The purpose of this study is to assess the abuse liability of 4 times (8 tablets) the usual recommended dose of Acurox (oxycodone HCl 40 mg plus niacin 240 mg) versus oxycodone HCL 40 mg alone in subjects with a history of opioid abuse.
In the Treatment Phase, subjects randomly received oxycodone HCl 40 mg administered in combination with niacin 240 mg and oxycodone HCl 40 mg alone in crossover design. 15 subjects were randomized to receive oxycodone/niacin first followed by oxycodone with a 48 hour washout between doses. 15 subjects randomized to receive oxycodone before the oxycodone/naicin dose with a 48 hour washout between doses. The purpose of the Treatment Phase was to assess the abuse liability and abuse deterrence potential of 4 times the recommended 2-tablet dose of Acurox® Tablets 5/30 mg versus oxycodone HCl 40 mg alone (8 tablets per dose). All 30 subjects received a single dose of each study treatment. Subjects were fasted prior to dosing on all dose days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
followed by oxycodone 5mg with 48 hour washout
followed by Acurox 5/30mg with 48 hour washout
Johns Hopkins Medical Center
Baltimore, Maryland, United States
Drug Like/Dislike Effect at 30 Minutes Post Dose (E 30 Min)
"Do you dislike or like the drug effect you are feeling now?" This question was rated on a 1 to 29 point VAS scale that was anchored in the center with "neither like nor dislike" (14), on the left with "dislike an awful lot" (1), and on the right with "like an awful lot" (29).
Time frame: Effects assessed at 0.5 hours after dosing.
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