Status:
COMPLETED
Study of the Abuse Liability of Oxycodone HCl/Niacin in Subjects With a History of Opioid Abuse
Lead Sponsor:
Acura Pharmaceuticals Inc.
Conditions:
Opioid Abuse
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the abuse liability of 4 times (8 tablets) the usual recommended dose of Acurox (oxycodone HCl 40 mg plus niacin 240 mg) versus oxycodone HCL 40 mg alone in subj...
Detailed Description
In the Treatment Phase, subjects randomly received oxycodone HCl 40 mg administered in combination with niacin 240 mg and oxycodone HCl 40 mg alone in crossover design. 15 subjects were randomized to ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00699010
Start Date
March 1 2008
End Date
August 1 2008
Last Update
October 3 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Johns Hopkins Medical Center
Baltimore, Maryland, United States, 21224