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

Condition(s) targeted: Opioid Abuse

Intervention: Niacin (Drug); Oxycodone HCL plus Niacin (Drug); Placebo (Drug); Oxycodone HCL plus Niacin (Drug); Oxycodone HCl (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Acura Pharmaceuticals Inc.

Official(s) and/or principal investigator(s):
Donald R Jasinski, MD, Principal Investigator, Affiliation: Johns Hopkins Medical Center

The purpose of this study is: (1) to assess the effect of oxycodone HCl on niacin-induced dysphoric effects when oxycodone HCl is administered in combination with niacin in subjects with a history of opioid abuse; (2) to assess the abuse liability of 4 times 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.

Official title: A Phase II, Single-Center, Randomized, Double-Blind Assessment of the Abuse Liability of Acurox (Oxycodone HCl and Niacin) Tablets in Subjects With a History of Opioid Abuse

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Evaluation of the Drug Rating Questionnaire-Subject (DRQS), and the Addiction Research Center Inventory (ARCI)

Evaluation of the DRQS, the ARCI, the Street Value Assessment Questionnaire (SVAQ), and the Treatment Enjoyment Assessment Questionnaire (TEAQ)

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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

Johns Hopkins Medical Center, Baltimore, Maryland 21224, United States

Starting date: March 2008
Last updated: October 22, 2008