Integrating Buprenorphine Into HIV Treatment
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
- 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
| 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:
- 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
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
No publications provided
| ClinicalTrials.gov Identifier: | NCT00241930 History of Changes |
| Other Study ID Numbers: | H97HA03792, 1 H97HA03792-01-00 |
| Study First Received: | October 17, 2005 |
| Last Updated: | October 24, 2005 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Organization to Achieve Solutions in Substance Abuse (OASIS):
|
Heroin HIV buprenorphine integration drug treatment |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome 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 Slow Virus Diseases Substance-Related Disorders |
Mental Disorders Buprenorphine Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotic Antagonists Narcotics |
ClinicalTrials.gov processed this record on May 19, 2013