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

Sponsors and Collaborators:	Johns Hopkins University The New York Academy of Medicine
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00130819

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 II

MedlinePlus related topics: AIDS

Drug Information available for: Naloxone Naloxone hydrochloride Buprenorphine Buprenorphine hydrochloride Diacetylmorphine Diacetylmorphine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
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

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
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Active Comparator 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

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

Coordinating site webpage This link exits the ClinicalTrials.gov site

Responsible Party:	Johns Hopkins University ( Gregory M. Lucas, MD PhD )
Study ID Numbers:	H97HA03794, HRSA-04-078
Study First Received:	August 15, 2005
Last Updated:	September 30, 2008
ClinicalTrials.gov Identifier:	NCT00130819
Health Authority:	United States: Institutional Review Board

Keywords provided by Johns Hopkins University:

Drug Dependence
Opiate Dependence
Human Immunodeficiency Viruses
Buprenorphine

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral
Heroin
Acquired Immunodeficiency Syndrome
Disorders of Environmental Origin
Opioid-Related Disorders
Immunologic Deficiency Syndromes
Naloxone
Virus Diseases

Buprenorphine
HIV Seropositivity
HIV Infections
Mental Disorders
Sexually Transmitted Diseases
Substance-Related Disorders
Retroviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Infection

Pharmacologic Actions
Sensory System Agents
Therapeutic Uses
Lentivirus Infections
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 16, 2009