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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

No Placebo-Only Group

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.

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.

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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 90 visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Secondary study objectives

Days of opioid and other drug use

Score on EuroQol-5 Dimensions (EQ-5D) Scale

Score on EuroQol-5 Dimensions (EQ-5D) cale

+3 more

Side effects data

From 2016 Phase 3 trial • 356 Patients • NCT00048997

31%

Fatigue (lethargy, malaise, asthenia)

23%

Alopecia

17%

Late RT Toxicity: Other: NOS

11%

Nausea

10%

Anorexia

Late RT Toxicity: Brain: NOS

Headache

Late RT Toxicity: Skin: NOS

Memory loss

Dyspnea (shortness of breath)

Hemorrhage-Other

Ataxia (incoordination)

Mood alteration-depression

Pain-Other

100%

80%

60%

40%

20%

Study treatment Arm

Prophylactic Cranial Irradiation (PCI)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 1Eligibility criteria met