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Open Label Placebo to Reduce Prescription Opioid Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05014230
Recruitment Status : Recruiting
First Posted : August 20, 2021
Last Update Posted : February 10, 2022
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
The Miriam Hospital
Rhode Island Hospital
Information provided by (Responsible Party):
Brown University

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.

Condition or disease Intervention/treatment Phase
Acute Pain Dietary Supplement: Open Placebo Other: Opioid medication as part of standard care Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Prevention
Official Title: Acute Pain Treatment: A Randomized Controlled Trial Examining Opioids and Open Placebo
Actual Study Start Date : December 9, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Treatment as Usual
Opioid medication, as prescribed in routine care
Other: Opioid medication as part of standard care
Opioid medication as prescribed by prescriber. This is not impacted by being in the research study.

Experimental: Open Label Placebo + Treatment as Usual
Opioid medication, as prescribed in routine care + Honest placebos
Dietary Supplement: Open Placebo
Zeebo

Other: Opioid medication as part of standard care
Opioid medication as prescribed by prescriber. This is not impacted by being in the research study.




Primary Outcome Measures :
  1. Prescription Opioid Use [ Time Frame: 7 days ]
    Quantity of Opioid Use (converted to MME when possible)


Secondary Outcome Measures :
  1. Pain Intensity [ Time Frame: 7 days ]
    Pain Intensity subscale of the Brief Pain Inventory

  2. Pain Interference [ Time Frame: 7 days ]
    Pain interference subscale of the Brief Pain Inventory



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05014230


Contacts
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Contact: Michael H Bernstein, PhD 401-863-7688 michael_bernstein@brown.edu
Contact: Francesca Beaudoin, MD PhD 401-519-0330 Francesca_Beaudoin@brown.edu

Locations
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United States, Rhode Island
Lifespan Hospital System Recruiting
Providence, Rhode Island, United States, 02912
Contact: Francesca Beaudoin, MD PhD    401-519-0330    Francesca_Beaudoin@brown.edu   
Sponsors and Collaborators
Brown University
National Institute on Drug Abuse (NIDA)
The Miriam Hospital
Rhode Island Hospital
Investigators
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Principal Investigator: Michael H Bernstein, PhD Brown University
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Responsible Party: Brown University
ClinicalTrials.gov Identifier: NCT05014230    
Other Study ID Numbers: 2106003017
K01DA048087 ( U.S. NIH Grant/Contract )
First Posted: August 20, 2021    Key Record Dates
Last Update Posted: February 10, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brown University:
pain
placebo
analgesia
opioid
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents