Opioid Use Disorder
Conditions
Keywords
Emergency Medical Services, Buprenorphine, Substance use disorder treatment
Brief summary
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.
Interventions
None listed
Sponsors
Yale University
National Drug Abuse Treatment Clinical Trials Network
The Emmes Company, LLC
National Institute on Drug Abuse (NIDA)
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome Measure for Pragmatic Field Study | Baseline | Feasibility and acceptability will be measured by the proportion of patients who accept EMS-initiated BUP among all patients who are offered the EMS-initiated BUP clinical protocol. |
| Primary Outcome Measure for the Single Arm Prospective Trial | Within 10 days after EMS encounter | The proportion of participants engaged in MOUD within 10 days post EMS-initiated BUP among participants who received BUP and consented to be followed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Engagement in Treatment (30) | Within 30 days after EMS encounter | The proportion of patients participating in MOUD treatment |
| Precipitated Withdrawal | Baseline | The proportion of patients who develop precipitated withdrawal among all those who accepted EMS buprenorphine. |
| ED Visits and Hospitalizations | Within 30 days after EMS encounter | Proportion of patients with subsequent ED visits and hospitalizations post EMS BUP among those who accepted EMS buprenorphine |
| Adverse Events | Within 30 days after EMS-BUP encounter | The number of adverse events per participant after EMS-BUP initiation among all those who accepted EMS-BUP |
Countries
United States
Contacts
CONTACTGail D'Onofrio, MD, MS
CONTACTGerard Carroll, MD
PRINCIPAL_INVESTIGATORGail D'Onofrio, MD, MS
Yale University
Outcome results
None listed