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
Results First Posted : October 3, 2018
Last Update Posted : October 3, 2018
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Sponsor:
Acura Pharmaceuticals Inc.
Information provided by (Responsible Party):
Acura Pharmaceuticals Inc.
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Study Type | Interventional |
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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 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Acurox 5/30mg Taken First | Oxycodone 5mg Taken First |
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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 |
Baseline Characteristics
Arm/Group Title | Acurox 5/30mg Taken First | Oxycodone 5mg Taken First | Total | |
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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 | |
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Recreational Drug Abusers
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 15 participants | 15 participants | 30 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
15 100.0%
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15 100.0%
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30 100.0%
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>=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 15 participants | 15 participants | 30 participants | |
Female |
2 13.3%
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2 13.3%
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4 13.3%
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Male |
13 86.7%
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13 86.7%
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26 86.7%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 15 participants | 15 participants | 30 participants |
15 | 15 | 39 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Dr. Ron Spivey |
Organization: | Acura Pharma |
Phone: | 847-705-7709 |
EMail: | rspivey@acurapharm.com |
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 |