Opiate AddictionPhase 2O-BMTNCT03150173
Onsite Buprenorphine Treatment at Syringe Exchange Programs
A Phase 2 study testing Onsite treatment, Enhanced referral and Buprenorphine in people with Opiate Addiction, run by Montefiore Medical Center at 3 sites in United States.
Trial summary
This trial will recruit syringe exchange participants with opioid use disorder in New York City and test whether starting buprenorphine treatment at the syringe exchange program is more effective than referral to a community health center for buprenorphine treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opiate Addiction
- What is being tested?
- Onsite treatment, Enhanced referral and Buprenorphine
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Jan 2019to 31 Mar 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- age ≥ 18 years
- opioid use disorder
- interest in buprenorphine treatment
- motivation for opioid use disorder treatment
- willingness to accept community health center referral
- syringe exchange participant
Who cannot join
- receiving opioid agonist treatment in the past 30 days (confirmed by New York Prescription Drug Monitoring Program);
- inability to provide informed consent
- unstable mental illness (e.g., suicidality, psychosis, etc.)
- severe alcohol use disorder or benzodiazepine use disorder by the Diagnostic and Statistical Manual of Mental disorders, Fifth Edition (DSM-5) criteria
- hypersensitivity to buprenorphine or naloxone.
- pregnancy (confirmed via urine testing)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Washington Heights CORNER Project
New York, New York, 10033
New York Harm Reduction Educators
New York, New York, 10035
BOOM!Health Harm Reduction Center
The Bronx, New York, 10451
About this study
Official title: Buprenorphine Treatment at Syringe Exchanges to Reduce Opioid Misuse and HIV Risk
This trial will recruit syringe exchange participants with opioid use disorder in New York City and test whether starting buprenorphine treatment at the syringe exchange program is more effective than referral to a community health center for buprenorphine treatment.
Read the detailed description
In a 24 week randomized controlled trial based in a large urban area with high rates of opioid use disorder (OUD) and HIV, 250 out-of-treatment opioid users who utilize syringe exchanges will be recruited and randomize to receive an onsite treatment intervention (O-BMT) or enhanced referral to buprenorphine treatment. Over 2 weeks, participants in the O-BMT arm will see a buprenorphine provider twice, receive weekly blister packs of medication, and then their care will be transferred to a community health center for maintenance buprenorphine treatment. In the control arm, participants will receive enhanced referral to the community health center for maintenance buprenorphine treatment. Data collection will include urine drug tests, questionnaires, and medical and pharmacy record review. Key outcomes will include engagement in buprenorphine treatment, treatment outcomes, and programmatic costs. Buprenorphine diversion will be assessed by using electronic monitors that estimate medication adherence, testing urine samples for buprenorphine, and through sequential surveys regarding buying or selling illicit buprenorphine.
- Conditions
- Opiate Addiction
- Being tested
- Onsite treatment, Enhanced referral, Buprenorphine
- Keywords
- opioid use disorder, syringe exchange, HIV risk reduction
- 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.
Onsite treatmentBehavioural
Participants will see a buprenorphine treatment provider who will assess for clinical criteria for opioid use disorder and write a prescription for buprenorphine treatment, which will be filled in a community pharmacy.
Enhanced referralBehavioural
Participants will receive an expedited appointment at a community health center for evaluation for buprenorphine treatment
BuprenorphineDrug
all participants will receive buprenorphine
| Study group | Role | What they receive |
|---|---|---|
| O-BMT (onsite treatment) | Experimental | Over 2 weeks at the syringe-exchange program, participants in the O-BMT arm will see a buprenorphine provider twice, receive weekly blister packs of medication, and then their care will be transferred to a community health center for maintenance buprenorphine treatment Receives: Behavioral: Onsite treatment; Drug: Buprenorphine |
| Enhanced Referral | Active comparator | In the control arm, participants will receive enhanced referral to a community health center for maintenance buprenorphine treatment Receives: Behavioral: Enhanced referral; Drug: Buprenorphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Buprenorphine Engagement
Buprenorphine engagement was defined as the number of participants having an active buprenorphine prescription at 30 days after randomization. Responses were tallied using a dichotomous (i.e., Yes/No) measure. Data are summarized by study arm.
Measured: 30 days after randomization
Secondary outcomes (9)
Treatment Retention
Treatment retention was assessed by the number/percentage of participants who had a medical visit AND active buprenorphine prescription each month after buprenorphine initiation for 6 months. Results are summarized by study arm.
