Addiction Clinical Trial
Official title:
Reducing the Abuse Liability of Prescription Opioids
Opioid (commonly called narcotic) pain medicines are, after marijuana, the most commonly
abused substances in the United States. Patients who take opioids for legitimate reasons may
become addicted; for example, as many as 1 in 4 patients meet the criteria for current opioid
dependence. It is very important that a way is found to provide pain relief while minimizing
the addiction potential of these widely used pain medications.
The study aim to find out if the use of another type of medication given in addition to an
opioid will reduce the addiction potential of the opioid.
The study is trying to find out if the ability of the opioid to relieve pain is changed when
given with the other medication, and to see if the euphoric sensation or "liking" of the
opioid pain medication is reduced when taken with the other medication.
This study involves the use of an investigational combination of drugs. "Oxycodone with
Risperidone" and "Oxycodone with Ziprasidone" are called "Investigational" because the U.S.
Food & Drug Administration (FDA) has not approved these drug combinations for the purpose of
this study. Individually, each of these drugs is approved by the FDA for other reasons (i.e.
oxycodone as a painkiller, while risperidone and ziprasidone are approved as anti-psychotic
medications), but the administration of these drugs together has not been studied before or
been approved by the FDA for this purpose.
This is the first study involving humans to examine the safety of this combination of drugs
and how they work together. The goal of the study is to find out what effects, good and/or
bad, it has on people who take them. Because the combination has not been studied in humans
before, information about the safety and effectiveness is incomplete and all of the side
effects are not yet known.
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