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Study Profile:
Integrating Buprenorphine Opiod Treatment with HIV Primary Care (The ORACLE Study)

Revised:

December 5, 2006

Study Site:

The Miriam Hospital, Providence RI

Study Name:

Integrating Buprenorphine Opiod Treatment with HIV Primary Care (The ORACLE Study)

Study Status:

Enrolling Subjects

Principal Investigator:

Timothy P. Flanigan, MD

Years of Funding:

Study start: August 2005; Expected completion: August 2009

Study Design: Treatment, Non-Randomized, Parallel Assignment

Study Aims:

  1. Increase awareness, education, and referral among patients and clinicians regarding opioid addiction in an HIV primary care setting
  2. Integrate onsite treatment of opioid abuse using buprenorphine with HIV primary care
  3. Improve health outcomes through increased social stabilization among HIV-infected individuals receiving buprenorphine in an HIV primary care setting
  4. Evaluate and disseminate process and outcome data of the integrated buprenorphine/HIV primary care intervention, including associated costs.

Study or Clinic Location

Ester Chester Immunology Center, The Miriam Hospital

# of Participants:

Goal:

100 treatment, 100 comparison

Enrolled:

22 treatment, 8 comparison

Inclusion Criteria:

HIV-infected, Clinical diagnosis of opioid dependence, Fluent in English or Spanish, 18 years or older

Exclusion Criteria:

Liver function tests (transaminase only) at five times or higher than normal level;

Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (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

 

Definition of Drug Use:

Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) criteria; Clinical diagnosis of opioid dependence

Participant Characteristics:

% Female

35%

% HIV+

100%

% DU (IDU or non-IDU)

100% DU, 36% IDU, 64% non-IDU

Study Domains:

  • substance use
  • adherence to substance use treatment
  • barriers and facilitators to adherence with substance use treatment plan
  • HIV sexual and drug using risk behaviors
  • HIV-related medical care
  • adherence to other medications
  • depression
  • quality of life
  • health literacy

Data collection instruments:

  • Standardized assessment tools that have been validated, including the Multidimensional Quality of Life Questionnaire for Persons with HIV/AIDS
  • Test of Functional Health Literacy in Adults (TOFHLA)
  • Center for Epidemiologic Studies Depression Scale (CESD), will be incorporated into our assessment, as appropriate.
  • In addition, we will complete medical chart reviews and clinic records to collect information on CD4 and HIV RNA plasma viral load, frequency and compliance with clinic visits, and toxicology screens for participants on buprenorphine.

 

 

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