Measured: 6 months
HIV Risk Behaviors
Change in HIV risk behaviors will be assessed using the HIV risk behavior survey. This survey, consisting of a dichotomous (yes/no) measure of injection risk, will be used based on self-report of at least one risk behavior (sharing syringes, not using bleach to clean syringes, sharing cookers, or front/back loading of syringes) reported during the interval. The number of participants demonstrating at least one risk behavior is during the 6 month interval is summarized by study arm.
Measured: 6 months
Buprenorphine Diversion
Buprenorphine diversion will be defined as having at least one problem behavior: non-adherence to prescribed medication on electronic monitoring, self-reported diversion, or a urine sample consistent with diversion during the 6 month interval. This outcome measure is used to determine how many participants sell or give away prescribed medication. The number of participants with at least one problem behavior is summarized by study arm.
Measured: 6 months
Incremental Cost-effectiveness Ratio (ICER)
The ICER will be calculated by dividing the incremental mean cost of the O-BMT arm relative to the control arm by the incremental mean effectiveness of the O-BMT arm relative to the control arm. The primary economic effectiveness outcome will be the quality-adjusted life-year (QALY), a measure that incorporates both duration and health-related quality-of-life and is recommended as the primary economic effectiveness measure. ICER is a composite measure that incorporates QALYs (also reported as a separate outcome measure) and mean costs (also reported as a separate outcome measure).
Measured: 6 months
Quality-adjusted Life-years (QALYs) Gained
The main economic effectiveness outcome will be the quality-adjusted life-year (QALY), a measure that incorporates both duration and health-related quality-of-life and is recommended as the primary economic effectiveness measure. Mean years gained are summarized by study arm.
Measured: 6 months
Mean Difference in Total Costs
Mean cost (in US dollars) of the O-BMT arm were compared to the control arm. The resource utilization and resulting cost of implementing and administering the O-BMT intervention were estimated using microcosting analysis and participant self-report. Mean costs (in US dollars) are summarized by study arm.
Measured: 6 months
Time to First Buprenorphine Prescription
Time to first buprenorphine prescription is defined as the amount of time, in days, from when a participant enrolled in the study to receipt of first buprenorphine prescription. Results are summarized by study arm using basic descriptive statistics.
Measured: 1 month
Number/Percentage of Participants Who Received Any Buprenorphine Prescription
The Number/percentage of participants who received any buprenorphine prescription is defined as the number/percentage of participants that filled at least one prescription for buprenorphine while enrolled in the study. Results are summarized by study arm.
Measured: 6 months
Total Time Prescribed Buprenorphine
Total time prescribed buprenorphine is defined as the amount of time in days that participants were prescribed buprenorphine during the study period. Results are summarized by study arm using basic descriptive statistics.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start2 Jan 2019
- Primary completion11 Oct 2023
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opiate AddictionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1 to receive the O-BMT intervention or enhanced referral
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Aaron Fox, MD, MS, Principal investigator, Associate Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03150173
- Sponsor's protocol ID
- 2017-7484
- Other IDs
- R01DA044878
- Acronym
- O-BMT
- Status last verified
- Nov 2025
- First submitted
- 9 May 2017
- Last updated
- 11 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Perez-Correa A, Abbas B, Riback L, Ghiroli M, Norton B, Murphy S, Jakubowski A, Hayes BT, Cunningham CO, Fox AD. Onsite buprenorphine inductions at harm reduction agencies to increase treatment engagement and reduce HIV risk: Design and rationale. Contemp Clin Trials. 2022 Mar;114:106674. doi: 10.1016/j.cct.2021.106674. Epub 2022 Jan 3.
PubMed 34990854
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buprenorphine Treatment at Syringe Exchanges to Reduce Opioid Misuse and HIV Risk
- ClinicalTrials.gov ID
- NCT03150173
- Acronym / sponsor ID
- O-BMT / 2017-7484
- Conditions
- Opiate Addiction
- Keywords
- opioid use disorder, syringe exchange, HIV risk reduction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 11 Oct 2023 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 12 May 2017 (actual)
- Results
- Posted 14 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will recruit syringe exchange participants with opioid use disorder in New York City and test whether starting buprenorphine treatment at the syringe exchange program is more effective than referral to a community health center for buprenorphine treatment.
