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

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ClinicalTrials.gov Identifier: NCT00699010
Recruitment Status : Completed
First Posted : June 17, 2008
Last Update Posted : October 23, 2008
Sponsor:
Information provided by:
Acura Pharmaceuticals Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Opioid Abuse Drug: Niacin Drug: Oxycodone HCL plus Niacin Drug: Placebo Drug: Oxycodone HCl Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated 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

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Evaluation of the Drug Rating Questionnaire-Subject (DRQS), and the Addiction Research Center Inventory (ARCI) [ Time Frame: Days 1, 3, 5, 7, and 9 ]
  2. 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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT00699010


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

Responsible Party: Donald R. Jasinski, MD, Johns Hopkins Medical Center
ClinicalTrials.gov Identifier: NCT00699010     History of Changes
Other Study ID Numbers: AP-ADF-111
First Posted: June 17, 2008    Key Record Dates
Last Update Posted: October 23, 2008
Last Verified: October 2008

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

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Oxycodone
Niacin
Niacinamide
Nicotinic Acids
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances