
Sexually Transmitted Diseases, Viral Slow Virus Diseases Narcotic Antagonists Physiological Effects of Drugs Disorders of Environmental Origin Opioid-Related Disorders Infection Buprenorphine Mental Disorders Sensory System Agents Therapeutic Uses Substance-Related Disorders Analgesics Retroviridae Infections |
Analgesics, Opioid RNA Virus Infections Immune System Diseases Acquired Immunodeficiency Syndrome Central Nervous System Depressants Narcotics Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Peripheral Nervous System Agents Central Nervous System Agents |
