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Trial record 33 of 58382 for:    Placebo

Using Honest Placebos to Improve Pain Management in Hand Surgery Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03631251
Recruitment Status : Not yet recruiting
First Posted : August 15, 2018
Last Update Posted : August 15, 2018
Rhode Island Hospital
Information provided by (Responsible Party):
Michael Bernstein, Brown University

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 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

Condition or disease Intervention/treatment Phase
Hand or Wrist Surgery Drug: Open Placebo Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enhancing Analgesia With Non-Deceptive Placebos: A Proof-Of-Concept Pilot Study
Estimated Study Start Date : August 17, 2018
Estimated Primary Completion Date : December 25, 2018
Estimated Study Completion Date : January 3, 2019

Arm Intervention/treatment
Experimental: Open Placebo
Open placebo in addition to the standard course of opioids. Opioids are given consistent with standard care.
Drug: Open Placebo
Open placebo in addition to the standard course of opioids. Opioids are given consistent with standard care.

Primary Outcome Measures :
  1. Enrollment Percentage [ Time Frame: Through study enrollment, 1 day ]
    Percentage of Eligible Patients who Enroll

  2. Retention Rate [ Time Frame: through study completion, approximately 2 months ]
    Percentage of Patients who are Retained at follow-up

  3. Placebo Intake [ Time Frame: Through the week following surgery, 7 days ]
    Number of Placebos Participants Take

Secondary Outcome Measures :
  1. Numeric Pain Rating Scale [ Time Frame: 7 days ]
    Single item 11-point Likert Scale from 0 to 10 assessing current day's pain where 10 represents the worst possible outcome and 0 represents the best possible outcome.

  2. Pain Interference Short Form 4a, 4-item PROMIS questionnaire [ Time Frame: 7 days ]
    How much pain has interfered with daily life on a 5-point Likert scale from 1 to 5 where 5 represents the worst possible outcome and 1 represents the best possible outcome

  3. Pain bothersomeness single-item questionnaire [ Time Frame: 7 days ]
    1-item measure assessing how bothersome the pain feels on an 11-point Likert scale from 0 to 10 where 10 represents the worst possible outcome and 0 represents the best possible outcome

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  • 18 years or older
  • English Speaking
  • Have a working phone
  • Scheduled for hand or wrist surgery
  • Able to provide informed consent

Exclusion Criteria:

  • 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

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Responsible Party: Michael Bernstein, Postdoctoral Fellow, Brown University Identifier: NCT03631251     History of Changes
Other Study ID Numbers: IRB00000556
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No