Study of the Abuse Liability of Oxycodone HCl/Niacin in Subjects With a History of Opioid Abuse

NCT ID: NCT00699010

Last Updated: 2018-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2008-08-31

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 subjects with a history of opioid abuse.

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 receive oxycodone/niacin first followed by oxycodone with a 48 hour washout between doses. 15 subjects randomized to receive oxycodone before the oxycodone/naicin dose with a 48 hour washout between doses. The purpose of the Treatment Phase was to assess the abuse liability and abuse deterrence potential of 4 times the recommended 2-tablet dose of Acurox® Tablets 5/30 mg versus oxycodone HCl 40 mg alone (8 tablets per dose).

All 30 subjects received a single dose of each study treatment. Subjects were fasted prior to dosing on all dose days.

Conditions

Opioid Abuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Acurox 5/30mg taken first

oxycodone HCl/Niacin 5/30mg tablets; 8 tablets per dose

Group Type: ACTIVE_COMPARATOR

Acurox 5/30mg taken first

Intervention Type: DRUG

followed by oxycodone 5mg with 48 hour washout

Oxycodone 5mg taken first

oxycodone HCl 5mg tablets; 8 tablets per dose

Group Type: ACTIVE_COMPARATOR

Oxycodone 5mg taken first

Intervention Type: DRUG

followed by Acurox 5/30mg with 48 hour washout

Interventions

Acurox 5/30mg taken first

followed by oxycodone 5mg with 48 hour washout

Intervention Type: DRUG

Oxycodone 5mg taken first

followed by Acurox 5/30mg with 48 hour washout

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Acura Pharmaceuticals Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Donald R Jasinski, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Medical Center

Locations

Johns Hopkins Medical Center

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

AP-ADF-111

Identifier Type: -

Identifier Source: org_study_id