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Trial record 77 of 665 for:    OXYCODONE

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.
 
ClinicalTrials.gov Identifier: NCT00699010
Recruitment Status : Completed
First Posted : June 17, 2008
Results First Posted : October 3, 2018
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Acura Pharmaceuticals Inc.

Tracking Information
First Submitted Date  ICMJE June 13, 2008
First Posted Date  ICMJE June 17, 2008
Results First Submitted Date  ICMJE June 27, 2018
Results First Posted Date  ICMJE October 3, 2018
Last Update Posted Date October 3, 2018
Study Start Date  ICMJE March 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2018)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: June 16, 2008)
  • Evaluation of the Drug Rating Questionnaire-Subject (DRQS), and the Addiction Research Center Inventory (ARCI) [ Time Frame: Days 1, 3, 5, 7, and 9 ]
  • 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 ]
Change History Complete list of historical versions of study NCT00699010 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Abuse Liability of Oxycodone HCl/Niacin in Subjects With a History of Opioid Abuse
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Opioid Abuse
Intervention  ICMJE
  • Drug: Acurox 5/30mg taken first
    followed by oxycodone 5mg with 48 hour washout
  • Drug: Oxycodone 5mg taken first
    followed by Acurox 5/30mg with 48 hour washout
Study Arms  ICMJE
  • Active Comparator: Acurox 5/30mg taken first
    oxycodone HCl/Niacin 5/30mg tablets; 8 tablets per dose
    Intervention: Drug: Acurox 5/30mg taken first
  • Active Comparator: Oxycodone 5mg taken first
    oxycodone HCl 5mg tablets; 8 tablets per dose
    Intervention: Drug: Oxycodone 5mg taken first
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 16, 2008)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00699010
Other Study ID Numbers  ICMJE AP-ADF-111
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Acura Pharmaceuticals Inc.
Study Sponsor  ICMJE Acura Pharmaceuticals Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Donald R Jasinski, MD Johns Hopkins Medical Center
PRS Account Acura Pharmaceuticals Inc.
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP