Buprenorphine Naloxone for Opioid Use Disorder

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Opioid Use DisorderBuprenorphine Naloxone - Drug
Eligibility
18 - 80
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying a potential treatment for people who have opioid withdrawal or use disorder and come to the emergency department. The treatment is a loading dose of the drug buprenorphine, which could help link patients to outpatient treatment while minimizing known barriers to ED uptake.

Eligible Conditions
  • Opioid Use Disorder

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Research Visit 2 ( Day 1), Research Visit 3 (Day 2), Research Visit 4 (Day 3), Research phone call (Day 30)

Day 0
Proportion of participants with successful rapid induction
Day 3
Change in Opioid withdrawal and craving scores using SOWS during the index ED visit
Change in opioid withdrawal and craving using COWS
Day 30
Change in Time to next BUP dose (length of withdrawal suppression)
Change in healthcare utilization
Change in the Opioid and other illicit drug use

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

1 Treatment Group

BUP treatment arm
1 of 1

Experimental Treatment

35 Total Participants · 1 Treatment Group

Primary Treatment: Buprenorphine Naloxone · No Placebo Group · Phase 4

BUP treatment arm
Drug
Experimental Group · 1 Intervention: Buprenorphine Naloxone · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: research visit 2 ( day 1), research visit 3 (day 2), research visit 4 (day 3), research phone call (day 30)

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,263 Previous Clinical Trials
753,270 Total Patients Enrolled
Emergency Medicine FoundationOTHER
16 Previous Clinical Trials
2,329 Total Patients Enrolled
Ryan McCormack, MDPrincipal InvestigatorNYU Langone
2 Previous Clinical Trials
620 Total Patients Enrolled

Eligibility Criteria

Age 18 - 80 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The person has a positive urine test for opioids, meaning they have taken opioids, but the test for methadone is negative, meaning they have not taken methadone.
or computer The requester has reliable access to a phone or computer.
Is able to read, write, and understand English well enough to participate in the study.
This person meets the criteria for an opioid use disorder that is moderate to severe, as defined by the DSM-5.
The person is likely withdrawing from opioids and has a score of ≥8 on the COWS scale.
I am willing and able to participate in the study and follow study procedures.

Who else is applying?

What state do they live in?
New York100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
NYU Langone100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%