Open Label Placebo to Reduce Prescription Opioid Use

NCT ID: NCT05014230

Last Updated: 2023-02-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-09
• Study Completion Date: 2024-02-01

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).

Conditions

Acute Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Treatment as Usual

Opioid medication, as prescribed in routine care

Group Type: OTHER

Opioid medication as part of standard care

Intervention Type: OTHER

Opioid medication as prescribed by prescriber. This is not impacted by being in the research study.

Open Label Placebo + Treatment as Usual

Opioid medication, as prescribed in routine care + Honest placebos

Group Type: EXPERIMENTAL

Open Placebo

Intervention Type: DIETARY_SUPPLEMENT

Zeebo

Opioid medication as part of standard care

Intervention Type: OTHER

Opioid medication as prescribed by prescriber. This is not impacted by being in the research study.

Interventions

Open Placebo

Zeebo

Intervention Type: DIETARY_SUPPLEMENT

Opioid medication as part of standard care

Opioid medication as prescribed by prescriber. This is not impacted by being in the research study.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

The Miriam Hospital

OTHER

Sponsor Role: collaborator

Rhode Island Hospital

OTHER

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael H Bernstein, PhD

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

Lifespan Hospital System

Providence, Rhode Island, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michael H Bernstein, PhD

Role: CONTACT

michael_bernstein@brown.edu

401-863-7688

Francesca Beaudoin, MD PhD

Role: CONTACT

Francesca_Beaudoin@brown.edu

401-519-0330

Facility Contacts

Francesca Beaudoin, MD PhD

Role: primary

Francesca_Beaudoin@brown.edu

401-519-0330

Other Identifiers

K01DA048087

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2106003017

Identifier Type: -

Identifier Source: org_study_id