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
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