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

Information source: Acura Pharmaceuticals Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

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

Summary

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.

Clinical Details

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)

Eligibility

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

Locations and Contacts

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

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

Page last updated: August 23, 2015

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