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ED Observation for Opioid Use Disorder
Phase < 1
Recruiting
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
Is 18 years of age or older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 90 visit
Awards & highlights
Study Summary
This trial is testing whether an extended ED visit is more effective than a standard ED visit for treating patients with untreated OUD.
Who is the study for?
This trial is for adults over 18 who visit the ED with untreated Opioid Use Disorder (OUD), can speak English, and are not currently in formal addiction treatment. They must be willing to receive standard or extended care based on random assignment and have a history of non-medical opioid use.Check my eligibility
What is being tested?
The study compares two approaches for managing patients with OUD in the emergency department: standard care versus an extended visit through observation. Participants will be randomly placed into one of these two groups at several New York hospitals.See study design
What are the potential side effects?
Since this trial involves observation rather than medication or medical procedures, there are no direct side effects from interventions being tested. However, participants may experience discomfort due to longer stays in the ED if assigned to extended observation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 90 visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 90 visit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants confirmed to be engaged in formal addiction treatment at 30 days
Proportion of participants confirmed to be successfully linked to formal addiction treatment within 1 week
Proportion of participants initiated on BUP in ED directly via administration or prescription
+1 moreSecondary outcome measures
Days of opioid and other drug use
Number of overdose events and risk behaviors
Proportion of participants who reported changes in social determinants of health
+7 moreSide effects data
From 2016 Phase 3 trial • 356 Patients • NCT0004899731%
Fatigue (lethargy, malaise, asthenia)
23%
Alopecia
17%
Late RT Toxicity: Other: NOS
11%
Nausea
10%
Anorexia
9%
Late RT Toxicity: Brain: NOS
9%
Headache
7%
Late RT Toxicity: Skin: NOS
6%
Memory loss
1%
Dyspnea (shortness of breath)
1%
Mood alteration-depression
1%
Hemorrhage-Other
1%
Ataxia (incoordination)
1%
Pain-Other
100%
80%
60%
40%
20%
0%
Study treatment Arm
Prophylactic Cranial Irradiation (PCI)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Extended visit with ObservationExperimental Treatment1 Intervention
Participants will have extended Emergency Department visit by having an observation (which could be up to 23 hours) time in addition to the standard ED visit. In addition, information will be gathered about about the participants, use of opioids, healthcare visits, the quality of health, life, and treatment, and other topics. Urine or saliva or both may also be collected.
Group II: Standard visitActive Control1 Intervention
Participants will have standard Emergency Department visit as per standard operating procedures which should last approximately 3 -5 hours.
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,368 Previous Clinical Trials
839,496 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,700 Previous Clinical Trials
7,506,646 Total Patients Enrolled
Ryan McCormack, MDPrincipal InvestigatorNYU Langone Health
2 Previous Clinical Trials
405 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am considered a candidate for starting medication treatment for opioid use in the emergency department.I am open to being randomly assigned to standard or enhanced emergency care.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Standard visit
- Group 2: Extended visit with Observation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this study open to octogenarians?
"Based on the age requirements set out by this clinical trial, anyone 18 or older can volunteer to participate. The oldest eligible patient is 100 years old."
Answered by AI
Where are the medical facilities that are running this clinical trial?
"This trial is currently being conducted at 5 different locations, which are listed as follows: NYULH-Brooklyn in Brooklyn, Northwell Health - Staten Island University Hospital in Staten Island, Bellevue in New york."
Answered by AI
Are people currently signing up for this clinical trial?
"The study is currently looking for 230 participants between 5 different centres, as of June 27th, 2022. This information can be found on clinicaltrials.gov, which also hosts the study's posting from April 21st, 2020."
Answered by AI
How can I sign up to be a part of this research project?
"Opioid addicts that falls between the ages of 18 and 100 may be accepted into this trial, with around 230 people being admitted in total."
Answered by AI
How many individuals are being monitored in this research project?
"We can verify that this is an ongoing trial by checking clinicaltrials.gov, which says the study was first posted on 4/21/2022 and updated as recently as 6/27/2022. They are looking for 230 patients total from 5 different locations."
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?
NYULH-Brooklyn
What portion of applicants met pre-screening criteria?
Met criteria
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