Open Label Placebo to Reduce Prescription Opioid Use

Acute Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05014230
• Other study ID #: 2106003017
• Secondary ID: K01DA048087
• Status: Recruiting
• Phase: N/A
• Start date: December 9, 2021
• Est. completion date: February 1, 2024

Study information

• Verified date: February 2023
• Source: Brown University
• Contact: Michael H Bernstein, PhD
• Phone: 401-863-7688
• Email: michael_bernstein[@]brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 155
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Lifespan Hospital System	Providence	Rhode Island

Sponsors (4)

Lead Sponsor	Collaborator
Brown University	National Institute on Drug Abuse (NIDA), Rhode Island Hospital, The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prescription Opioid Use	Quantity of Opioid Use (converted to MME when possible)	7 days
Secondary	Pain Intensity	Pain Intensity subscale of the Brief Pain Inventory	7 days
Secondary	Pain Interference	Pain interference subscale of the Brief Pain Inventory	7 days