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.
Phase:
Phase 2
Details
Lead Sponsor:
University of Maryland University of Maryland, Baltimore