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

NCT00130819 | Completed Phase 2

• 2 other identifiers: H97HA03794HRSA-04-078
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opiate Dependence; HIV Seropositivity; HIV Infections

Keywords

Drug Dependence; Opiate Dependence; Human Immunodeficiency Viruses; Buprenorphine

Outcome Measures

Primary Outcomes (1)

• Retention to substance abuse treatment

  12 months

Secondary Outcomes (7)

• Visit attendance with primary medical provider

  12 months

• Urine drug screen positivity for opioids and other drugs

  12 months

• Use of and adherence to highly active antiretroviral therapy (HAART)

  12 months

• HIV RNA changes

  12 months

• CD4 cell count changes

  12 months

Study Arms (2)

1

EXPERIMENTAL

Subjects receive integrated opioid-dependence treatment with buprenorphine/naloxone at the HIV clinic

Behavioral: Clinic-based substance abuse treatment with buprenorphine

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

Interventions

Clinic-based substance abuse treatment with buprenorphine BEHAVIORAL

Subjects receive integrated opioid-dependence treatment with buprenorphine/naloxone at the HIV clinic

1

Case management and referred substance abuse treatment BEHAVIORAL

Subjects receive case management and referral to an off-site opioid treatment program for their opioid dependence

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-infected and receiving continuity care in the Johns Hopkins HIV Clinic
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• The New York Academy of Medicine: collaborator

Study Sites (1)

Johns Hopkins HIV Clinic

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• Lucas GM, Chaudhry A, Hsu J, Woodson T, Lau B, Olsen Y, Keruly JC, Fiellin DA, Finkelstein R, Barditch-Crovo P, Cook K, Moore RD. Clinic-based treatment of opioid-dependent HIV-infected patients versus referral to an opioid treatment program: A randomized trial. Ann Intern Med. 2010 Jun 1;152(11):704-11. doi: 10.7326/0003-4819-152-11-201006010-00003.

  PMID: 20513828 RESULT

Related Links

• Coordinating site webpage

MeSH Terms

Conditions

Opioid-Related Disorders; HIV Seropositivity; HIV Infections; Substance-Related Disorders; Acquired Immunodeficiency Syndrome

Interventions

Buprenorphine; Case Management

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Gregory M Lucas, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 15, 2005
• First Posted: August 16, 2005
• Study Start: November 1, 2005
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: April 15, 2015

Record last verified: 2009-04

Locations

US (1)