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Opiate DependencePhase 4NCT00241930

Integrating Buprenorphine Into HIV Treatment

A Phase 4 study testing Integrating drug treatment into HIV services in people with Opiate Dependence and HIV Infections, run by Organization to Achieve Solutions in Substance Abuse (OASIS) at 3 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

We hypothesize that integrating drug treatment into HIV treatment will improve HIV outcomes as well as drug treatment outcomes in heroin users. This study will test this hypothesis by randomizing patients to two groups. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Opiate Dependence, HIV Infections
What is being tested?
Integrating drug treatment into HIV services
How many people
60 participants
Where
3 sitesUnited States
Study dates
Sep 2005to Feb 2009
Phase
Phase 4
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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • HIV+ as verified by lab report
  • DSM-IV diagnosis of opioid dependence
  • Speaks/understands English
  • Age 18 years or older

Who cannot join

  • LFT's (transaminase) >5x ULN
  • DSV-IV criteria for benzodiazepine abuse or dependence within the last month
  • DSM-IV criteria for alcohol dependence within the past 6 months
  • Actively suicidal
  • Methadone dose exceeds level allowing safe transition to buprenorphine
  • Pregnant women and women trying to become pregnant
  • Unable to provide informed consent
  • Clinical judgement that patient is inappropriate

Trial locations and contacts

3 sites in 1 country.

Diana L Sylvestre, MD contact

510-834-5442

dsylves@itsa.ucsf.edu

Laphyne Barrett contact

510-834-5442

oasisclinic@sbcglobal.net

United States3 sites, 3 recruiting

  • Alameda County Medical Center HIV Clinic

    Oakland, California, 94602

    Lance Smith, 510-437-4888

    Silver Sisneros, MD, 510-437-4891, ssisneros@acmedctr.org

    Recruiting

  • OASIS

    Oakland, California, 94612

    Laphyne Barrett, 510-834-5442, oasisclinic@sbcglobal.net

    Diana L Sylvestre, MD

    Recruiting

  • Fairmont Hospital HIV Clinic

    San Leandro, California, 94578

    Lance Smith, 510-437-4888

    Beth Schweitzer, MD, 510-667-3201

    Recruiting

Other trials in United States

About this study

Official title: SPNS Buprenorphine and Integrated HIV Care Evaluation and Support Center: Integration of Buprenorphine and HIV Treatment Using the OASIS Model

We hypothesize that integrating drug treatment into HIV treatment will improve HIV outcomes as well as drug treatment outcomes in heroin users. This study will test this hypothesis by randomizing patients to two groups. The first group will receive HIV treatment and buprenorphine treatment contemporaneously at their HIV clinic. The second group will receive HIV treatment at their HIV clinic, and go to another facility to receive buprenorphine treatment services.

We will look at HIV outcomes such as CD4 counts, HIV viral loads, and attendance at appointments and drug treatment outcomes such as receipt of buprenorphine and urine toxicology testing.

Read the detailed description

This study will test the hypothesis that integrating buprenorphine within the context of primary care HIV treatment will improve outcomes for HIV-infected heroin users vs providing buprenorphine services at a separate, off-site facility. As a means of engagement, we will offer the OASIS education group each week at each facility. For those randomized to integrated care, subjects will attend one education session weekly at the time of their HIV clinic. During these sessions, subjects will receive contemporaneous HIV clinic appointments (monthly), case management (monthly), drug counseling (twice monthly), and buprenorphine (which will be dispensed weekly.) For those randomized to separate care, subjects will attend HIV clinic appointments monthly, and will attend weekly education sessions at the OASIS facility. During these sessions, subjects will receive weekly buprenorphine, twice monthly drug counseling, and monthly case management.

We will measure outcomes by reporting attendance, CD4 counts, HIV viral loads, urine toxicology testing on at least a quarterly basis. We will also measure patient satisfaction, knowledge, quality of life, and a number of other outcomes.

Being tested
Integrating drug treatment into HIV services
Keywords
Heroin, HIV, buprenorphine, integration, drug treatment
Medical subject headings
Opioid-Related Disorders, HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Integrating drug treatment into HIV servicesBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1.Impact of integrated care vs nonintegrated care on:

  2. a. Substance use and high-risk transmission behaviors

  3. b. Medical engagement and outcomes

  4. c. Psychosocial indices, such as criminal justice, employment, housing, and education

Secondary outcomes (2)

  1. 1. Acceptability of HIV treatment-based buprenorphine therapy

  2. 2. Health services utilization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2005 (estimated)
  2. Study startSep 2005
  3. Study completionFeb 2009

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00241930
Sponsor's protocol ID
H97HA03792
Other IDs
1 H97HA03792-01-00
Status last verified
Aug 2005
First submitted
17 Oct 2005
Last updated
25 Oct 2005
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Integrating drug treatment into HIV services in people with Opiate Dependence and HIV Infections, run by Organization to Achieve Solutions in Substance Abuse (OASIS) at 3 sites 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 25 Oct 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Diana L Sylvestre, MD (510-834-5442, dsylves@itsa.ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1.Impact of integrated care vs nonintegrated care on:. The study lists 4 primary outcomes in all. 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 NCT00241930.

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 25 Oct 2005.

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