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Trial record 1 of 1 for:    NCT01030406
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Study of the Relative Abuse Potential of Acurox Tablets in Non-Dependent Recreational Opioid Users

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ClinicalTrials.gov Identifier: NCT01030406
Recruitment Status : Completed
First Posted : December 11, 2009
Results First Posted : November 1, 2018
Last Update Posted : November 1, 2018
Sponsor:
Collaborator:
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Acura Pharmaceuticals Inc.

Tracking Information
First Submitted Date  ICMJE December 10, 2009
First Posted Date  ICMJE December 11, 2009
Results First Submitted Date  ICMJE June 27, 2018
Results First Posted Date  ICMJE November 1, 2018
Last Update Posted Date November 1, 2018
Study Start Date  ICMJE January 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2018)
Drug Liking at .5 Hours [ Time Frame: Measure collected at 0.5 hours post-dose ]
Drug Liking/Disliking Assessment on a 101 point bipolar visual analog scale (VAS) used to assess response to the question "Do you dislike or like the drug effect you are feeling now?" and anchored in the center with "Neither like nor dislike" (score of 50), on the left with "Dislike an awful lot" (score of 0) and on the right with "Like an awful lot" (score of 100).
Original Primary Outcome Measures  ICMJE
 (submitted: December 10, 2009)
Drug Liking/Disliking [ Time Frame: 0.5,1,1.5, 2,3,4,5,6,8, and 12 hours post-dose ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2009)
  • Take Drug Again Assessment (TDAA) [ Time Frame: 1, 2, and 8 hours post-dose ]
  • Global Assessment of Overall Drug Liking [ Time Frame: 12 hours post-dose ]
  • Pupillometry [ Time Frame: pre-dose and 0.5,1,1.5,2,3,4,5,6,8, and 12 hours post-dose ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Relative Abuse Potential of Acurox Tablets in Non-Dependent Recreational Opioid Users
Official Title  ICMJE A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Assess the Relative Abuse Potential of Acurox Tablets in Non-Dependent Recreational Opioid Users
Brief Summary The primary objective of this study is to compare the relative abuse potential of two different doses of orally administered Acurox Tablets to orally administered immediate-release (IR) oxycodone HCl tablets in non-dependent recreational opioid users.
Detailed Description In the tretament phase, 5 treatments administered were oxycodone HCl/niacin tablets as follows: (A) 40/0 mg, (B) 80/0 mg, (C) (40/240 mg, (D) 80/480 mg and (E) 0/0 mg. Each treatment was administered as a single dose of 8 tablets once a day at approximately the same time each day. All doses were given with water, and all 8 tablets were to be swallowed in 5 minutes. Doses were separated by 48 (± 1) hours. All subjects received each treatment in a randomized sequence using a Williams design.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Matching white tablets
Primary Purpose: Treatment
Condition  ICMJE Opioid Abuse
Intervention  ICMJE
  • Drug: 40/0mg taken first
    8x Oxycodone/Niacin 5/0mg tablets All arms taken with a 48 hour washout between doses
  • Drug: 80/0mg taken first
    8x Oxycodone/Niacin 10/0mg tablets All arms taken with a 48 hour washout between doses
  • Drug: 40/240mg taken first
    8x Oxycodone/Niacin 5/30mg tablets All arms taken with a 48 hour washout between doses
  • Drug: 80/480mg taken first
    8x Oxycodone/Niacin 10/60mg tablets All arms taken with a 48 hour washout between doses
  • Drug: 0/0mg taken first
    Placebo All arms taken with a 48 hour washout between doses
Study Arms  ICMJE
  • Active Comparator: 40/0mg taken first
    8x oxycodone/niacin 5/0mg tablets
    Intervention: Drug: 40/0mg taken first
  • Active Comparator: 80/0mg taken first
    8x oxycodone/niacin 10/0mg tablets
    Intervention: Drug: 80/0mg taken first
  • Experimental: 40/240mg taken first
    8x oxycodone/niacin 5/30mg tablets
    Intervention: Drug: 40/240mg taken first
  • Experimental: 80/480mg taken first
    8x oxycodone/niacin 10/60mg tablets
    Intervention: Drug: 80/480mg taken first
  • Placebo Comparator: 0/0mg taken first
    Placebo
    Intervention: Drug: 0/0mg 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: October 4, 2018)
49
Original Estimated Enrollment  ICMJE
 (submitted: December 10, 2009)
60
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject is male or female between 18 and 55 years old.
  • Subject is in generally good health, including no history of pulmonary disease, and has a body mass index (BMI) within 18-33 kg/m2.
  • Subject is a recreational opioid user (i.e., at least 10 occasions within the past 12 months, and at least 1 within the past 12 weeks) who is NOT physically dependent on opioids (per Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision [DSM-IV-TR]); is able to speak, read, and understand English; and will provide written informed consent.
  • Subject has a minimum of a 6th grade reading level as determined by the Investigator or by the Rapid Estimation of Adult Literacy in Medicine (REALM).

Exclusion Criteria:

  • History or current diagnosis of substance dependence (except nicotine and caffeine) and/or alcohol abuse according to the criteria of DSM-IV-TR.
  • History or current diagnosis of neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, hematologic, pulmonary, or metabolic disease.
  • Known allergy or history of hypersensitivity to oxycodone HCl, other opioids, or any component of Acurox Tablets.
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 NCT01030406
Other Study ID Numbers  ICMJE AP-ADF-114
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 King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator: Lynne Webster, MD Lifetree Clinical Research
PRS Account Acura Pharmaceuticals Inc.
Verification Date March 2010

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