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Open Label Placebo to Reduce Prescription Opioid Use

Primary Purpose

Acute Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Open Placebo
Opioid medication as part of standard care
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Pain focused on measuring pain, placebo, analgesia, opioid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion

  • 18 years or older
  • English Speaking
  • Has a working smart-phone
  • Able to provide informed consent
  • Present for upper or lower extremity fracture (ED sample only) or for hand or wrist surgery (hand surgery sample only)
  • Are expected to be prescribed opioids at discharge
  • Are expected to be discharged from the Emergency Department (ED sample only)
  • Intends to take 1 or more doses of opioid medication as prescribed

Exclusion

  • Chronic opioid use
  • Unlikely to follow-up (discretion of investigator and treating provider)
  • Having been diagnosed with a psychotic disorder
  • Having a current medical marijuana prescription
  • Currently receiving worker's compensation or intending to apply for worker's compensation
  • History of opioid use disorder
  • Allergy to opioid medication

Sites / Locations

  • Lifespan Hospital SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Treatment as Usual

Open Label Placebo + Treatment as Usual

Arm Description

Opioid medication, as prescribed in routine care

Opioid medication, as prescribed in routine care + Honest placebos

Outcomes

Primary Outcome Measures

Prescription Opioid Use
Quantity of Opioid Use (converted to MME when possible)

Secondary Outcome Measures

Pain Intensity
Pain Intensity subscale of the Brief Pain Inventory
Pain Interference
Pain interference subscale of the Brief Pain Inventory

Full Information

First Posted
August 13, 2021
Last Updated
February 21, 2023
Sponsor
Brown University
Collaborators
National Institute on Drug Abuse (NIDA), The Miriam Hospital, Rhode Island Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05014230
Brief Title
Open Label Placebo to Reduce Prescription Opioid Use
Official Title
Acute Pain Treatment: A Randomized Controlled Trial Examining Opioids and Open Placebo
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 9, 2021 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brown University
Collaborators
National Institute on Drug Abuse (NIDA), The Miriam Hospital, Rhode Island Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of the proposed study is to examine the efficacy of using an honest placebo to relieve pain for patients with an acute pain condition. People with acute pain will receive their standard dose of opioid medication for pain management. In addition, some people will be asked to take placebo pills, honestly described as placebos, as well. Patients will answer a few short questions over the phone once per day for seven days about pain and opioid use. The investigators hypothesize that participants in the open label placebo group will take fewer opioids and have less pain than those in the treatment as usual group.
Detailed Description
America is in the midst of an opioid epidemic. One of the reasons opioid addiction and overdose deaths have recently increased is that doctors are frequently prescribing opioid medication as a treatment for pain. If researchers can develop ways of increasing the pain-relief patients experience from a set amount of opioids, then doctors might ultimately be able to prescribe fewer opioid medications, which could help curb the opioid crisis. Although "placebos," a medication whose benefit derives solely from positive psychological factors rather than pharmacological factors, are often disparaged in medicine, research suggests that placebos can actually help reduce pain. In fact, there is reason to think that placebos are effective even when a patient knows they are taking a placebo. The goal of the proposed study is to examine the efficacy of using an honest placebo to relieve pain for patients with an acute pain condition. People with acute pain in the Emergency Department, or patients undergoing hand/wrist surgery, will receive their standard dose of opioid medication for pain management. In addition, some people will be asked to take placebo pills, honestly described as placebos, as well. Patients will answer a few short questions over the phone once per day for seven days regarding their pain, opioid use, and placebo use (only those assigned to take placebo pills).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
Keywords
pain, placebo, analgesia, opioid

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
155 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment as Usual
Arm Type
Other
Arm Description
Opioid medication, as prescribed in routine care
Arm Title
Open Label Placebo + Treatment as Usual
Arm Type
Experimental
Arm Description
Opioid medication, as prescribed in routine care + Honest placebos
Intervention Type
Dietary Supplement
Intervention Name(s)
Open Placebo
Intervention Description
Zeebo
Intervention Type
Other
Intervention Name(s)
Opioid medication as part of standard care
Intervention Description
Opioid medication as prescribed by prescriber. This is not impacted by being in the research study.
Primary Outcome Measure Information:
Title
Prescription Opioid Use
Description
Quantity of Opioid Use (converted to MME when possible)
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Pain Intensity
Description
Pain Intensity subscale of the Brief Pain Inventory
Time Frame
7 days
Title
Pain Interference
Description
Pain interference subscale of the Brief Pain Inventory
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion 18 years or older English Speaking Has a working smart-phone Able to provide informed consent Present for upper or lower extremity fracture (ED sample only) or for hand or wrist surgery (hand surgery sample only) Are expected to be prescribed opioids at discharge Are expected to be discharged from the Emergency Department (ED sample only) Intends to take 1 or more doses of opioid medication as prescribed Exclusion Chronic opioid use Unlikely to follow-up (discretion of investigator and treating provider) Having been diagnosed with a psychotic disorder Having a current medical marijuana prescription Currently receiving worker's compensation or intending to apply for worker's compensation History of opioid use disorder Allergy to opioid medication
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael H Bernstein, PhD
Phone
401-863-7688
Email
michael_bernstein@brown.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Francesca Beaudoin, MD PhD
Phone
401-519-0330
Email
Francesca_Beaudoin@brown.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael H Bernstein, PhD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lifespan Hospital System
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesca Beaudoin, MD PhD
Phone
401-519-0330
Email
Francesca_Beaudoin@brown.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Open Label Placebo to Reduce Prescription Opioid Use

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