Using Honest Placebos to Improve Pain Management in Hand Surgery Patients

NCT ID: NCT03631251

Last Updated: 2020-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-17
• Study Completion Date: 2019-07-15

Brief Summary

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 it is possible to develop new 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 feasibility of using an honest placebo to relieve pain for up to 20 real patients. People who are undergoing hand or wrist surgery or enrolled for upper extremity trauma in the Emergency Department and agree to participate will be asked to take placebo pills in addition to their standard course of opioid pills, given as part of standard care. Patients will also answer a few short questions over the phone once per day for seven days, and be invited to participate in an exit questionnaire at the end of the study. The investigators hypothesize that: 1) At least 50% of eligible participants will agree to enroll, 2) At least 80% of participants who are enrolled will be retained, and 3) Participants who are enrolled will take a placebo at least 50% of the time they also take an opioid pill

Conditions

Hand or Wrist Surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open Placebo

Open placebo in addition to the standard course of opioids. Opioids are given consistent with standard care.

Group Type: EXPERIMENTAL

Open Placebo

Intervention Type: DRUG

Open placebo in addition to the standard course of opioids. Opioids are given consistent with standard care.

Interventions

Open Placebo

Open placebo in addition to the standard course of opioids. Opioids are given consistent with standard care.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 18 years or older
• English Speaking
• Have a working phone
• Scheduled for hand or wrist surgery
• 18 years or older
• English Speaking
• Have a working phone
• Able to provide informed consent
• Present for upper extremity trauma
• Are expected to be prescribed opioids at discharge
• Are expected to be discharged from the Emergency Department

Exclusion Criteria

• Known history of Substance Use Disorder
• Chronic pain
• Chronic opioid use
• Known history of Substance Use Disorder
• Chronic pain
• Chronic opioid use
• Unlikely to follow-up (discretion of investigator and treating provider)
• Likely to receive surgical repair of the indicated injury

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

Sponsors

Rhode Island Hospital

OTHER

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: lead

Responsible Party

Michael Bernstein

Postdoctoral Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Orthopedics

East Providence, Rhode Island, United States

Miriam Hospital

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

IRB00000556

Identifier Type: -

Identifier Source: org_study_id