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Clinical Trials/NCT03631251
NCT03631251
Completed
Early Phase 1

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

Brown University2 sites in 1 country10 target enrollmentAugust 17, 2018

Overview

Phase
Early Phase 1
Intervention
Open Placebo
Conditions
Hand or Wrist Surgery
Sponsor
Brown University
Enrollment
10
Locations
2
Primary Endpoint
Enrollment Percentage
Status
Completed
Last Updated
5 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
August 17, 2018
End Date
July 15, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael Bernstein

Postdoctoral Fellow

Brown University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Open Placebo

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

Intervention: Open Placebo

Outcomes

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

Study Sites (2)

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