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Study of the Relative Abuse Potential of Acurox Tablets in Non-Dependent Recreational Opioid Users

Primary Purpose

Opioid Abuse

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
40/0mg taken first
80/0mg taken first
40/240mg taken first
80/480mg taken first
0/0mg taken first
Sponsored by
Acura Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Abuse focused on measuring Abuse Liability, Abuse Prevention, Abuse Resistance, Abuse Deterrence

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Lifetree Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Experimental

Experimental

Placebo Comparator

Arm Label

40/0mg taken first

80/0mg taken first

40/240mg taken first

80/480mg taken first

0/0mg taken first

Arm Description

8x oxycodone/niacin 5/0mg tablets

8x oxycodone/niacin 10/0mg tablets

8x oxycodone/niacin 5/30mg tablets

8x oxycodone/niacin 10/60mg tablets

Placebo

Outcomes

Primary Outcome Measures

Drug Liking at .5 Hours
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).

Secondary Outcome Measures

Full Information

First Posted
December 10, 2009
Last Updated
October 4, 2018
Sponsor
Acura Pharmaceuticals Inc.
Collaborators
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01030406
Brief Title
Study of the Relative Abuse Potential of Acurox Tablets in Non-Dependent Recreational Opioid Users
Official Title
A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Assess the Relative Abuse Potential of Acurox Tablets in Non-Dependent Recreational Opioid Users
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acura Pharmaceuticals Inc.
Collaborators
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Abuse
Keywords
Abuse Liability, Abuse Prevention, Abuse Resistance, Abuse Deterrence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Masking Description
Matching white tablets
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
40/0mg taken first
Arm Type
Active Comparator
Arm Description
8x oxycodone/niacin 5/0mg tablets
Arm Title
80/0mg taken first
Arm Type
Active Comparator
Arm Description
8x oxycodone/niacin 10/0mg tablets
Arm Title
40/240mg taken first
Arm Type
Experimental
Arm Description
8x oxycodone/niacin 5/30mg tablets
Arm Title
80/480mg taken first
Arm Type
Experimental
Arm Description
8x oxycodone/niacin 10/60mg tablets
Arm Title
0/0mg taken first
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
40/0mg taken first
Intervention Description
8x Oxycodone/Niacin 5/0mg tablets All arms taken with a 48 hour washout between doses
Intervention Type
Drug
Intervention Name(s)
80/0mg taken first
Intervention Description
8x Oxycodone/Niacin 10/0mg tablets All arms taken with a 48 hour washout between doses
Intervention Type
Drug
Intervention Name(s)
40/240mg taken first
Intervention Description
8x Oxycodone/Niacin 5/30mg tablets All arms taken with a 48 hour washout between doses
Intervention Type
Drug
Intervention Name(s)
80/480mg taken first
Intervention Description
8x Oxycodone/Niacin 10/60mg tablets All arms taken with a 48 hour washout between doses
Intervention Type
Drug
Intervention Name(s)
0/0mg taken first
Intervention Description
Placebo All arms taken with a 48 hour washout between doses
Primary Outcome Measure Information:
Title
Drug Liking at .5 Hours
Description
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).
Time Frame
Measure collected at 0.5 hours post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynne Webster, MD
Organizational Affiliation
Lifetree Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lifetree Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States

12. IPD Sharing Statement

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Study of the Relative Abuse Potential of Acurox Tablets in Non-Dependent Recreational Opioid Users

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