Using Honest Placebos to Improve Pain Management in Hand Surgery Patients

NCT03631251 | Completed Early Phase 1

• 1 other identifier: IRB00000556
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (4)

• Enrollment Percentage

  Percentage of Eligible Patients who Enroll

  Through study enrollment, 1 day

• Retention Rate

  Percentage of Patients who are Retained at follow-up

  through study completion, approximately 2 months

• Placebo Intake

  Number of Placebos Participants Take

  7 days

• Placebo Analgesia

  Analgesia associated with placebo pills

  7 days

Study Arms (1)

Open Placebo

EXPERIMENTAL

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

Drug: Open Placebo

Interventions

Open Placebo DRUG

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

Open Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• English Speaking
• Have a working phone
• Scheduled for hand or wrist surgery
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brown University: lead
• Rhode Island Hospital: collaborator

Study Sites (2)

University Orthopedics

East Providence, Rhode Island, 02915, United States

Location

Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Fellow

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 15, 2018
• Study Start: August 17, 2018
• Primary Completion: July 15, 2019
• Study Completion: July 15, 2019
• Last Updated: July 9, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)