Clinical trial NCT01030406: Study of the Relative Abuse Potential of Acurox Tablets in Non-Dependent Recreational Opioid Users
Official title: A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Assess the Relative Abuse Potential of Acurox Tablets in Non-Dependent Recreational Opioid Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid Abuse
Keywords: Abuse Liability
Abuse Prevention
Abuse Resistance
Abuse Deterrence
Lead sponsor: Acura Pharmaceuticals Inc.
Sponsor class: INDUSTRY
Collaborators: name: King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
First posted: 2009-12-11
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to compare the relative abuse potential of two different doses of orally administered Acurox Tablets to orally administered immediate-release (IR) oxycodone HCl tablets in non-dependent recreational opioid users.

Detailed description: In the tretament phase, 5 treatments administered were oxycodone HCl/niacin tablets as follows: (A) 40/0 mg, (B) 80/0 mg, (C) (40/240 mg, (D) 80/480 mg and (E) 0/0 mg. Each treatment was administered as a single dose of 8 tablets once a day at approximately the same time each day. All doses were given with water, and all 8 tablets were to be swallowed in 5 minutes. Doses were separated by 48 (± 1) hours. All subjects received each treatment in a randomized sequence using a Williams design.

Eligibility criteria: Inclusion Criteria:

* Subject is male or female between 18 and 55 years old.
* Subject is in generally good health, including no history of pulmonary disease, and has a body mass index (BMI) within 18-33 kg/m2.
* Subject is a recreational opioid user (i.e., at least 10 occasions within the past 12 months, and at least 1 within the past 12 weeks) who is NOT physically dependent on opioids (per Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision \[DSM-IV-TR\]); is able to speak, read, and understand English; and will provide written informed consent.
* Subject has a minimum of a 6th grade reading level as determined by the Investigator or by the Rapid Estimation of Adult Literacy in Medicine (REALM).

Exclusion Criteria:

* History or current diagnosis of substance dependence (except nicotine and caffeine) and/or alcohol abuse according to the criteria of DSM-IV-TR.
* History or current diagnosis of neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, hematologic, pulmonary, or metabolic disease.
* Known allergy or history of hypersensitivity to oxycodone HCl, other opioids, or any component of Acurox Tablets.

Primary outcomes:
measure: Drug Liking at .5 Hours
timeFrame: Measure collected at 0.5 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Lifetree Clinical Research
state: Utah
Study officials:
affiliation: Lifetree Clinical Research
name: Lynne Webster, MD
role: PRINCIPAL_INVESTIGATOR
References: