Phase 2
N=49
Study of the Relative Abuse Potential of Acurox Tablets in Non-Dependent Recreational Opioid Users
Opioid Abuse
Bottom Line
View on ClinicalTrials.gov: NCT01030406 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Drug Liking at .5 Hours — 66.0; 74.7; 47.7; 40.9 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 40/0mg taken first (Drug); 80/0mg taken first (Drug); 40/240mg taken first (Drug); 80/480mg taken first (Drug); 0/0mg taken first (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Acura Pharmaceuticals Inc.
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Drug Liking at .5 Hours |
66.0; 74.7; 47.7; 40.9; 50.3 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01030406). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.