Phase 2 N=30 Randomized Double-blind Treatment

Study of the Abuse Liability of Oxycodone HCl/Niacin in Subjects With a History of Opioid Abuse

Opioid Abuse

Bottom Line

View on ClinicalTrials.gov: NCT00699010 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2018

Primary outcome: Primary: Drug Like/Dislike Effect at 30 Minutes Post Dose (E 30 Min) — 11.7; 14.7 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Acurox 5/30mg taken first (Drug); Oxycodone 5mg taken first (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Acura Pharmaceuticals Inc.
Primary completion: Aug 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Drug Like/Dislike Effect at 30 Minutes Post Dose (E 30 Min)	11.7; 14.7	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

Subject is male or female between 18 and 55 years of age
Subject meets DSM-IV Criteria for the Diagnosis of Opioid Substance Abuse and subject is unlikely to experience an idiosyncratic reaction or respiratory depression after ingesting 40 mg of oxycodone
Body weight is not more than 20% above or below ideal body weight
Subject agrees to abstain from any Rx or OTC drugs (except as authorized by the Investigator) or alcohol
Subject is in generally good health
Subject is reliable, willing, cooperative, able to communicate effectively, and has a minimum of a 6th grade reading level
Subject has an acceptable score on the MMSE for cognitive impairment
For women of child-bearing potential: woman is not pregnant and not nursing, and is practicing an acceptable method of birth control

Exclusion Criteria

Subject has a disease that may endanger the subject or the validity of the data
Subject is currently physically dependent on opiates or alcohol
Subject was exposed to any investigational drug within 30 days prior to the inpatient phase
Subject has a history of hypersensitivity to any drug, or a known allergy to any component of the study drug formulation
Subject has a positive urine drug screen for a non-opiate drug
Subject has a predisposing condition that may place the subject at risk for receiving niacin or oxycodone, or confound the study analyses
Subject ingested niacin at doses higher than SDI within 14 days prior to the inpatient phase
Subject has an abnormal bleeding tendency

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00699010). 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.