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| ID | Type | Description | Link |
|---|---|---|---|
| K01DA048087 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| The Miriam Hospital | OTHER |
| Rhode Island Hospital | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment as Usual | Other | Opioid medication, as prescribed in routine care |
|
| Open Label Placebo + Treatment as Usual | Experimental | Opioid medication, as prescribed in routine care + Honest placebos |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open Placebo | Dietary Supplement | Zeebo |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Prescription Opioid Use | Quantity of Opioid Use (converted to MME when possible) | 7 days |
| 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 |
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Inclusion
Exclusion
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael H Bernstein, PhD | Contact | 401-863-7688 | michael_bernstein@brown.edu | |
| Francesca Beaudoin, MD PhD | Contact | 401-519-0330 | Francesca_Beaudoin@brown.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael H Bernstein, PhD | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lifespan Hospital System | Recruiting | Providence | Rhode Island | 02912 | United States |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| Opioid medication as part of standard care |
| Other |
Opioid medication as prescribed by prescriber. This is not impacted by being in the research study. |
|
| 7 days |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |