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