Open Label Placebo to Reduce Prescription Opioid Use

Study Overview
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Brief Summary
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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
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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).

Official Title
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Acute Pain Treatment: A Randomized Controlled Trial Examining Opioids and Open Placebo

Conditions
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Acute Pain

Intervention / Treatment
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* Dietary Supplement: Open Placebo
* Other: Opioid medication as part of standard care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment as Usual<br>Opioid medication, as prescribed in routine care | Other: Opioid medication as part of standard care<br>* Opioid medication as prescribed by prescriber. This is not impacted by being in the research study.<br>|
| Experimental: Open Label Placebo + Treatment as Usual<br>Opioid medication, as prescribed in routine care + Honest placebos | Dietary Supplement: Open Placebo<br>* Zeebo<br>Other: Opioid medication as part of standard care<br>* Opioid medication as prescribed by prescriber. This is not impacted by being in the research study.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, placebo, analgesia, opioid