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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.
 
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.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Opioid Abuse
Interventions Drug: Acurox 5/30mg taken first
Drug: Oxycodone 5mg taken first
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Acurox 5/30mg Taken First Oxycodone 5mg Taken First
Hide Arm/Group Description Oxycodone HCl/Niacin 5/30mg; 8 tablet dose followed by oxycodone 5mg with 48 hour washout Oxycodone Hcl 5mg; 8 tablet dose follwed by Acurox 5/30mg with 48 hour washout
Period Title: Overall Study
Started 15 15
Completed 15 15
Not Completed 0 0
Arm/Group Title Acurox 5/30mg Taken First Oxycodone 5mg Taken First Total
Hide Arm/Group Description Oxycodone HCL/Niacin 5/30mg; 8 tablet dose followed by Oxycodone 5mg with 48 hour washout Oxycodone HCL 5mg; 8 tablet dose followed by Acurox 5/30mg with 48 hour washout Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
Recreational Drug Abusers
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
 100.0%
15
 100.0%
30
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
44.7  (5.5) 44.7  (5.5) 44.7  (5.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
2
  13.3%
2
  13.3%
4
  13.3%
Male
13
  86.7%
13
  86.7%
26
  86.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 15 participants 30 participants
15 15 39
1.Primary Outcome
Title Drug Like/Dislike Effect at 30 Minutes Post Dose (E 30 Min)
Hide Description "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).
Time Frame Effects assessed at 0.5 hours after dosing.
Hide Outcome Measure Data
Hide Analysis Population Description
Study completers and per protocol
Arm/Group Title Acurox 5/30mg Oxycodone 5mg
Hide Arm/Group Description:
Oxycodone HCL/Niacin 5/30mg; 8 tablet dose
Oxycodone 5mg; 8 tablet dose
Overall Number of Participants Analyzed 30 30
Mean (Standard Error)
Unit of Measure: score on a scale
11.7  (1.0) 14.7  (1.0)
Time Frame 11 days. Doses taken 1 per day with a 48 hours washout
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Acurox 5/30mg Oxycodone 5mg
Hide Arm/Group Description Oxycodone HCL/Niacin 5/30mg; 8 tablet dose Oxycodone HCl 5mg; 8 tablet dose
All-Cause Mortality
Acurox 5/30mg Oxycodone 5mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)      0/30 (0.00%)    
Hide Serious Adverse Events
Acurox 5/30mg Oxycodone 5mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/30 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Acurox 5/30mg Oxycodone 5mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/30 (93.33%)      29/30 (96.67%)    
Gastrointestinal disorders     
Nausea † 1  8/30 (26.67%)  8 9/30 (30.00%)  9
Vomiting † 1  4/30 (13.33%)  4 3/30 (10.00%)  3
Nervous system disorders     
Euphoria † 1  13/30 (43.33%)  13 15/30 (50.00%)  15
Somnolence † 1  8/30 (26.67%)  8 9/30 (30.00%)  9
Headache † 1  8/30 (26.67%)  8 7/30 (23.33%)  7
Dizziness † 1  6/30 (20.00%)  6 1/30 (3.33%)  1
Skin and subcutaneous tissue disorders     
Pruritis † 1  21/30 (70.00%)  21 21/30 (70.00%)  21
Paraesthesia † 1  11/30 (36.67%)  11 3/30 (10.00%)  3
Vascular disorders     
Flushing † 1 [1]  23/30 (76.67%)  23 5/30 (16.67%)  5
1
Term from vocabulary, MedDRA (10.0)
†
Indicates events were collected by systematic assessment
[1]
Flushing
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Ron Spivey
Organization: Acura Pharma
Phone: 847-705-7709
EMail: rspivey@acurapharm.com
Layout table for additonal information
Responsible Party: Acura Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00699010    
Other Study ID Numbers: AP-ADF-111
First Submitted: June 13, 2008
First Posted: June 17, 2008
Results First Submitted: June 27, 2018
Results First Posted: October 3, 2018
Last Update Posted: October 3, 2018