Clinical trial NCT00241930: Integrating Buprenorphine Into HIV Treatment
Official title: SPNS Buprenorphine and Integrated HIV Care Evaluation and Support Center: Integration of Buprenorphine and HIV Treatment Using the OASIS Model
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Opiate Dependence
HIV Infections
Keywords: Heroin
HIV
buprenorphine
integration
drug treatment
Lead sponsor: Organization to Achieve Solutions in Substance Abuse (OASIS)
Sponsor class: OTHER
First posted: 2005-10-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: 1.Impact of integrated care vs nonintegrated care on:
measure: a. Substance use and high-risk transmission behaviors
measure: b. Medical engagement and outcomes
measure: c. Psychosocial indices, such as criminal justice, employment, housing, and education
Secondary outcomes:
measure: 1. Acceptability of HIV treatment-based buprenorphine therapy
measure: 2. Health services utilization
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Alameda County Medical Center HIV Clinic
state: California
city: Oakland
country: United States
facility: OASIS
state: California
city: San Leandro
country: United States
facility: Fairmont Hospital HIV Clinic
state: California
Study officials:
affiliation: Organization to Achieve Solutions in Substance Abuse (OASIS)
name: Diana L Sylvestre, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York Academy of Medicine
name: Ruth Finkelstein, ScD
role: STUDY_DIRECTOR
References: