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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00699010
Recruitment Status : Completed
First Posted : June 17, 2008
Results First Posted : October 3, 2018
Last Update Posted : October 3, 2018
Information provided by (Responsible Party):
Acura Pharmaceuticals Inc.

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.

Condition or disease Intervention/treatment Phase
Opioid Abuse Drug: Acurox 5/30mg taken first Drug: Oxycodone 5mg taken first Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Acurox 5/30mg taken first
oxycodone HCl/Niacin 5/30mg tablets; 8 tablets per dose
Drug: Acurox 5/30mg taken first
followed by oxycodone 5mg with 48 hour washout

Active Comparator: Oxycodone 5mg taken first
oxycodone HCl 5mg tablets; 8 tablets per dose
Drug: Oxycodone 5mg taken first
followed by Acurox 5/30mg with 48 hour washout

Primary Outcome Measures :
  1. Drug Like/Dislike Effect at 30 Minutes Post Dose (E 30 Min) [ Time Frame: Effects assessed at 0.5 hours after dosing. ]
    "Do you dislike or like the drug effect you are feeling now?" This question was rated on a 1 to 29 point VAS scale that was anchored in the center with "neither like nor dislike" (14), on the left with "dislike an awful lot" (1), and on the right with "like an awful lot" (29).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00699010

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United States, Maryland
Johns Hopkins Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Acura Pharmaceuticals Inc.
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Principal Investigator: Donald R Jasinski, MD Johns Hopkins Medical Center

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Responsible Party: Acura Pharmaceuticals Inc. Identifier: NCT00699010    
Other Study ID Numbers: AP-ADF-111
First Posted: June 17, 2008    Key Record Dates
Results First Posted: October 3, 2018
Last Update Posted: October 3, 2018
Last Verified: October 2008
Keywords provided by Acura Pharmaceuticals Inc.:
Abuse Liability
Abuse Prevention
Abuse Resistance
Abuse Deterrence
Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Growth Substances