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Study of the Abuse Liability of Oxycodone HCl/Niacin in Subjects With a History of Opioid Abuse
This study has been completed.
Study NCT00699010   Information provided by Acura Pharmaceuticals Inc.
First Received: June 13, 2008   Last Updated: October 22, 2008   History of Changes

June 13, 2008
October 22, 2008
March 2008
August 2008   (final data collection date for primary outcome measure)
  • Evaluation of the Drug Rating Questionnaire-Subject (DRQS), and the Addiction Research Center Inventory (ARCI) [ Time Frame: Days 1, 3, 5, 7, and 9 ] [ Designated as safety issue: Yes ]
  • Evaluation of the DRQS, the ARCI, the Street Value Assessment Questionnaire (SVAQ), and the Treatment Enjoyment Assessment Questionnaire (TEAQ) [ Time Frame: Day 1, 3, 5, 7, 8, 9, and 10 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00699010 on ClinicalTrials.gov Archive Site
 
 
 
Study of the Abuse Liability of Oxycodone HCl/Niacin in Subjects With a History of Opioid Abuse
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

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.

 
Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study
Opioid Abuse
  • Drug: Niacin
  • Drug: Oxycodone HCL plus Niacin
  • Drug: Placebo
  • Drug: Oxycodone HCl
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
30
August 2008
August 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00699010
Donald R. Jasinski, MD, Johns Hopkins Medical Center
AP-ADF-111
Acura Pharmaceuticals Inc.
 
Principal Investigator: Donald R Jasinski, MD Johns Hopkins Medical Center
Acura Pharmaceuticals Inc.
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP