Integrating Buprenorphine Into HIV Treatment

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified August 2005 by Organization to Achieve Solutions in Substance Abuse (OASIS).
Recruitment status was: Recruiting

Sponsor:

Information provided by:

Organization to Achieve Solutions in Substance Abuse (OASIS)

ClinicalTrials.gov Identifier:

NCT00241930

First received: October 17, 2005

Last updated: October 24, 2005

Last verified: August 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

October 17, 2005

Last Updated Date

October 24, 2005

Start Date ^ICMJE

September 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00241930 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Integrating Buprenorphine Into HIV Treatment

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Opiate Dependence
HIV Infections

Intervention ^ICMJE

Behavioral: Integrating drug treatment into HIV services

Study Arms

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Unknown status

Enrollment ^ICMJE

Estimated Completion Date

February 2009

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 85 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00241930

Other Study ID Numbers ^ICMJE

H97HA03792
1 H97HA03792-01-00

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Organization to Achieve Solutions in Substance Abuse (OASIS)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Diana L Sylvestre, MD	Organization to Achieve Solutions in Substance Abuse (OASIS)
Study Director:	Ruth Finkelstein, ScD	New York Academy of Medicine

PRS Account

Organization to Achieve Solutions in Substance Abuse (OASIS)

Verification Date

August 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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