Opioid-related DisordersNCT02583243
Project BEST: Buprenorphine Entry Into Substance Abuse Treatment
An observational study of Opioid-related Disorders and HIV Infections, run by Yale University at 1 site in United States.
Trial summary
Project BEST is a clinical project funded by the Substance Abuse and Mental Health Services Administration (SAMHSA) to increase treatment to opiate dependent patients with mental illness in New Haven, CT and to prospectively follow everyone enrolled in buprenorphine care for as long as the individual takes… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid-related Disorders, HIV Infections, Hepatitis C, Chronic
- What is being tested?
- MET/CBT based individualized counseling and Buprenorphine
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 209 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Aug 2008
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a prospective cohort of opioid dependent patients at risk for HIV or with HIV seeking treatment with buprenorphine. Subjects may have severe mental illness and other co-morbid medical conditions.
Who may be able to join
- Opiate dependent by DSM IV criteria - to be determined by clinician - on buprenorphine through the Project BEST Program.
Who cannot join
- Inability to adhere to study instruments.
Trial locations and contacts
1 site in 1 country.
About this study
Project BEST is a clinical project funded by the Substance Abuse and Mental Health Services Administration (SAMHSA) to increase treatment to opiate dependent patients with mental illness in New Haven, CT and to prospectively follow everyone enrolled in buprenorphine care for as long as the individual takes buprenorphine to track the success of buprenorphine for the maintenance of opiate dependence.
Read the detailed description
The investigators propose to create a prospective cohort that will track outcomes for an opiate dependent population on buprenorphine maintenance. Individuals who have already decided to undergo buprenorphine treatment in Project BEST will be invited to participate in the following data collection process. The investigators propose the following series of data collection to assess clients during their time in the cohort:
GPRA, supplemental instrument, ASI, SCID, COWS, Urine toxicology.
Patients who are enrolled will enter a standardized, manual based weekly counseling regimen. Urine toxicology will be performed a minimum of twice monthly, but will not occur at the same times monthly to decrease the probability of sampling error.
This is a prospective cohort to follow a group of individuals on buprenorphine treatment. The goal of this prospective cohort is to generate thoughtful observations. Specific items of interest which will be compared with age, race matched historical controls on methadone will be:
- Changes in addiction severity over treatment time
- Changes in sexual risk behaviors and injection practices
- Improvements in urine toxicology
- Co-occurring mental illness
- Being tested
- MET/CBT based individualized counseling, Buprenorphine
- Keywords
- Opioid dependence, HIV/AIDS, Hepatitis C, Severe mental illness, Injection Drug Use
- Medical subject headings
- Opioid-Related Disorders, HIV Infections, Hepatitis C, Chronic, Depression, Acquired Immunodeficiency Syndrome, Hepatitis C, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MET/CBT based individualized counselingBehavioural
Manualized counseling with the first four week being MET followed by 8 weeks of CBT
BuprenorphineDrug
Target dose in stabilization is 16 mg of buprenorphine to be taken sublingually once daily.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startMay 2005
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-related DisordersStudies of the same condition, open and under way.
- More trials run by Yale 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederick L Altice, MD, Principal investigator, Yale University AIDS Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583243
- Sponsor's protocol ID
- 0504027630_B
- Other IDs
- SAMHSA TCE/HIV 15767
- Status last verified
- Apr 2020
- First submitted
- 5 Jun 2008
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project BEST: Buprenorphine Entry Into Substance Abuse Treatment
- ClinicalTrials.gov ID
- NCT02583243
- Acronym / sponsor ID
- 0504027630_B
- Keywords
- Opioid dependence, HIV/AIDS, Hepatitis C, Severe mental illness, Injection Drug Use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 22 Oct 2015 (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.
Project BEST is a clinical project funded by the Substance Abuse and Mental Health Services Administration (SAMHSA) to increase treatment to opiate dependent patients with mental illness in New Haven, CT and to prospectively follow everyone enrolled in buprenorphine care for as long as the individual takes buprenorphine to track the success of buprenorphine for the maintenance of opiate dependence.
Detailed description
The investigators propose to create a prospective cohort that will track outcomes for an opiate dependent population on buprenorphine maintenance. Individuals who have already decided to undergo buprenorphine treatment in Project BEST will be invited to participate in the following data collection process. The investigators propose the following series of data collection to assess clients during their time in the cohort:
GPRA, supplemental instrument, ASI, SCID, COWS, Urine toxicology.
Patients who are enrolled will enter a standardized, manual based weekly counseling regimen. Urine toxicology will be performed a minimum of twice monthly, but will not occur at the same times monthly to decrease the probability of sampling error.
This is a prospective cohort to follow a group of individuals on buprenorphine treatment. The goal of this prospective cohort is to generate thoughtful observations. Specific items of interest which will be compared with age, race matched historical controls on methadone will be:
- Changes in addiction severity over treatment time
- Changes in sexual risk behaviors and injection practices
- Improvements in urine toxicology
- Co-occurring mental illness
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective cohort of opioid dependent patients at risk for HIV or with HIV seeking treatment with buprenorphine. Subjects may have severe mental illness and other co-morbid medical conditions.
Key inclusion criteria (1 listed)
- Opiate dependent by DSM IV criteria - to be determined by clinician - on buprenorphine through the Project BEST Program.
Key exclusion criteria (1 listed)
- Inability to adhere to study instruments.
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 |
|---|---|---|
| MET/CBT based individualized counselingManualized counseling with the first four week being MET followed by 8 weeks of CBT | Behavioural | – |
| BuprenorphineTarget dose in stabilization is 16 mg of buprenorphine to be taken sublingually once daily. | Drug | – |
Primary outcome
Not reported in the source record.
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 3 Apr 2020.
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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.
Frederick L Altice, MD principal investigator
Yale University AIDS Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid-related Disorders and HIV Infections, run by Yale 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 1 inclusion and 1 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 3 Apr 2020. 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.
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 3 Apr 2020.