Completed

NCT Number: NCT03631251

Using Honest Placebos to Improve Pain Management in Hand Surgery Patients

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

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Key information

Conditions

Hand or Wrist Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University Orthopedics, East Providence, Rhode Island, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

, University Orthopedics & Department of Plastic & Reconstructive Surgery:

18 years or older
English Speaking
Have a working phone
Scheduled for hand or wrist surgery
Able to provide informed consent Inclusion Criteria, Miriam Hospital Emergency Department
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

, University Orthopedics & Department of Plastic & Reconstructive Surgery::

Known history of Substance Use Disorder
Chronic pain
Chronic opioid use
The prescribing physician deems opioid medication not appropriate as part of standard care for any reason Exclusion Criteria, Miriam Hospital Emergency Department
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

Treatment and study plan

Open Placebo

Drug

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

Primary outcomes

Enrollment Percentage

Time frame: Through study enrollment, 1 day

Percentage of Eligible Patients who Enroll
Retention Rate

Time frame: through study completion, approximately 2 months

Percentage of Patients who are Retained at follow-up
Placebo Intake

Time frame: 7 days

Number of Placebos Participants Take
Placebo Analgesia

Time frame: 7 days

Analgesia associated with placebo pills

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

Rhode Island Hospital

Registry information

Official study title

Enhancing Analgesia With Non-Deceptive Placebos: A Proof-Of-Concept Pilot Study

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Aug 15, 2018
Registry last updated: Jul 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.