Buprenorphine Implementation at Syringe Service Programs to Reduce Overdoses
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMontefiore Medical Center
About this trial
This study is testing whether offering buprenorphine treatment directly at syringe service programs (SSPs) helps more people start and stay in treatment for opioid use disorder (OUD) than referring them to community buprenorphine treatment providers. Buprenorphine is a medication that helps reduce opioid cravings and withdrawal symptoms.
The study compares two ways of connecting people to treatment:
Referral to a community treatment provider (usual care before the new program begins).
Onsite, low-threshold buprenorphine treatment at the SSP, which allows participants to start medication quickly and without having to establish care at another provider.
Participants will be adults who have opioid use disorder and are SSP clients. Each SSP will begin offering the new onsite buprenorphine program at different times during the study. Researchers will collect information before and after the new program begins to see how it affects treatment engagement and health outcomes.
The study will also examine how easy or difficult it is for SSPs to start and run the new program, how acceptable it is to staff and participants, and whether it is cost-effective.
The overall goal is to find better ways to expand access to life-saving opioid treatment in community-based settings.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
≥ 18 years old;
Meet DSM-5 criteria for moderate or severe OUD;
Interest in receiving buprenorphine treatment;
Speaks English or Spanish;
Disqualifiers
Current use of prescribed opioid agonist treatment, as assessed by self-report, at the time of enrollment;
Unstable mental health or medical condition that requires an immediate clinical evaluation or higher level of care;
Allergy to buprenorphine;
Currently detained in jail, prison, residential substance use treatment facility, or other overnight facility as required by court of law. or have pending legal action that could prevent participation on study activities.
Trial design
Design model
Sequential
Treatments tested in this trial
Standard of Care Referral
Other interventionDuring the pre-implementation phase, SSP staff will refer participants with opioid use disorder to external community providers for buprenorphine treatment. Services offered include information, referral assistance, and linkage to care, but buprenorphine will not be initiated or managed at the SSP site.
Low Threshold Buprenorphine
BehavioralDuring the post-implementation phase, SSPs will implement a low-threshold model of care for buprenorphine treatment. This model includes: Low barrier to entry Flexible scheduling and follow-up procedures Risk reduction counseling Collaboration with a peer outreach worker Training and technical assistance for SSP staff and clinicians to deliver care in non-traditional, low-barrier settings This intervention focuses on implementing and evaluating a service delivery model to expand access to medication for opioid use disorder within SSPs.
Treatment groups
512 Participants
are divided into 2 treatment groupsGroup A: Treatment As Usual (TAU)Active comparator 1 intervention
Group B: Low-threshold Buprenorphine (LTB)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
3-month Buprenorphine treatment retention (3-month retention)
Buprenorphine (BUP) treatment retention will be defined as having an active buprenorphine prescription between baseline and 1-month and between the 1-month (days 1-30) and 3-month (days 31-90) time points. Participants will be asked to provide evidence of BUP prescriptions at study visits (i.e., confirmed prescriptions). If a participant receives a second BUP prescription before the 1-month follow-up and the number of days dispensed covers dates after day 30 (i.e., carries over into the 31-90 days interval), this participant will have met the primary outcome. The primary outcome will require at least one day of an active BUP prescription based on confirmed prescriptions within the 2 time-points. BUP treatment retention will be summarized as a binary ("Yes/No") variable. The number/percentage of participants who are retained at each timepoint will be summarized by arm. BUP treatment retention is the primary measure of effectiveness.
Time frame
Between baseline and 1-month following intervention, and between baseline and 3-months following interventionSecondary outcomes
1
Buprenorphine Adherence
Adherence to buprenorphine is a composite measure and will be defined as participants meeting the primary outcome AND having a urine drug screen (UDS) that is positive for BUP at the 3-month timepoint. The number/percentage of participants who demonstrate BUP adherence will be summarized by arm.
Time frame
Baseline to 3-months following intervention2
6-month Buprenorphine Treatment Retention (6-month retention)
Buprenorphine (BUP) treatment retention at 6-months is a composite measure and will be defined as participants meeting the primary outcome AND having an active BUP prescription at the 1-month, 3-month, and 6-month timepoints.
Time frame
From baseline to 6-months following intervention3
Treatment and Recovery Activities
Treatment and Recovery activities will be measured using the Treatment Effectiveness Assessment (TEA). The TEA is a patient-centered instrument for evaluating progress in recovery from addiction. The TEA consists of 4 items used to measure recovery progress in substance use, health, lifestyle, and community domains. Participants rate progress on a scale from 1 ("not better") to 10 ("very much better"), yielding a total score from 4-40, wherein higher scores indicate greater improvement. Results will be summarized by study arm using descriptive statistics.
Time frame
6-months following intervention4
Non-prescribed Opioid Use
Non-prescribed opioid use will be determined by the number of self-reported days of use of heroin, fentanyl, methadone, or opioid analgesics in the prior 30 days at each study visit (1-month, 3-months, and 6-months). Results will be summarized by study arm.
Time frame
1-month, 3-months, and 6-months following interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Montefiore Medical Center
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
New York University
Collaborator
The Emmes Company, LLC
Collaborator
Source ClinicalTrials.gov