Opioid DependenceNCT01761110
Pilot Test of a Community-based Buprenorphine Treatment Intervention
A study testing Community-based buprenorphine treatment (CBBT) intervention in people with Opioid Dependence and Injection Drug Use, run by Albert Einstein College of Medicine at 1 site in United States.
Trial summary
The main goal of this study is to pilot test the community-based buprenorphine treatment (CBBT) intervention, examining buprenorphine treatment initiation, opioid use, and HIV risk behaviors. Two groups of participants will be followed for 60 days, with 3 research visits. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Dependence, Injection Drug Use
- What is being tested?
- Community-based buprenorphine treatment (CBBT) intervention
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Feb 2014
- 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
- at least 18 years old
- English or Spanish fluency
- ever injected drugs
- not receiving buprenorphine treatment (no prescribed buprenorphine in the previous 6 months)
- clients of our collaborating community-based organization
- interested in buprenorphine treatment
Who cannot join
- pregnant
- taking more than 60mg of methadone daily in the previous 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Heights Corner Project
New York, New York, 10033
About this study
Official title: Development of a Community-based Buprenorphine Treatment Intervention
The main goal of this study is to pilot test the community-based buprenorphine treatment (CBBT) intervention, examining buprenorphine treatment initiation, opioid use, and HIV risk behaviors. Two groups of participants will be followed for 60 days, with 3 research visits. One group will be enrolled prior to the CBBT intervention (pre-intervention), and one group after the CBBT intervention (post-intervention). Data sources will include questionnaires, urine toxicology tests, and medical record data. Investigators hypothesize that compared to the participants in the pre-intervention group, participants in the post-intervention group will be more likely to initiate buprenorphine treatment, reduce opioid use, and reduce high-risk HIV risk behaviors.
- Conditions
- Opioid Dependence, Injection Drug Use
- Being tested
- Community-based buprenorphine treatment (CBBT) intervention
- Keywords
- Opioid dependence, Injection drug use, Buprenorphine, Opioid agonist treatment, Access to care, HIV risk behaviors, Opioids
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-based buprenorphine treatment (CBBT) interventionBehavioural
Community-based buprenorphine treatment (CBBT) intervention consists of three components which are delivered to staff of syringe exchange programs, including: 1) providing buprenorphine education, 2) facilitating access to buprenorphine treatment, and 3) providing support to individuals who initiate buprenorphine treatment.
| Study group | Role | What they receive |
|---|---|---|
| Pre-intervention | No intervention | Participants will be enrolled prior to the implementation of the community-based buprenorphine treatment (CBBT) intervention. |
| Post-intervention | Experimental | Participants will be enrolled after implementing the community-based buprenorphine treatment (CBBT) intervention Receives: Behavioral: Community-based buprenorphine treatment (CBBT) intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
initiation of buprenorphine treatment
Medical record information will be extracted to determine initiation of buprenorphine treatment, which will be defined as a visit with a medical provider in which buprenorphine is prescribed.
Measured: 60 days
Secondary outcomes (1)
opioid use
Opioid use will be determined via self-report using the Addiction Severity Index and via urine specimens (e.g., urine toxicology testing).
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid DependenceStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), City University of New York, Washington Heights Corner Project
- Responsible party
- Principal investigator, Chinazo Cunningham, Albert Einstein College of Medicine
- Investigators
- Chinazo Cunningham, MD, MS, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01761110
- Sponsor's protocol ID
- 2012-381
- Other IDs
- R34DA031066
- Status last verified
- Apr 2018
- First submitted
- 2 Jan 2013
- Last updated
- 23 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Community-based Buprenorphine Treatment Intervention
- ClinicalTrials.gov ID
- NCT01761110
- Acronym / sponsor ID
- 2012-381
- Conditions
- Opioid Dependence, Injection Drug Use
- Keywords
- Opioid dependence, Injection drug use, Buprenorphine, Opioid agonist treatment, Access to care, HIV risk behaviors, Opioids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), City University of New York, Washington Heights Corner Project
- Study start
- Dec 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 4 Jan 2013 (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 main goal of this study is to pilot test the community-based buprenorphine treatment (CBBT) intervention, examining buprenorphine treatment initiation, opioid use, and HIV risk behaviors. Two groups of participants will be followed for 60 days, with 3 research visits. One group will be enrolled prior to the CBBT intervention (pre-intervention), and one group after the CBBT intervention (post-intervention). Data sources will include questionnaires, urine toxicology tests, and medical record data. Investigators hypothesize that compared to the participants in the pre-intervention group, participants in the post-intervention group will be more likely to initiate buprenorphine treatment, reduce opioid use, and reduce high-risk HIV risk behaviors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-intervention | No intervention | –Participants will be enrolled prior to the implementation of the community-based buprenorphine treatment (CBBT) intervention. |
| Post-intervention | Experimental | Behavioral: Community-based buprenorphine treatment (CBBT) interventionParticipants will be enrolled after implementing the community-based buprenorphine treatment (CBBT) intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- at least 18 years old
- English or Spanish fluency
- ever injected drugs
- not receiving buprenorphine treatment (no prescribed buprenorphine in the previous 6 months)
- clients of our collaborating community-based organization
Key exclusion criteria (2 listed)
- pregnant
- taking more than 60mg of methadone daily in the previous 30 days
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 |
|---|---|---|
| Community-based buprenorphine treatment (CBBT) interventionCommunity-based buprenorphine treatment (CBBT) intervention consists of three components which are delivered to staff of syringe exchange programs, including: 1) providing buprenorphine education, 2) facilitating access to buprenorphine treatment, and 3) providing support to individuals who initiate buprenorphine treatment. | Behavioural | Post-intervention |
Primary outcome
initiation of buprenorphine treatment
Time frame: 60 days
Medical record information will be extracted to determine initiation of buprenorphine treatment, which will be defined as a visit with a medical provider in which buprenorphine is prescribed.
1 secondary outcome
opioid use
Time frame: 60 days
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 23 Apr 2018.
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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.
Chinazo Cunningham, MD, MS principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community-based buprenorphine treatment (CBBT) intervention in people with Opioid Dependence and Injection Drug Use, run by Albert Einstein College of Medicine 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 6 inclusion and 2 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 23 Apr 2018. 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?
initiation of buprenorphine treatment (time frame: 60 days). 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 23 Apr 2018.