Integrating Buprenorphine Into HIV Treatment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by Organization to Achieve Solutions in Substance Abuse (OASIS).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Organization to Achieve Solutions in Substance Abuse (OASIS)
ClinicalTrials.gov Identifier:
NCT00241930
First received: October 17, 2005
Last updated: October 24, 2005
Last verified: August 2005
  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

Resource links provided by NLM:


Further study details as provided by Organization to Achieve Solutions in Substance Abuse (OASIS):

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

Estimated Enrollment: 60
Study Start Date: September 2005
Estimated Study Completion Date: February 2009
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241930

Contacts
Contact: Diana L Sylvestre, MD 510-834-5442 dsylves@itsa.ucsf.edu
Contact: Laphyne Barrett 510-834-5442 oasisclinic@sbcglobal.net

Locations
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         
Sponsors and Collaborators
Organization to Achieve Solutions in Substance Abuse (OASIS)
Investigators
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
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotic Antagonists

ClinicalTrials.gov processed this record on July 31, 2014