MedDataX Logo

Integrating Buprenorphine Into HIV Treatment

NCT ID: NCT00241930

Last Updated: 2005-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2009-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Opiate Dependence HIV Infections

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Heroin HIV buprenorphine integration drug treatment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Integrating drug treatment into HIV services

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Organization to Achieve Solutions in Substance Abuse (OASIS)

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Diana L Sylvestre, MD

Role: PRINCIPAL_INVESTIGATOR

Organization to Achieve Solutions in Substance Abuse (OASIS)

Ruth Finkelstein, ScD

Role: STUDY_DIRECTOR

New York Academy of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Alameda County Medical Center HIV Clinic

Oakland, California, United States

Site Status RECRUITING

OASIS

Oakland, California, United States

Site Status RECRUITING

Fairmont Hospital HIV Clinic

San Leandro, California, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Diana L Sylvestre, MD

Role: CONTACT

Phone: 510-834-5442

Email: [email protected]

Laphyne Barrett

Role: CONTACT

Phone: 510-834-5442

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Lance Smith

Role: primary

Silver Sisneros, MD

Role: backup

Laphyne Barrett

Role: primary

Lance Smith

Role: primary

Beth Schweitzer, MD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1 H97HA03792-01-00

Identifier Type: -

Identifier Source: secondary_id

H97HA03792

Identifier Type: -

Identifier Source: org_study_id