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Opioid Partial Agonist

Onsite Buprenorphine Treatment for Opioid Addiction (O-BMT Trial)

Phase 2
Waitlist Available
Led By Aaron Fox, MD, MS
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

O-BMT Trial Summary

This trial will test whether starting buprenorphine treatment for opioid use disorder at a syringe exchange program is more effective than referral to a community health center.

Who is the study for?
This trial is for adults over 18 in New York City who use syringe exchange programs and want treatment for opioid addiction. They must be interested in buprenorphine therapy, not pregnant, without severe alcohol or benzodiazepine disorders, stable mental health, and not recently on opioid agonist treatment.Check my eligibility
What is being tested?
The study compares starting buprenorphine at a syringe exchange program versus getting referred to a community health center for the same treatment. It aims to see which method is more effective for people with opioid use disorder.See study design
What are the potential side effects?
Buprenorphine can cause side effects like dizziness, drowsiness, constipation, headache, nausea, sweating and might lead to dependency or withdrawal symptoms if stopped suddenly.

O-BMT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

O-BMT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Buprenorphine Engagement
Secondary outcome measures
Diversion
HIV risk behaviors
Incremental cost-effectiveness ratio (ICER)
+1 more

O-BMT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: O-BMT (onsite treatment)Experimental Treatment2 Interventions
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
Group II: Enhanced ReferralActive Control2 Interventions
In the control arm, participants will receive enhanced referral to a community health center for maintenance buprenorphine treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Onsite treatment
2019
Completed Phase 2
~100
Buprenorphine
2014
Completed Phase 4
~2600

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor
441 Previous Clinical Trials
582,098 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,465 Previous Clinical Trials
2,618,535 Total Patients Enrolled
5 Trials studying Opioid Addiction
648 Patients Enrolled for Opioid Addiction
Aaron Fox, MD, MSPrincipal InvestigatorAssociate Professor of Medicine

Media Library

Opioid Addiction Research Study Groups: O-BMT (onsite treatment), Enhanced Referral

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are participating in this experiment?

"Affirmative. Current information hosted on clinicaltrials.gov suggests that this medical trial, which was initially posted in the first of February 2019, is actively seeking patients to participate. A total of 250 individuals must be recruited from 3 various sites."

Answered by AI

Could you furnish information regarding prior experiments involving Buprenorphine?

"Buprenorphine is currently being assessed in 40 active trials, 11 of which are at the third stage. Durham, North carolina houses most of these investigations but they span a total number of 220 locations nationwide."

Answered by AI

Is this experiment currently accepting participants?

"Affirmative. According to clinicaltrials.gov, recruitment for this medical trial is currently underway with the initial posting on January 2nd 2019 and a recent update occurring September 30th 2022. A total of 250 individuals are required from 3 different locations."

Answered by AI

Has the Food and Drug Administration (FDA) accepted Buprenorphine as a viable treatment option?

"There is evidence to suggest that Buprenorphine has a degree of safety, leading our team at Power to rate it as a 2. Whilst there are data points supporting its security, no studies exist demonstrating the efficacy of this drug yet."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
New York Harm Reduction Educators
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Onsite Buprenorphine Treatment at Syringe Exchange Programs
Aaron D. Fox 2019. "Onsite Buprenorphine Treatment at Syringe Exchange Programs". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03150173.
All > Probuphine
~16 spots leftby Apr 2025
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