Detailed description
In a 24 week randomized controlled trial based in a large urban area with high rates of opioid use disorder (OUD) and HIV, 250 out-of-treatment opioid users who utilize syringe exchanges will be recruited and randomize to receive an onsite treatment intervention (O-BMT) or enhanced referral to buprenorphine treatment. Over 2 weeks, participants in the O-BMT arm will see a buprenorphine provider twice, receive weekly blister packs of medication, and then their care will be transferred to a community health center for maintenance buprenorphine treatment. In the control arm, participants will receive enhanced referral to the community health center for maintenance buprenorphine treatment. Data collection will include urine drug tests, questionnaires, and medical and pharmacy record review. Key outcomes will include engagement in buprenorphine treatment, treatment outcomes, and programmatic costs. Buprenorphine diversion will be assessed by using electronic monitors that estimate medication adherence, testing urine samples for buprenorphine, and through sequential surveys regarding buying or selling illicit buprenorphine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 to receive the O-BMT intervention or enhanced referral
| Arm | Type | Receives |
|---|---|---|
| O-BMT (onsite treatment) | Experimental | Behavioral: Onsite treatment, Drug: BuprenorphineOver 2 weeks at the syringe-exchange program, participants in the O-BMT arm will see a buprenorphine provider twice, receive weekly blister packs of medication, and then their care will be transferred to a community health center for maintenance buprenorphine treatment |
| Enhanced Referral | Active comparator | Behavioral: Enhanced referral, Drug: BuprenorphineIn the control arm, participants will receive enhanced referral to a community health center for maintenance buprenorphine treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age ≥ 18 years
- opioid use disorder
- interest in buprenorphine treatment
- motivation for opioid use disorder treatment
- willingness to accept community health center referral
Key exclusion criteria (6 listed)
- receiving opioid agonist treatment in the past 30 days (confirmed by New York Prescription Drug Monitoring Program);
- inability to provide informed consent
- unstable mental illness (e.g., suicidality, psychosis, etc.)
- severe alcohol use disorder or benzodiazepine use disorder by the Diagnostic and Statistical Manual of Mental disorders, Fifth Edition (DSM-5) criteria
- hypersensitivity to buprenorphine or naloxone.
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 |
|---|---|---|
| Onsite treatmentParticipants will see a buprenorphine treatment provider who will assess for clinical criteria for opioid use disorder and write a prescription for buprenorphine treatment, which will be filled in a community pharmacy. | Behavioural | O-BMT (onsite treatment) |
| Enhanced referralParticipants will receive an expedited appointment at a community health center for evaluation for buprenorphine treatment | Behavioural | Enhanced Referral |
| Buprenorphineall participants will receive buprenorphine | Drug | Enhanced Referral, O-BMT (onsite treatment) |
Primary outcome
Buprenorphine Engagement
Time frame: 30 days after randomization
Buprenorphine engagement was defined as the number of participants having an active buprenorphine prescription at 30 days after randomization. Responses were tallied using a dichotomous (i.e., Yes/No) measure. Data are summarized by study arm.
9 secondary outcomes
Treatment Retention
Time frame: 6 months
HIV Risk Behaviors
Time frame: 6 months
Buprenorphine Diversion
Time frame: 6 months
Incremental Cost-effectiveness Ratio (ICER)
Time frame: 6 months
Quality-adjusted Life-years (QALYs) Gained
Time frame: 6 months
Mean Difference in Total Costs
Time frame: 6 months
Time to First Buprenorphine Prescription
Time frame: 1 month
Number/Percentage of Participants Who Received Any Buprenorphine Prescription
Time frame: 6 months
Total Time Prescribed Buprenorphine
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 34990854Perez-Correa A, Abbas B, Riback L, Ghiroli M, Norton B, Murphy S, Jakubowski A, Hayes BT, Cunningham CO, Fox AD. Onsite buprenorphine inductions at harm reduction agencies to increase treatment engagement and reduce HIV risk: Design and rationale. Contemp Clin Trials. 2022 Mar;114:106674. doi: 10.1016/j.cct.2021.106674. Epub 2022 Jan 3.
- Individual participant dataSharing planned: No
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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.
Aaron Fox, MD, MS principal investigator
Associate Professor of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Onsite treatment, Enhanced referral and Buprenorphine in people with Opiate Addiction, run by Montefiore Medical Center 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 6 inclusion and 6 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 11 Dec 2025. 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 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?
Yes. Results are posted in the registry (first posted 14 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Buprenorphine Engagement (time frame: 30 days after randomization). 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 NCT03150173, 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 11 Dec 2025.