NCT05014230

Brief Summary

The goal of the proposed study is to examine the efficacy of using an honest placebo to relieve pain for patients with an acute pain condition. People with acute pain will receive their standard dose of opioid medication for pain management. In addition, some people will be asked to take placebo pills, honestly described as placebos, as well. Patients will answer a few short questions over the phone once per day for seven days about pain and opioid use. The investigators hypothesize that participants in the open label placebo group will take fewer opioids and have less pain than those in the treatment as usual group.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
155

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 20, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

December 9, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

February 22, 2023

Status Verified

February 1, 2023

Enrollment Period

2.1 years

First QC Date

August 13, 2021

Last Update Submit

February 21, 2023

Conditions

Acute Pain

Keywords

painplaceboanalgesiaopioid

Outcome Measures

Primary Outcomes (1)

  • Prescription Opioid Use

    Quantity of Opioid Use (converted to MME when possible)

    7 days

Secondary Outcomes (2)

  • Pain Intensity

    7 days

  • Pain Interference

    7 days

Study Arms (2)

Treatment as Usual

OTHER

Opioid medication, as prescribed in routine care

Other: Opioid medication as part of standard care

Open Label Placebo + Treatment as Usual

EXPERIMENTAL

Opioid medication, as prescribed in routine care + Honest placebos

Dietary Supplement: Open PlaceboOther: Opioid medication as part of standard care

Interventions

Open PlaceboDIETARY_SUPPLEMENT

Zeebo

Open Label Placebo + Treatment as Usual
Opioid medication as part of standard careOTHER

Opioid medication as prescribed by prescriber. This is not impacted by being in the research study.

Open Label Placebo + Treatment as UsualTreatment as Usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • English Speaking
  • Has a working smart-phone
  • Able to provide informed consent
  • Present for upper or lower extremity fracture (ED sample only) or for hand or wrist surgery (hand surgery sample only)
  • Are expected to be prescribed opioids at discharge
  • Are expected to be discharged from the Emergency Department (ED sample only)
  • Intends to take 1 or more doses of opioid medication as prescribed

You may not qualify if:

  • Chronic opioid use
  • Unlikely to follow-up (discretion of investigator and treating provider)
  • Having been diagnosed with a psychotic disorder
  • Having a current medical marijuana prescription
  • Currently receiving worker's compensation or intending to apply for worker's compensation
  • History of opioid use disorder
  • Allergy to opioid medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lifespan Hospital System

Providence, Rhode Island, 02912, United States

RECRUITING

MeSH Terms

Conditions

Acute PainPainAgnosia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • Michael H Bernstein, PhD

    Brown University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael H Bernstein, PhD

CONTACT

401-863-7688michael_bernstein@brown.edu

Francesca Beaudoin, MD PhD

CONTACT

401-519-0330Francesca_Beaudoin@brown.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2021

First Posted

August 20, 2021

Study Start

December 9, 2021

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

February 22, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)