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

This study has been completed.
Information provided by:
Acura Pharmaceuticals Inc. Identifier:
First received: June 13, 2008
Last updated: October 22, 2008
Last verified: October 2008

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.

Condition Intervention Phase
Opioid Abuse
Drug: Niacin
Drug: Oxycodone HCL plus Niacin
Drug: Placebo
Drug: Oxycodone HCl
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Further study details as provided by Acura Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Evaluation of the Drug Rating Questionnaire-Subject (DRQS), and the Addiction Research Center Inventory (ARCI) [ Time Frame: Days 1, 3, 5, 7, and 9 ] [ Designated as safety issue: Yes ]
  • Evaluation of the DRQS, the ARCI, the Street Value Assessment Questionnaire (SVAQ), and the Treatment Enjoyment Assessment Questionnaire (TEAQ) [ Time Frame: Day 1, 3, 5, 7, 8, 9, and 10 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: March 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: Niacin
Niacin 240 mg every 48 hours
Active Comparator: B Drug: Oxycodone HCL plus Niacin
Oxycodone HCL 40 mg plus Niacin 240 mg every 48 hours
Placebo Comparator: C Drug: Placebo
Placebo every 48 hours
Active Comparator: D Drug: Oxycodone HCL plus Niacin
Oxycodone HCl 40 mg plus Niacin 240 mg every 48 hours
Active Comparator: E Drug: Oxycodone HCl
Oxycodone HCl 40 mg every 48 hours


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its identifier: NCT00699010

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

No publications provided

Responsible Party: Donald R. Jasinski, MD, Johns Hopkins Medical Center Identifier: NCT00699010     History of Changes
Other Study ID Numbers: AP-ADF-111
Study First Received: June 13, 2008
Last Updated: October 22, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Acura Pharmaceuticals Inc.:
Abuse Liability
Abuse Prevention
Abuse Resistance
Abuse Deterrence

Additional relevant MeSH terms:
Substance-Related Disorders
Mental Disorders
Nicotinic Acids
Analgesics, Opioid
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents processed this record on April 14, 2014