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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00130819
• Other study ID #: H97HA03794
• Secondary ID: HRSA-04-078
• Status: Completed
• Phase: Phase 2
• First received: August 15, 2005
• Last updated: April 14, 2015
• Start date: November 2005
• Est. completion date: April 2009

Study information

• Verified date: April 2009
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• HIV Seropositivity
• Opiate Dependence
• Opioid-Related Disorders

Intervention

Behavioral:
• Clinic-based substance abuse treatment with buprenorphine
Subjects receive integrated opioid-dependence treatment with buprenorphine/naloxone at the HIV clinic
• Case management and referred substance abuse treatment
Subjects receive case management and referral to an off-site opioid treatment program for their opioid dependence

Locations

Country	Name	City	State
United States	Johns Hopkins HIV Clinic	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	The New York Academy of Medicine

Country where clinical trial is conducted

United States, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention to substance abuse treatment		12 months	No
Secondary	Visit attendance with primary medical provider		12 months	No
Secondary	Urine drug screen positivity for opioids and other drugs		12 months	No
Secondary	Use of and adherence to highly active antiretroviral therapy (HAART)		12 months	No
Secondary	HIV RNA changes		12 months	No
Secondary	CD4 cell count changes		12 months	No
Secondary	Self-reported HIV transmission risk behaviors		12 months	No
Secondary	Costs and resource utilization		12 months	No