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Opioid Partial Agonist

Buprenorphine Naloxone for Opioid Use Disorder

Phase 4
Waitlist Available
Led By Ryan McCormack, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (24 hours)
Awards & highlights

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (24 hours)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (24 hours) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Successful Rapid Induction
Secondary outcome measures
Number of Participants With Withdrawal Suppresion at Day 1 (24 Hours)
Number of Participants With Withdrawal Suppresion by Day 2
Number of Participants With Withdrawal Suppression on Day 3
+1 more

Side effects data

From 2023 Phase 4 trial • 15 Patients • NCT04283500
7%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
BUP Treatment Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: BUP treatment armExperimental Treatment1 Intervention
Subjects will be given BUP 32mg in 2 doses, and observed for at least 90 minutes after the 2nd dose. The whole process will take a total of about 3-4 hours including the consenting process. Subjects will be asked questions and be examined repeatedly. Subjects will have 4 in-person visits and a phone call in addition to review of medical records.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Buprenorphine Naloxone
2018
Completed Phase 4
~60

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,370 Previous Clinical Trials
840,789 Total Patients Enrolled
Emergency Medicine FoundationOTHER
17 Previous Clinical Trials
2,370 Total Patients Enrolled
Ryan McCormack, MDPrincipal InvestigatorNYU Langone
2 Previous Clinical Trials
620 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age criterion of this medical trial permit individuals younger than 45 to participate?

"This medical trial is accepting participants aged 18 and over, but no older than 80."

Answered by AI

What is the aggregate count of participants enrolled in this experiment?

"Precisely. The clinical trial's posting on clinicaltrials.gov reveals that it is presently looking for volunteers to take part in the study, which was originally published on November 1st 2020 and updated most recently on August 8th 2022. 35 participants are sought from one medical centre."

Answered by AI

Has the Food and Drug Administration sanctioned Buprenorphine Naloxone as a legitimate pharmaceutical?

"With Phase 4 approval, our team at Power confidently rate the safety of Buprenorphine Naloxone with a score of 3."

Answered by AI

In what scenarios is Buprenorphine Naloxone routinely administered?

"Buprenorphine Naloxone is a commonly used medication for treating opioid addiction. This substance has also been clinically proven to help patients with pruritus, pain, and septic shock manage their symptoms."

Answered by AI

Am I eligible to join this scientific investigation?

"This clinical trial is seeking 35 participants aged 18 to 80 who have opioid addiction. The key prerequisites for inclusion are: having reliable phone access, displaying visible signs of opiate withdrawal (as indicated by a COWS score of 8 or higher), adherence to the study's protocol and procedures, as well as providing accurate contact information for follow-up."

Answered by AI

Are there any vacancies left for participants in this research?

"Affirmative. The clinical trial registry indicates that recruitment is still ongoing for this investigation, which was posted on November 1st 2020 and last updated on August 8th 2022. 35 volunteers are sought from a single site to participate in the research."

Answered by AI

Could you elucidate on past research efforts related to Buprenorphine Naloxone?

"Currently, there are 55 clinical trials in progress researching Buprenorphine Naloxone's efficacy with 13 at the third phase. A majority of these studies is taking place in White River Junction, Vermont; however, 234 sites across the United States have been commissioned to conduct this research."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
NYU Langone
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Buprenorphine Loading in the Emergency Department
2020. "Buprenorphine Loading in the Emergency Department". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04283500.
~3 spots leftby May 2025
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