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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
Est. primary completion date
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


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
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