Integrating Buprenorphine Into HIV Treatment

HIV Infections Clinical Trial

Official title:

SPNS Buprenorphine and Integrated HIV Care Evaluation and Support Center: Integration of Buprenorphine and HIV Treatment Using the OASIS Model

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00241930
• Other study ID #: H97HA03792
• Secondary ID: 1 H97HA03792-01-
• Status: Recruiting
• Phase: Phase 4
• First received: October 17, 2005
• Last updated: October 24, 2005
• Start date: September 2005
• Est. completion date: February 2009

Study information

• Verified date: August 2005
• Source: Organization to Achieve Solutions in Substance Abuse (OASIS)
• Contact: Diana L Sylvestre, MD
• Phone: 510-834-5442
• Email: dsylves[@]itsa.ucsf.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Opiate Dependence

Intervention

Behavioral:
• Integrating drug treatment into HIV services

Locations

Country	Name	City	State
United States	Alameda County Medical Center HIV Clinic	Oakland	California
United States	OASIS	Oakland	California
United States	Fairmont Hospital HIV Clinic	San Leandro	California

Sponsors (1)

Lead Sponsor	Collaborator
Organization to Achieve Solutions in Substance Abuse (OASIS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1.Impact of integrated care vs nonintegrated care on:
Primary	a. Substance use and high-risk transmission behaviors
Primary	b. Medical engagement and outcomes
Primary	c. Psychosocial indices, such as criminal justice, employment, housing, and education
Secondary	1. Acceptability of HIV treatment-based buprenorphine therapy
Secondary	2. Health services utilization