Study of the Relative Abuse Potential of Acurox Tablets in Non-Dependent Recreational Opioid Users
Completed · Phase 2 · Has a placebo group
Conditions studied: Opioid Abuse
In brief
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.
Key facts
- Study ID
- NCT01030406
- Run by
- Acura Pharmaceuticals Inc.
- People needed
- 49
- Starts
- 2010-01-01
- Expected to finish
- 2010-02-01
- Last updated by the study team
- 2018-11-01
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- Lifetree Clinical Research — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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