NCT05014230

Open Label Placebo to Reduce Prescription Opioid Use

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 155 (estimated)
• Sponsor: Brown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Acute Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-12-09
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2021-08-20
• Last updated: 2023-02-22

Locations

1 site across 1 country: United States