Buprenorphine for Opioid Use Disorder
(BISTRO Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether offering buprenorphine treatment directly at syringe service programs (SSPs) helps more people with opioid use disorder (OUD) start and stay in treatment compared to referrals to community providers. Buprenorphine reduces opioid cravings and withdrawal symptoms. Participants will either receive a referral to a community provider or have direct access to buprenorphine at the SSP. The study aims to evaluate how these approaches affect treatment engagement and health outcomes. It suits SSP clients with OUD who are interested in starting buprenorphine treatment. As an unphased trial, this study provides a unique opportunity for participants to contribute directly to innovative approaches in OUD treatment.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot be on prescribed opioid agonist treatment when you enroll.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that buprenorphine is generally safe when used as directed for treating opioid addiction. Studies have found that it reduces cravings and withdrawal symptoms, aiding individuals in continuing their treatment. Importantly, buprenorphine carries a lower risk of overdose compared to treatments like methadone. Additionally, no major side effects have been reported when used during pregnancy.
Overall, buprenorphine is well-tolerated. Its safety profile is similar to other treatments, and it can enhance the quality of life for those dealing with opioid addiction.12345Why are researchers excited about this trial?
Researchers are excited about the low-threshold buprenorphine (LTB) treatment for opioid use disorder because it offers easier access and fewer barriers than traditional options. Unlike standard care, which often requires referrals and appointments at external clinics, LTB is integrated directly into syringe service programs, allowing for on-site treatment. This approach minimizes obstacles, such as transportation and scheduling, and includes support from peer outreach workers to enhance treatment initiation and retention. This innovative model aims to engage more individuals in treatment by making it more convenient and accessible, potentially improving outcomes for those struggling with opioid addiction.
What evidence suggests that this trial's treatments could be effective for opioid use disorder?
Research has shown that buprenorphine effectively treats opioid addiction. It reduces cravings and withdrawal symptoms, helping individuals remain in treatment longer. Studies also indicate that buprenorphine use can lower the risk of overdose and decrease illegal opioid use. In this trial, participants will join different treatment arms. The Low-threshold Buprenorphine (LTB) arm aims to minimize barriers to treatment initiation and retention, enabling quick medication access and continued care. Overall, buprenorphine is a proven and safe option for managing opioid addiction.678910
Who Is on the Research Team?
Aaron D Fox, MD, MS
Principal Investigator
Albert Einstein College of Medicine
Are You a Good Fit for This Trial?
This trial is for adults (18+) who have moderate or severe opioid use disorder, are interested in buprenorphine treatment, speak English or Spanish, and are current clients at a syringe service program. Participants must be able to give informed consent.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-implementation (Treatment-as-Usual)
SSPs provide standard care, including referral to community MOUD providers for BUP treatment.
Post-implementation (Low-Threshold BUP Program)
SSPs offer onsite BUP treatment through trained prescribers and peer outreach workers.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Buprenorphine
Trial Overview
The study compares two ways of starting buprenorphine treatment: direct onsite access at syringe service programs versus referral to outside community providers. It aims to see which approach helps more people begin and stay in treatment.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
After implementation at each SSP site, participants will have access to on-site, low-threshold buprenorphine treatment integrated into SSP services. This model focuses on minimizing barriers to treatment initiation and retention and includes , flexible policies and procedures and collaboration with a peer outreach worker.
Participants enrolled before the intervention is implemented at each syringe service program (SSP) will receive standard of care, consisting of referral to community-based buprenorphine treatment providers. SSP staff will offer information and referral support but will not provide on-site buprenorphine treatment or prescribing.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Montefiore Medical Center
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
New York University
Collaborator
The Emmes Company, LLC
Industry Sponsor
Peter Ronco
The Emmes Company, LLC
Chief Executive Officer since 2023
BSc from Nottingham University
Dr. Joe Sliman
The Emmes Company, LLC
Chief Medical Officer since 2020
MD from Uniformed Services University of the Health Sciences, MPH from Johns Hopkins University, BSc in Molecular and Cell Biology from Pennsylvania State University
Citations
National Helpline for Mental Health, Drug, Alcohol Issues
SAMHSA's National Helpline is a free, confidential, 24/7, 365-day-a-year treatment referral and information service (in English and Spanish) ...
Defining low-threshold buprenorphine treatment - PMC - NIH
Buprenorphine treatment for opioid use disorder is safe and effective, but only a fraction of Americans who need treatment receive it.
3.
ldi.upenn.edu
ldi.upenn.edu/our-work/research-updates/lowering-the-barriers-to-medication-treatment-for-people-with-opioid-use-disorder/Issue Brief: Lowering the Barriers to Medication Treatment
Download Brief PDF Overdose deaths have reached unprecedented levels in the U.S., despite effective medications to treat opioid use ...
4.
integrationacademy.ahrq.gov
integrationacademy.ahrq.gov/products/topic-briefs/oud-low-threshold-treatmentThe Role of Low-Threshold Treatment for Patients with ...
Low-threshold treatment emphasizes medication for opioid use disorder (MOUD) through the removal of barriers, which allows profound healing to happen in the ...
Policies Should Promote Access to Buprenorphine for ...
FDA-approved medications—specifically, buprenorphine and methadone—have been shown to reduce the risk of overdose, illicit opioid use, and the ...
Buprenorphine Treatment for Opioid Use Disorder: An Overview
Among all randomized patients, buprenorphine was modestly superior to XR-naltrexone on the primary outcome of relapse, and on the number of opioid positive ...
History of the discovery, development, and FDA-approval ...
The primary endpoint was the percentage of urine samples negative for illicit opioids for weeks 1 to 16 and weeks 17 to 24. Participants who received active ...
What is Buprenorphine? Side Effects, Treatment & Use
When taken as prescribed, buprenorphine is safe and effective. Increase safety in cases of overdose. To begin treatment, an OUD patient must ...
Buprenorphine versus Methadone for Opioid Use Disorder ...
Buprenorphine may be associated with more favorable neonatal and maternal outcomes than methadone, but existing data are limited.
Buprenorphine - StatPearls - NCBI Bookshelf
The drug proves to be an effective choice for addressing opioid dependence by diminishing cravings and enhancing the overall quality of life during addiction ...
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