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Open Label Placebo to Reduce Prescription Opioid Use

Acute Pain Treatment: A Randomized Controlled Trial Examining Opioids and Open Placebo

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05014230
Enrollment
155
Registered
2021-08-20
Start date
2021-12-09
Completion date
2024-02-01
Last updated
2023-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain

Keywords

pain, placebo, analgesia, opioid

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.

Detailed description

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 researchers can develop 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 efficacy of using an honest placebo to relieve pain for patients with an acute pain condition. People with acute pain in the Emergency Department, or patients undergoing hand/wrist surgery, 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 regarding their pain, opioid use, and placebo use (only those assigned to take placebo pills).

Interventions

DIETARY_SUPPLEMENTOpen Placebo

Zeebo

OTHEROpioid medication as part of standard care

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

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
The Miriam Hospital
CollaboratorOTHER
Rhode Island Hospital
CollaboratorOTHER
Brown University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Prescription Opioid Use7 daysQuantity of Opioid Use (converted to MME when possible)

Secondary

MeasureTime frameDescription
Pain Intensity7 daysPain Intensity subscale of the Brief Pain Inventory
Pain Interference7 daysPain interference subscale of the Brief Pain Inventory

Countries

United States

Contacts

Primary ContactMichael H Bernstein, PhD
michael_bernstein@brown.edu401-863-7688
Backup ContactFrancesca Beaudoin, MD PhD
Francesca_Beaudoin@brown.edu401-519-0330

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026