The purpose of this study is to assess the feasibility, cost and effectiveness of interventions designed to integrate buprenorphine treatment for opioid dependence into HIV primary care in ten HIV care centers in the U.S.

Condition	Intervention	Phase
Substance-Related Disorders Drug Addiction HIV AIDS	Drug: Buprenorphine  Behavior: Integrated HIV care & office-based opioid dependence tmt	Phase IV

Further Study Details: 

Primary Outcomes: Substance use outcomes at 1, 3 and 6 months measured by self-report.; Urine toxicology results at 1, 3, 6, and 12 months.; Retention in and adherence to HIV care at 1, 3, 6, and 12 months.
Secondary Outcomes: Quality of life at 1, 3, 6, 9, and 12 months.; HIV-related health outcomes at 1, 3, 6, 9, and 12 months.
Expected Total Enrollment:  1350

Programs that integrate medical care and drug treatment have shown great promise in improving health and substance use related outcomes. The overlap in the epidemics of HIV (with its complex medical needs) and drug abuse makes HIV-infected drug users a population likely to benefit from the integration of primary care and drug treatment. The Drug Addiction Treatment Act of 2000 and the approval of buprenorphine for the office-based treatment of opioid addiction provide a new opportunity to integrate addiction treatment and medical care for people with HIV. Research has demonstrated the effectiveness of buprenorphine in reducing illicit drug use among opioid dependent people. However, little is known about implementing such programs in HIV care settings, their cost, what effect they have on the health outcomes and substance use behavior of PLWH/A, or their broader impact on providers, institutions, and local systems.

Through this study, approximately 1,350 HIV-infected individuals who meet criteria for opioid dependence will be selected by eleven model demonstration projects located in ten HIV care centers across the U.S. Information on patients’ drug use, HIV health status, service utilization, quality of life, and satisfaction with services as well as information about providers’ practices and attitudes towards treating drug dependent patients will be collected through face-to-face interviews, audio computer-assisted self-interviewing, written surveys, and chart abstractions. These data will be used to help replicate effective programs that integrated HIV care and drug treatment and to improve the care of HIV-infected opioid dependent individuals.

Comparisons: All eleven programs will compare a group of patients who receive integrated buprenorphine treatment and HIV care to a group of patients who receive an alternate intervention. However, the program designs and comparison group interventions vary across the sites and are locally determined. Some sites will implement randomized control designs, while others will use observational methods.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• HIV-infected
• Clinical diagnoses of opioid dependence
• Fluent in English or Spanish
• 18 years or older

Exclusion Criteria:

• liver function tests (transaminase only) at five times or higher normal level;
• DSM-IV criteria for benzodiazepine abuse or dependence within the past 6 months;
• DSM-IV criteria for alcohol dependence within the past 6 months;
• actively suicidal;
• psychiatric impairment that impedes ability to consent (dementia, delusional, actively psychotic);
• methadone dose exceeding levels allowing for safe transition to buprenorphine;
• pregnant women and women actively trying to become pregnant;
• clinical judgment of local site principal investigator that patient is inappropriate

Please refer to this study by ClinicalTrials.gov identifier  NCT00124358

Ruth Finkelstein, ScD      212.822.7266    rfinkelstein@nyam.org
Julie C Netherland, MSW      212.419.3560    jnetherland@nyam.org

Arizona
      El Rio Santa Cruz Neighborhood Health Center, Tucson,  Arizona,  85745,  United States
California
      Organization to Achieve Solutions in Substance Abuse, Oakland,  California,  94612,  United States
      University of California San Francisco, San Francisco,  California,  94110,  United States
Connecticut
      Yale University School of Medicine AIDS Program, New Haven,  Connecticut,  06510,  United States
Florida
      University of Miami School of Medicine, Miami,  Florida,  33136,  United States
Illinois
      The CORE Center, Chicago,  Illinois,  60612,  United States
Maryland
      Johns Hopkins University, Baltimore,  Maryland,  21287,  United States
New York
      Montefiore Medical Center, New York,  New York,  10467,  United States
Oregon
      Oregon Health & Science University, Portland,  Oregon,  97239,  United States
Rhode Island
      The Miriam Hospital, Providence,  Rhode Island,  02903,  United States

Study chairs or principal investigators

Ruth Finkelstein, ScD,  Principal Investigator,  New York Academy of Medicine   
David Fiellin, MD,  Principal Investigator,  Yale University   

Study ID Numbers:  063005; H97HA03795
Last Updated:  August 1, 2005
Record first received:  July 26, 2005
ClinicalTrials.gov Identifier:  NCT00124358
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-02