Relieving Acute Pain (RAP) Study: A Pilot Study
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Trauma, Opioid Use, Spine Fusion
In brief
The United States (US) faces a crisis of pain management. According to the 2012 National Health Interview Survey, almost 50 million adults in the US reported having significant chronic or severe pain (Nahin 2015). Doctors in the US still prescribe opioids across the board for pain despite a growing recognition of an epidemic of opioid overdose and use disorder. Few solutions have been successfully proposed and implemented. Placebos represent a novel and potentially fruitful means of addressing this issue. However, clinicians often use placebos deceptively and with little rationale or evidence of benefit, making their use ethically problematic. In contrast with their typical current use, a provocative line of research suggests that placebos can be intentionally exploited to extend analgesic therapeutic effects. Recently, we reviewed a database of placebo studies including 22 studies in both animals and humans hinting of evidence that placebos may work as a dose extender of active painkillers. Placebos given after repeated administration of active treatments can acquire medication-like effects based on learning mechanisms. Here, we will test if dose-extending placebos are effective in relieving clinical acute pain in opioid patients with traumatic pain. Patients will be randomized to three arms. Arm 1 will be a Full Dose (FD) group, which will receive all NSAIDs as described in the Guidelines for NSAID use in Orthopedic Patients and Oxycodone (5mg). Arm 2 will be a Partial Reinforcement (PR) group, which will receive NSAIDs, Oxycodone (5mg), and placebos to reach a 50% reduction of the total intake of opioids. Finally, Arm 3 will be a Control (C) group receiving NSAIDs and placebos. Patients will be assigned to one of three arms according to a 1:1:1 schedule of randomization. Study IDs will be generated by the pharmacy and blinding will occur by ensuring that oxycodone and placebos look, smell, and taste identical. Rescue therapy will be provided as needed. This novel prospect of placebo use has the potential to change our general thinking about painkiller treatments, the typical regimens of painkiller applications, and the ways in which treatments are evaluated.
Key facts
- Study ID
- NCT03426137
- Run by
- University of Maryland, Baltimore
- People needed
- 3
- Starts
- 2018-09-17
- Expected to finish
- 2020-01-21
- Last updated by the study team
- 2021-04-27
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18-65
- Admission to The Shock Trauma Center within 72 hrs
- Any trauma requiring inpatient opioid medication
- Plan by primary service to follow the Shock Trauma Guidelines for Acute Pain in Orthopedic Injury
- Predicted length of stay greater than or equal to 2 days
You may not qualify if…
- Non English speaking
- Spine cord injury
- Severe Traumatic brain injury (based on a Glascow Coma Scale of 8 or less)
- Patient-controlled analgesia
- Admission Creatinine > 1.4
- History of chronic kidney disease
- Heroin use in the 3 months prior to admission (patient self-report)
- Severe psychiatric condition (e.g. schizophrenia, bipolar disorders, mania, autism) and /or psychiatric condition leading to treatment and/or hospitalization within the last 1 year.
- Positive toxicology screen for methadone not prescribed during current hospitalization
- Pregnancy or breast feeding
- Contraindication to NSAIDs, including high risk of bleeding or known severe coronary artery disease
- Injuries deemed non survival.
Where it is running
- University of Maryland — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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