Clinical trial NCT00798538: Integration of Buprenorphine Into HIV Clinical Settings - Primary Care Model (PCM)
Official title: Integration of Buprenorphine Into HIV Clinical Settings - Primary Care Model (PCM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Buprenorphine
HIV
Drug Abuse
Drug Addiction
Drug Dependence
Drug Use Disorders
Drug Use Disorder
Substance Abuse
Opiate Addiction
Substance-related Disorders
Keywords: Buprenorphine
HIV
Drug Abuse
Drug Addiction
Drug Dependence
Drug Use Disorders
Drug Use Disorder
Substance Abuse
Opiate Addiction
Substance-related disorders
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Waterbury Hospital
name: Health Resources and Services Administration (HRSA)
name: The New York Academy of Medicine
First posted: 2008-11-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

In the site led by Dr. Altice, we compare two models of providing HIV care and buprenorphine treatment. Assignments are based on participants' city of residence. In the onsite (integrated care) model, participants receive buprenorphine, substance abuse counseling and HIV care at one location: the Waterbury Hospital Infectious Disease Clinic. In the off-site model (non-integrated care) buprenorphine induction, substance abuse counseling, and HIV care will be provided at separate locations: the Community Health Care Van (CHCV), the Yale AIDS Program, and patients' own HIV providers, respectively. Data is collected from interviews with participants, reviews of medical records, and surveys and interviews with clinicians.


Eligibility criteria: 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

Primary outcomes:
measure: Substance use outcomes measured by self-report
timeFrame: at 1, 3, 6, 9 and 12 months measured by self-report
measure: Urine toxicology results
timeFrame: at 1, 3, 6, 9 and 12 months
measure: Retention in and adherence to HIV care
timeFrame: at 1, 3, 6, 9 and 12 months
Secondary outcomes:
measure: Quality of life
timeFrame: at 1, 3, 6, 9, and 12 months
measure: HIV-related health outcomes
timeFrame: at 1, 3, 6, 9, and 12 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale AIDS Program
state: Connecticut
Study officials:
affiliation: Yale University
name: Frederick Altice, MD
role: PRINCIPAL_INVESTIGATOR
References: