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

Completed · Phase 2

Conditions studied: Opioid Abuse

In brief

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.

Key facts

Study ID

NCT00699010

Run by

Acura Pharmaceuticals Inc.

People needed

30

Starts

2008-03-01

Expected to finish

2008-08-01

Last updated by the study team

2018-10-03

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 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

You may not qualify if…

• 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

Where it is running

• Johns Hopkins Medical Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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