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

October 4, 2018 updated by: Acura Pharmaceuticals Inc.

A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Assess the Relative Abuse Potential of Acurox Tablets in Non-Dependent Recreational Opioid Users

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

49

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Lifetree Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 40/0mg taken first
8x oxycodone/niacin 5/0mg tablets
Drug: 40/0mg taken first
8x Oxycodone/Niacin 5/0mg tablets All arms taken with a 48 hour washout between doses
Active Comparator: 80/0mg taken first
8x oxycodone/niacin 10/0mg tablets
Drug: 80/0mg taken first
8x Oxycodone/Niacin 10/0mg tablets All arms taken with a 48 hour washout between doses
Experimental: 40/240mg taken first
8x oxycodone/niacin 5/30mg tablets
Drug: 40/240mg taken first
8x Oxycodone/Niacin 5/30mg tablets All arms taken with a 48 hour washout between doses
Experimental: 80/480mg taken first
8x oxycodone/niacin 10/60mg tablets
Drug: 80/480mg taken first
8x Oxycodone/Niacin 10/60mg tablets All arms taken with a 48 hour washout between doses
Placebo Comparator: 0/0mg taken first
Placebo
Drug: 0/0mg taken first
Placebo All arms taken with a 48 hour washout between doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Measure collected at 0.5 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acura Pharmaceuticals Inc.

Collaborators

King Pharmaceuticals is now a wholly owned subsidiary of Pfizer

Investigators

  • Principal Investigator: Lynne Webster, MD, Lifetree Clinical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

December 10, 2009

First Submitted That Met QC Criteria

December 10, 2009

First Posted (Estimate)

December 11, 2009

Study Record Updates

Last Update Posted (Actual)

November 1, 2018

Last Update Submitted That Met QC Criteria

October 4, 2018

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AP-ADF-114

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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