Comparison of HIV Clinic-based Treatment With Buprenorphine Versus Referred Care in Heroin-dependent Participants
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ClinicalTrials.gov Identifier: NCT00130819 |
Recruitment Status
:
Completed
First Posted
: August 16, 2005
Last Update Posted
: April 15, 2015
|
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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 or disease | Intervention/treatment | 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 |
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 (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | November 2005 |
Actual Primary Completion Date : | April 2009 |
Actual Study Completion Date : | April 2009 |

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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00130819
United States, Maryland | |
Johns Hopkins HIV Clinic | |
Baltimore, Maryland, United States, 21287 |
Principal Investigator: | Gregory M Lucas, MD, PhD | Johns Hopkins University |
Publications of Results:
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 |
First Posted: | August 16, 2005 Key Record Dates |
Last Update Posted: | April 15, 2015 |
Last Verified: | April 2009 |
Keywords provided by Johns Hopkins University:
Drug Dependence Opiate Dependence Human Immunodeficiency Viruses Buprenorphine |
Additional relevant MeSH terms:
HIV Infections Opioid-Related Disorders HIV Seropositivity Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Substance-Related Disorders Chemically-Induced Disorders |
Mental Disorders Analgesics, Opioid Buprenorphine Buprenorphine, Naloxone Drug Combination Naloxone Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Narcotic Antagonists |