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Opioid Analgesic

Open Label Placebo for Acute Pain

N/A
Recruiting
Led By Michael H Bernstein, PhD
Research Sponsored by Brown University
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 7 days
Awards & highlights

Study Summary

This trial is testing whether being honest about taking a placebo pill can actually help relieve pain.

Who is the study for?
This trial is for English-speaking adults over 18 with acute pain from a fracture or hand/wrist surgery, who own a smartphone and plan to take prescribed opioids. It's not for those with chronic opioid use, psychotic disorders, medical marijuana prescriptions, worker's compensation claims, history of opioid disorder, or an allergy to opioids.Check my eligibility
What is being tested?
The study tests if taking openly labeled placebo pills alongside standard opioid medication can reduce pain and the amount of opioids taken by patients with acute pain. Participants will report their pain levels and opioid consumption daily via phone for one week.See study design
What are the potential side effects?
Since this trial involves placebos which are inactive substances along with standard care opioids, side effects may primarily stem from the opioid medications used and could include nausea, constipation, drowsiness or risk of dependency.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Prescription Opioid Use
Secondary outcome measures
Pain Intensity
Pain Interference

Trial Design

2Treatment groups
Experimental Treatment
Group I: Treatment as UsualExperimental Treatment1 Intervention
Opioid medication, as prescribed in routine care
Group II: Open Label Placebo + Treatment as UsualExperimental Treatment2 Interventions
Opioid medication, as prescribed in routine care + Honest placebos
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Open Placebo
2018
Completed Early Phase 1
~10

Find a Location

Who is running the clinical trial?

Rhode Island HospitalOTHER
260 Previous Clinical Trials
71,579 Total Patients Enrolled
1 Trials studying Acute Pain
20 Patients Enrolled for Acute Pain
Brown UniversityLead Sponsor
456 Previous Clinical Trials
562,926 Total Patients Enrolled
1 Trials studying Acute Pain
800 Patients Enrolled for Acute Pain
National Institute on Drug Abuse (NIDA)NIH
2,464 Previous Clinical Trials
2,618,438 Total Patients Enrolled
1 Trials studying Acute Pain
78 Patients Enrolled for Acute Pain

Media Library

Opioid medication as part of standard care (Opioid Analgesic) Clinical Trial Eligibility Overview. Trial Name: NCT05014230 — N/A
Acute Pain Research Study Groups: Treatment as Usual, Open Label Placebo + Treatment as Usual
Acute Pain Clinical Trial 2023: Opioid medication as part of standard care Highlights & Side Effects. Trial Name: NCT05014230 — N/A
Opioid medication as part of standard care (Opioid Analgesic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05014230 — N/A

Frequently Asked Questions

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

Are new participants being accepted for this clinical experiment?

"Affirmative, clinicaltrials.gov has details of this trial which is open for recruitment and was first published on December 9th 2021. As of February 9th 2022, 155 participants were needed from two sites for the study to go ahead."

Answered by AI

How many participants have become involved in this trial?

"Affirmative. According to the info hosted on clinicaltrials.gov, this research initiative is currently enrolling participants. The trial was published online in December 2021 and has most recently been amended in February 2022; 155 patients are required from 2 facilities."

Answered by AI

Who else is applying?

What state do they live in?
Arkansas
How old are they?
18 - 65
What site did they apply to?
The Miriam Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Open Label Placebo to Reduce Prescription Opioid Use
2021. "Open Label Placebo to Reduce Prescription Opioid Use". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05014230.
~46 spots leftby Apr 2025
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