Open Label Placebo to Reduce Prescription Opioid Use

Acute Pain Treatment: A Randomized Controlled Trial Examining Opioids and Open 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 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.

Study Overview

• Status: Recruiting
• Conditions: Acute Pain
• Intervention / Treatment: Other: Opioid medication as part of standard care; Dietary supplement: Open Placebo

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).

• Study Type: Interventional
• Enrollment (Anticipated): 155
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael H Bernstein, PhD; Phone Number: 401-863-7688; Email: michael_bernstein@brown.edu
• Study Contact Backup: Name: Francesca Beaudoin, MD PhD; Phone Number: 401-519-0330; Email: Francesca_Beaudoin@brown.edu

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02912
      • Recruiting
      • Lifespan Hospital System
      • Contact: Francesca Beaudoin, MD PhD; Phone Number: 401-519-0330; Email: Francesca_Beaudoin@brown.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Other: Opioid medication as part of standard care; Opioid medication as prescribed by prescriber. This is not impacted by being in the research study.; Dietary supplement: Open Placebo; Zeebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prescription Opioid Use	Quantity of Opioid Use (converted to MME when possible)	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	Pain Intensity subscale of the Brief Pain Inventory	7 days
Pain Interference	Pain interference subscale of the Brief Pain Inventory	7 days

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: National Institute on Drug Abuse (NIDA); The Miriam Hospital; Rhode Island Hospital
• Investigators: Principal Investigator: Michael H Bernstein, PhD, Brown University

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2021
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: August 13, 2021
• First Submitted That Met QC Criteria: August 13, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Estimate): February 22, 2023
• Last Update Submitted That Met QC Criteria: February 21, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: opioid; pain; placebo; analgesia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: 2106003017; K01DA048087 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No