Open Label Placebo to Reduce Prescription Opioid Use

Not Applicable

Recruiting

• Conditions: Acute Pain
• Interventions: Dietary Supplement: Open Placebo; Other: Opioid medication as part of standard care

• Registration Number: NCT05014230
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2021-08-13
• Study First Submitted QC: 2021-08-13
• Study First Posted: 2021-08-20
• Study Start: 2021-12-09
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-21
• Last Update Posted: 2023-02-22
• Primary Completion: 2024-02-01
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 155

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open Label Placebo + Treatment as Usual	Open Placebo	Opioid medication, as prescribed in routine care + Honest placebos
Open Label Placebo + Treatment as Usual	Opioid medication as part of standard care	Opioid medication, as prescribed in routine care + Honest placebos
Treatment as Usual	Opioid medication as part of standard care	Opioid medication, as prescribed in routine care

Primary Outcome Measures

Name	Time	Method
Prescription Opioid Use	7 days	Quantity of Opioid Use (converted to MME when possible)

Secondary Outcome Measures

Name	Time	Method
Pain Interference	7 days	Pain interference subscale of the Brief Pain Inventory
Pain Intensity	7 days	Pain Intensity subscale of the Brief Pain Inventory

Trial Locations

Locations (1)

Lifespan Hospital System; 🇺🇸 Providence, Rhode Island, United States