EMS-Initiated Buprenorphine
Purpose
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.
Condition
- Opioid Use Disorder
Eligibility
- Eligible Ages
- All ages
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Participants | Individuals with opioid use disorder (OUD) who encounter Emergency Medical Services (EMS) in the prehospital setting under one of two circumstances: (1) They have experienced an overdose requiring naloxone reversal or (2) They are in acute opioid abstinence withdrawal and are offered an EMS-initiated BUP clinical protocol. |
Recruiting Locations
Oakland, California 94602
Minneapolis, Minnesota 55415
Camden, New Jersey 08103
More Details
- Status
- Recruiting
- Sponsor
- Yale University
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.