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

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Acura Pharmaceuticals Inc.
• Treatments: Niacin; Niacinamide; Nicotinic Acids; Oxycodone

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