Clinical trial NCT05014230: Open Label Placebo to Reduce Prescription Opioid Use
Official title: Acute Pain Treatment: A Randomized Controlled Trial Examining Opioids and Open Placebo
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Pain
Keywords: pain
placebo
analgesia
opioid
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: The Miriam Hospital
name: Rhode Island Hospital
First posted: 2021-08-20
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility 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

Primary outcomes:
measure: Prescription Opioid Use
timeFrame: 7 days
Secondary outcomes:
measure: Pain Intensity
timeFrame: 7 days
measure: Pain Interference
timeFrame: 7 days
Other outcomes:
Locations:
city: Providence
country: United States
facility: Lifespan Hospital System
state: Rhode Island
Study officials:
affiliation: Brown University
name: Michael H Bernstein, PhD
role: PRINCIPAL_INVESTIGATOR
References: