Integrating Buprenorphine Into HIV Treatment

Phase 4

• Conditions: Opiate Dependence; HIV Infections

• Registration Number: NCT00241930
• Lead Sponsor: Organization to Achieve Solutions in Substance Abuse (OASIS)

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.

Study Timeline

• Status Verified: 2005-08
• Study Start: 2005-09
• Study First Submitted: 2005-10-17
• Study First Submitted QC: 2005-10-17
• Study First Posted: 2005-10-19
• Last Update Submitted: 2005-10-24
• Last Update Posted: 2005-10-25
• Study Completion: 2009-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
1. Acceptability of HIV treatment-based buprenorphine therapy
2. Health services utilization

Trial Locations

Locations (3)

Alameda County Medical Center HIV Clinic; 🇺🇸 Oakland, California, United States

OASIS; 🇺🇸 Oakland, California, United States

Fairmont Hospital HIV Clinic; 🇺🇸 San Leandro, California, United States