Opiate DependencePhase 2NCT00130819
Comparison of HIV Clinic-based Treatment With Buprenorphine Versus Referred Care in Heroin-dependent Participants
A Phase 2 study testing Clinic-based substance abuse treatment with buprenorphine and Case management and referred substance abuse treatment in people with Opiate Dependence and HIV Seropositivity, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opiate Dependence, HIV Seropositivity, HIV Infections
- What is being tested?
- Clinic-based substance abuse treatment with buprenorphine and Case management and referred substance abuse treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Apr 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed 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.
- Conditions
- Opiate Dependence, HIV Seropositivity, HIV Infections
- Being tested
- Clinic-based substance abuse treatment with buprenorphine, Case management and referred substance abuse treatment
- Keywords
- Drug Dependence, Opiate Dependence, Human Immunodeficiency Viruses, Buprenorphine
- Medical subject headings
- Opioid-Related Disorders, HIV Seropositivity, HIV Infections, Substance-Related Disorders, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinic-based substance abuse treatment with buprenorphineBehavioural
Subjects receive integrated opioid-dependence treatment with buprenorphine/naloxone at the HIV clinic
Case management and referred substance abuse treatmentBehavioural
Subjects receive case management and referral to an off-site opioid treatment program for their opioid dependence
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Subjects receive integrated opioid-dependence treatment with buprenorphine/naloxone at the HIV clinic Receives: 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 Receives: Behavioral: Case management and referred substance abuse treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention to substance abuse treatment
Measured: 12 months
Secondary outcomes (7)
Visit attendance with primary medical provider
Measured: 12 months
Urine drug screen positivity for opioids and other drugs
Measured: 12 months
Use of and adherence to highly active antiretroviral therapy (HAART)
Measured: 12 months
HIV RNA changes
Measured: 12 months
CD4 cell count changes
Measured: 12 months
Self-reported HIV transmission risk behaviors
Measured: 12 months
Costs and resource utilization
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2005 (estimated)
- Study startNov 2005
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opiate DependenceStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- The New York Academy of Medicine
- Investigators
- Gregory M Lucas, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00130819
- Sponsor's protocol ID
- H97HA03794
- Other IDs
- HRSA-04-078
- Status last verified
- Apr 2009
- First submitted
- 15 Aug 2005
- Last updated
- 15 Apr 2015
- Results posted
- No
Publications
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.
PubMed 20513828
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00130819
- Acronym / sponsor ID
- H97HA03794
- Conditions
- Opiate Dependence, HIV Seropositivity, HIV Infections
- Keywords
- Drug Dependence, Opiate Dependence, Human Immunodeficiency Viruses, Buprenorphine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- The New York Academy of Medicine
- Study start
- Nov 2005
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 16 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Clinic-based substance abuse treatment with buprenorphineSubjects receive integrated opioid-dependence treatment with buprenorphine/naloxone at the HIV clinic |
| 2 | Active comparator | Behavioral: Case management and referred substance abuse treatmentSubjects receive case management and referral to an off-site opioid treatment program for their opioid dependence |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinic-based substance abuse treatment with buprenorphineSubjects receive integrated opioid-dependence treatment with buprenorphine/naloxone at the HIV clinic | Behavioural | 1 |
| Case management and referred substance abuse treatmentSubjects receive case management and referral to an off-site opioid treatment program for their opioid dependence | Behavioural | 2 |
Primary outcome
Retention to substance abuse treatment
Time frame: 12 months
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
- Results publication: PubMed 20513828Lucas 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.
Related trials for Opiate Dependence
RecruitingPhase 2
Infusion of Lidocaine and Steroids in Middle Meningeal Artery for Pain in Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal, Headache
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
RecruitingPhase 2
A Study of Cebranopadol for Opioid Withdrawal Symptoms in Adults With Chronic Pain
Chronic Pain, Pain
Active, not recruiting
The MOUD Plus Pilot: Counseling and Peer Support to Support Retention for Medically Complex Patients With Opioid Use Disorder Seen In Primary Care
Opioid Dependence, Substance Abuse Disorders
RecruitingPhase 1
MethaLoad Dose-Finding Study
Opioid Use Disorder (OUD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory M Lucas, MD, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clinic-based substance abuse treatment with buprenorphine and Case management and referred substance abuse treatment in people with Opiate Dependence and HIV Seropositivity, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention to substance abuse treatment (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00130819, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2015.