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

August 15, 2005
April 28, 2009
November 2005
April 2009   (final data collection date for primary outcome measure)
Retention to substance abuse treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Retention to substance abuse treatment over 12 months follow-up
Complete list of historical versions of study NCT00130819 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Visit attendance with primary medical provider
  • Urine drug screen positivity for opioids and other drugs
  • Use of and adherence with HAART
  • HIV RNA changes
  • CD4 cell count changes
  • Self-reported HIV transmission risk behaviors
  • Costs and resource utilization
Not Provided
Not Provided
 
Comparison of HIV Clinic-Based Treatment With Buprenorphine Versus Referred Care in Heroin-Dependent Participants
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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Opiate Dependence
  • HIV Seropositivity
  • HIV Infections
  • Behavioral: Clinic-based substance abuse treatment with buprenorphine
    Subjects receive integrated opioid-dependence treatment with buprenorphine/naloxone at the HIV clinic
  • 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
  • Experimental: 1
    Subjects receive integrated opioid-dependence treatment with buprenorphine/naloxone at the HIV clinic
    Intervention: Behavioral: Clinic-based substance abuse treatment with buprenorphine
  • Active Comparator: 2
    Subjects receive case management and referral to an off-site opioid treatment program for their opioid dependence
    Intervention: Behavioral: Case management and referred substance abuse treatment
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
April 2009
April 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00130819
H97HA03794, HRSA-04-078
Not Provided
Gregory M. Lucas, MD PhD, Johns Hopkins University
Johns Hopkins University
The New York Academy of Medicine
Principal Investigator: Gregory M Lucas, MD, PhD Johns Hopkins University
Johns Hopkins University
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP