Substance Abuse Clinical Trial
Official title:
A Single-site, Randomized, Double-blind, Double-dummy, Active-comparator, Placebo-controlled, 3-way Crossover Trial in Adult Non-dependent Recreational Opioid Users to Compare the Intranasal Abuse Potential of Immediate Release Abuse-deterrent and Standard Formulations of Oxycodone
The trial comprises an Enrollment Visit, a Qualification Phase, a Treatment Phase (including
3 treatment periods), a Final Examination, and a Follow-up Phone Call.
The Qualification Phase includes a naloxone challenge test (to verify that participants are
not opioid-dependent) and a drug discrimination test (to determine whether or not
participants are able to distinguish intranasally administered active drug from placebo).
Participants will be randomized to receive a single intranasal dose each of oxycodone active
pharmaceutical ingredient (API) and matching placebo in a double-blind manner. The total mass
of each single dose will be 30 milligrams.
Participants who successfully complete the Qualification Phase are eligible to be included in
the Treatment Phase. During the Treatment Phase, participants will receive test product,
comparator, and placebo following a randomized, double-blind, double-dummy, 3-way crossover
design. Participants will receive a single intranasal dose of each of the treatments
(combined doses of investigational medicinal product {IMP}) on Day 1, Day 4, and Day 7 of the
Treatment Phase. A single dose of a treatment is defined as insufflation of single doses of
the 2 applicable IMPs in quick succession. The 2 applicable IMPs must be insufflated in the
following pre-defined order. Oxycodone API or placebo to match oxycodone API must always be
insufflated first. Oxycodone immediate release (IR) abuse-deterrent formulation (ADF) or
placebo to match oxycodone IR ADF must always be insufflated second. The total mass of each
single dose of treatment will be 570 milligrams.
n/a
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