Recruiting

Open Label

Sponsor:

Brown University

Code:

NCT05014230

Conditions

Acute Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Open Placebo

Opioid medication as part of standard care

Study Details

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.

Conditions

Acute Pain

Study ID

NCT05014230

Start date

Dec 9, 2021

Status verified date

Feb, 2023

Completion date

Feb 1, 2024

Anticipated

Primary completion date

Feb 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion

  • 18 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

Exclusion

  • 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

Study Design

Enrollment

155 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: Treatment as Usual

Opioid medication, as prescribed in routine care

experimental: Open Label Placebo + Treatment as Usual

Opioid medication, as prescribed in routine care + Honest placebos

Interventions

Open Placebo

Zeebo

Opioid medication as part of standard care

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

Primary outcome measure

  • Prescription Opioid Use [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

Locations

Lifespan Hospital System

Recruiting

Providence, Rhode Island, United States, 02912

Contacts

More Information

Sponsor

Brown University

Last update posted

Feb 22, 2023

Last verified

Feb, 2023

Keywords

  • pain
  • placebo
  • analgesia
  • opioid

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brown University on 2023-02-22.