The purpose of this study to 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 :

1. 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).
2. Clinic-based treatment – participants receive counseling and treatment with buprenorphine at the HIV clinic.

Condition	Intervention	Phase
Opiate Dependence HIV Seropositivity	Behavior: Clinic-based substance abuse treatment with buprenorphine  Behavior: Case management and referred substance abuse treatment	Phase II

Further Study Details: 

Primary Outcomes: Retention to substance abuse treatment over 12 months follow-up
Secondary Outcomes: 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
Expected Total Enrollment:  120

We propose to enroll and randomize 120 opioid-dependent, HIV-infected participants, who receive care in the Johns Hopkins HIV Clinic to either 1) clinic-based care with buprenorphine (clinic-based BPN/NX arm) or 2) case management and referral to a 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:

1. Retention to substance abuse treatment,
2. Urine drug screens,
3. Adherence with HIV primary care provider visits
4. Use of and adherence to highly active antiretroviral therapy (HAART),
5. HIV RNA levels and CD4 cell counts,
6. HIV transmission risk behaviors (e.g., injection, sharing of drug paraphernalia, sexual behaviors),
7. Costs and resource utilization.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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 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 benzodiazepines 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00130819

Gregory M. Lucas, MD, PhD      410-614-0560    glucas@jhmi.edu

Maryland
      Johns Hopkins HIV Clinic, Baltimore,  Maryland,  21287,  United States

Study chairs or principal investigators

Gregory M Lucas, MD, PhD,  Principal Investigator,  Johns Hopkins University   

Study ID Numbers:  H97HA03794; HRSA-04-078
Last Updated:  August 15, 2005
Record first received:  August 15, 2005
ClinicalTrials.gov Identifier:  NCT00130819
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-23