Acute PainNCT05014230
Open Label Placebo to Reduce Prescription Opioid Use
A study of Acute Pain, run by Brown University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pain
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 155 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2021to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Lifespan Hospital System
Providence, Rhode Island, 02912
Francesca Beaudoin, MD PhD, 401-519-0330, Francesca_Beaudoin@brown.edu
About this study
Official title: Acute Pain Treatment: A Randomized Controlled Trial Examining Opioids and Open 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 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.
Read the 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).
- Conditions
- Acute Pain
- Being tested
- Open Placebo, Opioid medication as part of standard care
- Keywords
- pain, placebo, analgesia, opioid
- Medical subject headings
- Acute Pain, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open PlaceboDietary supplement
Zeebo
Opioid medication as part of standard careOther
Opioid medication as prescribed by prescriber. This is not impacted by being in the research study.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual | Other | Opioid medication, as prescribed in routine care Receives: Other: Opioid medication as part of standard care |
| Open Label Placebo + Treatment as Usual | Experimental | Opioid medication, as prescribed in routine care + Honest placebos Receives: Dietary Supplement: Open Placebo; Other: Opioid medication as part of standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prescription Opioid Use
Quantity of Opioid Use (converted to MME when possible)
Measured: 7 days
Secondary outcomes (2)
Pain Intensity
Pain Intensity subscale of the Brief Pain Inventory
Measured: 7 days
Pain Interference
Pain interference subscale of the Brief Pain Inventory
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start9 Dec 2021
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), The Miriam Hospital, Rhode Island Hospital
- Responsible party
- Sponsor
- Investigators
- Michael H Bernstein, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014230
- Sponsor's protocol ID
- 2106003017
- Other IDs
- K01DA048087
- Status last verified
- Feb 2023
- First submitted
- 13 Aug 2021
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Pain Treatment: A Randomized Controlled Trial Examining Opioids and Open Placebo
- ClinicalTrials.gov ID
- NCT05014230
- Acronym / sponsor ID
- 2106003017
- Conditions
- Acute Pain
- Keywords
- pain, placebo, analgesia, opioid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), The Miriam Hospital, Rhode Island Hospital
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 20 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | Other | Other: Opioid medication as part of standard careOpioid medication, as prescribed in routine care |
| Open Label Placebo + Treatment as Usual | Experimental | Dietary Supplement: Open Placebo, Other: Opioid medication as part of standard careOpioid medication, as prescribed in routine care + Honest placebos |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open PlaceboZeebo | Dietary supplement | Open Label Placebo + Treatment as Usual |
| Opioid medication as part of standard careOpioid medication as prescribed by prescriber. This is not impacted by being in the research study. | Other | Open Label Placebo + Treatment as Usual, Treatment as Usual |
Primary outcome
Prescription Opioid Use
Time frame: 7 days
Quantity of Opioid Use (converted to MME when possible)
2 secondary outcomes
Pain Intensity
Time frame: 7 days
Pain Interference
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael H Bernstein, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Acute Pain, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael H Bernstein, PhD (401-863-7688, michael_bernstein@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prescription Opioid Use (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023; AzTrials last refreshed its copy on 7 Nov 2026.