The consequences of prescription opioid abuse are serious and the number of deaths from
unintended overdose have quadrupled over the last 15+ years. Opioid analgesics remain among
the most commonly abused class of substances in the United States. Moreover, patients who
take pain medications for legitimate reasons may develop an opioid use disorder (OUD), with
as many as 1 in 4 patients becoming dependent on their pain medications. Because of changing
access to prescription opioid analgesics due to an increasingly negative prescribing climate
and changes in guidelines, patients often turn to heroin, with an estimated 1 in 15 pain
patients trying heroin within 10 years. Pain is a symptom that can be severely debilitating
and needs to be treated adequately to improve the quality of life. Clinicians, then, are in a
proverbial "catch-22" situation whereby treating a patient's chronic pain also exposes them
to medications with substantial abuse liability and overdose risk. In this proposal, a method
aimed at reducing the abuse potential of prescription opioid medications, without altering
their analgesic efficacy, is described.
The study team hypothesize that this can be accomplished by administering a
fixed-dose-combination of an opioid with an atypical antipsychotic drug, in the same pill or
capsule.
Phase:
Early Phase 1
Details
Lead Sponsor:
The University of Texas Health Science Center at San Antonio