Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Baltimore, Maryland 21224


Purpose:

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.


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


NCT ID:

NCT00699010


Primary Contact:

Principal Investigator
Donald R Jasinski, MD
Johns Hopkins Medical Center


Backup Contact:

N/A


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

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.