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Baltimore, Maryland 21224


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.


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



Primary Contact:

Principal Investigator
Donald R Jasinski, MD
Johns Hopkins Medical Center

Backup Contact:


Location Contact:

Baltimore, Maryland 21224
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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