HIV InfectionNCT00348868
Buprenorphine HIV Care Integration Project
A study testing enhanced behavioral motivation counseling, Motivational counseling and Standard counseling in people with HIV Infection and Opioid-Related Disorders, run by University of Miami at 1 site in United States.
Trial summary
A007 is a randomized, two-arm study evaluating the effectiveness of standard drug addiction counseling with buprenorphine/naloxone to enhanced motivational drug counseling with buprenorphine/naloxone for the treatment for opioid addiction in an integrated and nonintegrated HIV care setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection, Opioid-Related Disorders
- What is being tested?
- enhanced behavioral motivation counseling, Motivational counseling and Standard counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Dec 2007
- Phase
- Interventional
- 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 infection
- Receiving or seeking outpatient HIV care
- Seeking outpatient treatment for opioid dependence and be willing to take buprenorphine
- Meets DSM-IV criteria for opioid dependence, and be willing to stop illicit opioid use and be experiencing early symptoms of opioid withdrawal at the time that buprenorphine is given
- Men and women age ≥ 18 years
- Women of reproductive potential must have a negative serum or urine pregnancy test result available within 7 days prior to initiating buprenorphine
- Within 30 days: (SGOT), ALT (SGPT), and alkaline phosphatase <=5 X ULN, Total bilirubin <= 2.5 x ULN
Who cannot join
- Serious medical problem
- Acute and/or severe psychiatric conditions
- High dose methadone (>30 mg/day)
- Documented co-dependence on alcohol and/or benzodiazepines, barbiturates
- Chronic pain management requiring opioids
- Pregnancy or breast-feeding
- Imprisonment or involuntary incarceration in a medical facility for psychiatric or physical
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami AIDS Clinical Reserach Unit
Miami, Florida, 33136
About this study
Official title: Miami Buprenorphine HIV Care Integration Project
A007 is a randomized, two-arm study evaluating the effectiveness of standard drug addiction counseling with buprenorphine/naloxone to enhanced motivational drug counseling with buprenorphine/naloxone for the treatment for opioid addiction in an integrated and nonintegrated HIV care setting.
Read the detailed description
DESIGN: A007 is a randomized, two-arm study evaluating the effectiveness of standard drug addiction counseling with buprenorphine/naloxone to enhanced motivational drug counseling with buprenorphine/naloxone for the treatment for opioid addiction in an integrated and nonintegrated HIV care setting.
DURATION: Subjects will participate in this study for approximately 48 weeks. Chart abstractions will continue for up to four years.
SAMPLE SIZE: This study will enroll 60 subjects (30 per arm) over 72 weeks.
POPULATION: HIV-1 infected opioid dependent men and women ≥18 years of age who initiate buprenorphine for the treatment of opioid dependence and who are receiving primary care for HIV-1 infection.
STRATIFICATION: Subjects will be stratified at screening based on HIV care setting (integrated HIV care vs. nonintegrated HIV care)
INTERVENTON At entry subjects will be randomized to one of the following:
ARM A: Standard drug addiction counseling + buprenorphine / naloxone
ARM B: Enhanced behavioral motivation counseling + buprenorphine / naloxone
The three primary outcomes are:
- Cessation of illicit opioid use
- Reduction in high risk behavior
- Improved HIV therapy adherence
- Conditions
- HIV Infection, Opioid-Related Disorders
- Being tested
- enhanced behavioral motivation counseling, Motivational counseling, Standard counseling
- Keywords
- HIV Infection, Opioid dependence, DSM-IV criteria for opioid dependence
- Medical subject headings
- HIV Infections, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enhanced behavioral motivation counselingBehavioural
Motivational counselingBehavioural
Standard counselingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | enhanced behavioral motivation counseling Receives: Behavioral: enhanced behavioral motivation counseling; Behavioral: Motivational counseling |
| 2 | Active comparator | Not described Receives: Behavioral: Standard counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
The three primary outcomes are Cessation of illicit opioid use, Reduction in high risk behavior and Improved HIV therapy adherence
Measured: week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- HRSA/Maternal and Child Health Bureau, National Institute on Drug Abuse (NIDA)
- Investigators
- Margaret Fischl, M.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00348868
- Sponsor's protocol ID
- A007
- Status last verified
- Apr 2007
- First submitted
- 5 Jul 2006
- Last updated
- 18 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Miami Buprenorphine HIV Care Integration Project
- ClinicalTrials.gov ID
- NCT00348868
- Acronym / sponsor ID
- A007
- Conditions
- HIV Infection, Opioid-Related Disorders
- Keywords
- HIV Infection, Opioid dependence, DSM-IV criteria for opioid dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- HRSA/Maternal and Child Health Bureau, National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 6 Jul 2006 (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.
A007 is a randomized, two-arm study evaluating the effectiveness of standard drug addiction counseling with buprenorphine/naloxone to enhanced motivational drug counseling with buprenorphine/naloxone for the treatment for opioid addiction in an integrated and nonintegrated HIV care setting.
Detailed description
DESIGN: A007 is a randomized, two-arm study evaluating the effectiveness of standard drug addiction counseling with buprenorphine/naloxone to enhanced motivational drug counseling with buprenorphine/naloxone for the treatment for opioid addiction in an integrated and nonintegrated HIV care setting.
DURATION: Subjects will participate in this study for approximately 48 weeks. Chart abstractions will continue for up to four years.
SAMPLE SIZE: This study will enroll 60 subjects (30 per arm) over 72 weeks.
POPULATION: HIV-1 infected opioid dependent men and women ≥18 years of age who initiate buprenorphine for the treatment of opioid dependence and who are receiving primary care for HIV-1 infection.
STRATIFICATION: Subjects will be stratified at screening based on HIV care setting (integrated HIV care vs. nonintegrated HIV care)
INTERVENTON At entry subjects will be randomized to one of the following:
ARM A: Standard drug addiction counseling + buprenorphine / naloxone
ARM B: Enhanced behavioral motivation counseling + buprenorphine / naloxone
The three primary outcomes are:
- Cessation of illicit opioid use
- Reduction in high risk behavior
- Improved HIV therapy adherence
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: enhanced behavioral motivation counseling, Behavioral: Motivational counselingenhanced behavioral motivation counseling |
| 2 | Active comparator | Behavioral: Standard counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- HIV infection
- Receiving or seeking outpatient HIV care
- Seeking outpatient treatment for opioid dependence and be willing to take buprenorphine
- Meets DSM-IV criteria for opioid dependence, and be willing to stop illicit opioid use and be experiencing early symptoms of opioid withdrawal at the time that buprenorphine is given
- Men and women age ≥ 18 years
Key exclusion criteria (7 listed)
- Serious medical problem
- Acute and/or severe psychiatric conditions
- High dose methadone (>30 mg/day)
- Documented co-dependence on alcohol and/or benzodiazepines, barbiturates
- Chronic pain management requiring opioids
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 |
|---|---|---|
| enhanced behavioral motivation counseling | Behavioural | 1 |
| Motivational counseling | Behavioural | 1 |
| Standard counseling | Behavioural | 2 |
Primary outcome
The three primary outcomes are Cessation of illicit opioid use, Reduction in high risk behavior and Improved HIV therapy adherence
Time frame: week 48
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 18 Mar 2008.
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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.
Margaret Fischl, M.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enhanced behavioral motivation counseling, Motivational counseling and Standard counseling in people with HIV Infection and Opioid-Related Disorders, run by University of Miami 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 7 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 18 Mar 2008. 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.
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?
The three primary outcomes are Cessation of illicit opioid use, Reduction in high risk behavior and Improved HIV therapy adherence (time frame: week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2008.