Comparison of HIV Clinic-Based Treatment With Buprenorphine Versus Referred Care in Heroin-Dependent Participants

This study has been completed.
Sponsor:
Collaborator:
The New York Academy of Medicine
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00130819
First received: August 15, 2005
Last updated: April 28, 2009
Last verified: April 2009
  Purpose

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.

Condition Intervention Phase
Opiate Dependence
HIV Seropositivity
HIV Infections
Behavioral: Clinic-based substance abuse treatment with buprenorphine
Behavioral: Case management and referred substance abuse treatment
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Retention to substance abuse treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visit attendance with primary medical provider [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Urine drug screen positivity for opioids and other drugs [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Use of and adherence to highly active antiretroviral therapy (HAART) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • HIV RNA changes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • CD4 cell count changes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Self-reported HIV transmission risk behaviors [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Costs and resource utilization [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: November 2005
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130819

Locations
United States, Maryland
Johns Hopkins HIV Clinic
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
The New York Academy of Medicine
Investigators
Principal Investigator: Gregory M Lucas, MD, PhD Johns Hopkins University
  More Information

Additional Information:
No publications provided by Johns Hopkins University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gregory M. Lucas, MD PhD, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00130819     History of Changes
Other Study ID Numbers: H97HA03794, HRSA-04-078
Study First Received: August 15, 2005
Last Updated: April 28, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Drug Dependence
Opiate Dependence
Human Immunodeficiency Viruses
Buprenorphine

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
HIV Seropositivity
Opioid-Related Disorders
Chemically-Induced Disorders
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Mental Disorders
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Substance-Related Disorders
Virus Diseases
Buprenorphine
Naloxone
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014