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Opioid Analgesic

Buprenorphine for Pain

Phase 2
Waitlist Available
Research Sponsored by Alameda Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ED patients with acute pain NRS ≥7 warranting IV opioid analgesia (according to ED provider)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10, 20, 30, 40, 50, and 60 minutes
Awards & highlights

Study Summary

This study evaluates intravenous (IV) buprenorphine versus IV morphine for the management of severe, acute pain among emergency department (ED) patients. ED patients with severe pain will be randomized in equal proportion to receive IV buprenorphine or IV morphine.

Eligible Conditions
  • Pain

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10, 20, 30, 40, 50, and 60 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10, 20, 30, 40, 50, and 60 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain score difference at 60 minutes
Secondary outcome measures
Adverse events
Pain reduction
Pain score difference at 10 minutes
+7 more

Side effects data

From 2014 Phase 3 trial • 815 Patients • NCT01675167
17%
Nausea
8%
Constipation
7%
Vomiting
7%
Headache
5%
Dizziness
5%
Somnolence
1%
Drug withdrawal syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
OL Buprenorphine HCl Buccal Film
DB Buprenorphine HCl Buccal Film
DB Placebo Film

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BuprenorphineExperimental Treatment1 Intervention
Patients will receive IV buprenorphine 0.3mg diluted to a volume of 10mL with NS in a plastic syringe administered over 3-5 minutes. At 20 minutes, the patient will be asked "would you like more pain medication?" If he/she answers "yes", then he/she will receive a second dose of IV buprenorphine 0.3mg.
Group II: MorphineActive Control1 Intervention
Patients will receive IV morphine 0.1mg/kg (max dose 8mg) diluted to a volume of 10mL with NS in a plastic syringe administered over 3-5 minutes. At 20 minutes, the patient will be asked "would you like more pain medication?" If he/she answers "yes", then he/she will receive a second dose of IV morphine 0.1mg/kg (max dose 8mg).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Buprenorphine
FDA approved

Find a Location

Who is running the clinical trial?

Alameda Health SystemLead Sponsor
5 Previous Clinical Trials
2,844 Total Patients Enrolled
2 Trials studying Pain
94 Patients Enrolled for Pain

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Intravenous Buprenorphine Versus Morphine for Severe Pain in the Emergency Department
David Duong 2017. "Intravenous Buprenorphine Versus Morphine for Severe Pain in the Emergency Department". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03256487.
All > Probuphine
~16 spots leftby Apr 2025
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