Comparison of HIV Clinic-based Treatment With Buprenorphine Versus Referred Care in Heroin-dependent Participants

April 14, 2015 updated by: Johns Hopkins University

Buprenorphine Effectiveness Evaluation in HIV Enhancement (BEEHIVE): A Randomized Trial of HIV Clinic-based Buprenorphine/Naloxone vs. Case Management and Referral in Opioid-dependent Individuals

The purpose of this study is to compare the effectiveness of two approaches to treating HIV-infected patients who are addicted to opioid drugs (e.g., heroin) in an inner-city HIV clinic. The two approaches are:

  • Case management and referral - participants are managed by a case manager and referred to a specialized drug treatment center where they receive counseling and medications for opioid-dependence (e.g., methadone or buprenorphine); or
  • Clinic-based treatment - participants receive counseling and treatment with buprenorphine at the HIV clinic.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We, the investigators at Johns Hopkins University, propose to enroll and randomize 120 opioid-dependent, HIV-infected participants, who receive care in the Johns Hopkins HIV Clinic to either:

  • clinic-based care with buprenorphine (clinic-based BPN/NX arm); or
  • case management and referral to an opioid treatment program for opioid agonist-based therapy (case management and referral arm).

The study interventions and follow-up will last 12 months. Participants will be enrolled over a 3-year period. Participants who are assigned to the clinic-based BPN/NX arm will receive BPN/NX (Suboxone®), individual counseling from a nurse interventionist, and group therapy sessions. Participants who are assigned to the case management and referral arm will be enrolled in an established case management and adherence program in the Johns Hopkins HIV Clinic (Project LINK). LINK provides intensive case management, education, and support by a team that includes a social worker, a nurse, a pharmacist educator, and peer advocates. In addition to providing counseling and linkage to needed services, LINK will expedite intake at licensed opioid treatment programs that provide agonist-based therapy for opioid dependence. The clinic-based BPN intervention is a new strategy that was developed in a pilot project over the past 6 months. The case-management and referral arm represents standard-of-care in our clinic, which has been enhanced and codified for this trial. Study outcome visits will be performed at baseline, 1 month, 3 months, 6 months, 9 months, and 12 months.

Comparisons:

  • Retention to substance abuse treatment;
  • Urine drug screens;
  • Adherence to HIV primary care provider visits;
  • Use of and adherence to highly active antiretroviral therapy (HAART);
  • HIV RNA levels and CD4 cell counts;
  • HIV transmission risk behaviors (e.g., injection, sharing of drug paraphernalia, sexual behaviors);
  • Costs and resource utilization.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins HIV Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HIV-infected and receiving continuity care in the Johns Hopkins HIV Clinic
  • 18 years of age or older
  • Meets DSM-IV criteria for opioid dependence
  • Seeks agonist-based treatment for opioid dependence
  • Willing and able to provide written informed consent
  • Willing to be contacted by mail and telephone for study follow-up visit reminders
  • Willing to authorize release of information for substance abuse treatment to the study for a period of 12 months
  • If female, negative urine pregnancy test and willingness to practice birth control while on study if sexually active (barrier method or progesterone-containing contraception product)
  • Verbal approval from participant's primary HIV clinician

Exclusion Criteria:

  • Currently receiving methadone, naloxone, buprenorphine, or levomethadyl acetate (LAAM) as part of a licensed opioid treatment program
  • History of allergic reaction to buprenorphine or naloxone
  • Active medical need for opioid-based pain control
  • Active benzodiazepine abuse or dependence
  • Active alcohol dependence
  • Alanine aminotransferase level that is more than 5 times the upper limit of normal
  • Other condition that, in the opinion of the principal investigator, makes participation in the study unsafe or follow-up highly unlikely

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Subjects receive integrated opioid-dependence treatment with buprenorphine/naloxone at the HIV clinic
Behavioral: Clinic-based substance abuse treatment with buprenorphine
Subjects receive integrated opioid-dependence treatment with buprenorphine/naloxone at the HIV clinic
Active Comparator: 2
Subjects receive case management and referral to an off-site opioid treatment program for their opioid dependence
Behavioral: Case management and referred substance abuse treatment
Subjects receive case management and referral to an off-site opioid treatment program for their opioid dependence

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Retention to substance abuse treatment
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Self-reported HIV transmission risk behaviors
Time Frame: 12 months
12 months
Visit attendance with primary medical provider
Time Frame: 12 months
12 months
Urine drug screen positivity for opioids and other drugs
Time Frame: 12 months
12 months
Use of and adherence to highly active antiretroviral therapy (HAART)
Time Frame: 12 months
12 months
HIV RNA changes
Time Frame: 12 months
12 months
CD4 cell count changes
Time Frame: 12 months
12 months
Costs and resource utilization
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

The New York Academy of Medicine

Investigators

  • Principal Investigator: Gregory M Lucas, MD, PhD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

August 15, 2005

First Submitted That Met QC Criteria

August 15, 2005

First Posted (Estimate)

August 16, 2005

Study Record Updates

Last Update Posted (Estimate)

April 15, 2015

Last Update Submitted That Met QC Criteria

April 14, 2015

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H97HA03794
  • HRSA-04-078

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Clinic-based substance abuse treatment with buprenorphine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe