EMS-Initiated Buprenorphine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Opioid Use Disorder. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Emergency Medical Services (EMS)-Initiated Buprenorphine
Overview
This is a multisite EMS study that will first conduct a sequence of pragmatic, prehospital field studies to provide preliminary feasibility, acceptability, and safety data for refinement and enhancement of a subsequent single-arm prospective trial that will provide preliminary effectiveness data, from which to build a larger randomized control trail (RCT) trial.
Detailed description
Evaluating the EMS clinical protocol details and subsequent research procedures will be accomplished by enrolling approximately five EMS-initiated BUP encounters per site. Subsequently, a pragmatic field study will engage approximately thirty successful BUP initiations to assess the feasibility, acceptability, and safety of the EMS clinical protocol and follow up procedures. Investigators will also enroll a cohort of up to thirty patients per site who are eligible for BUP but refuse for informative purposes only, to understand reasons for refusal. Qualitative data on the refusal cohort will be analyzed separately. The outcomes of the pragmatic studies will inform revisions to the EMS clinical protocol.
A single-arm prospective trial of approximately 100 patients per site will subsequently be conducted to collect preliminary data on the effectiveness of EMS-initiated BUP on engagement in MOUD treatment within 10 and 30 days after the EMS-initiated BUP encounter.
Primary outcome measures
- Primary Outcome Measure for Pragmatic Field Study [Time frame: Baseline]
- Primary Outcome Measure for the Single Arm Prospective Trial [Time frame: Within 10 days after EMS encounter]
Secondary outcome measures (4)
- Engagement in Treatment (30) [Time frame: Within 30 days after EMS encounter]
- Precipitated Withdrawal [Time frame: Baseline]
- ED Visits and Hospitalizations [Time frame: Within 30 days after EMS encounter]
- Adverse Events [Time frame: Within 30 days after EMS-BUP encounter]
Eligibility criteria
Inclusion criteria
- 18 years of age or older
- Treated by the EMS-Initiated buprenorphine clinical protocol which includes:
Patients that accept EMS-Initiated BUP protocol. Patients offered the EMS-Initiated BUP protocol but declined.1
- Willing to follow study procedures.
- Able to speak English sufficiently to understand study procedures, and to provide verbal and electronic/written consent.
Exclusion criteria
- Patients who lack decision making capacity
- Patients who are in police or protective custody
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 3 centers
- Alameda Health System — Oakland
- Hennepin Healthcare — Minneapolis
- Cooper University Hospital — Camden
Identifiers
NCT: NCT07475728 · 2000041916 · 3UG1DA015831-24S1