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

This study has been completed.
Sponsor:
Collaborator:
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Information provided by:
Acura Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01030406
First received: December 10, 2009
Last updated: March 8, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Opioid Abuse
Drug: Drug A
Drug: Drug B
Drug: Drug C
Drug: Drug D
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by Acura Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Drug Liking/Disliking analyzed over 0-3 hours [ Time Frame: collected at 0.5,1,1.5, 2,3,4,5,6,8, and 12 hours post-dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Take Drug Again Assessment (TDAA) [ Time Frame: 1, 2, and 8 hours post-dose ] [ Designated as safety issue: Yes ]
  • Global Assessment of Overall Drug Liking [ Time Frame: 12 hours post-dose ] [ Designated as safety issue: Yes ]
  • Pupillometry [ Time Frame: pre-dose and 0.5,1,1.5,2,3,4,5,6,8, and 12 hours post-dose ] [ Designated as safety issue: Yes ]

Enrollment: 47
Study Start Date: January 2010
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment A Drug: Drug A
Tablets
Active Comparator: Treatment B Drug: Drug B
Tablets
Experimental: Treatment C Drug: Drug C
Tablets
Experimental: Treatment D Drug: Drug D
Tablets
Placebo Comparator: Treatment E Drug: Placebo
Tablets

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01030406

Locations
United States, Utah
Lifetree Clinical Research
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
Acura Pharmaceuticals Inc.
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Andy Reddick, CEO, Acura Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01030406     History of Changes
Other Study ID Numbers: AP-ADF-114
Study First Received: December 10, 2009
Last Updated: March 8, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Acura Pharmaceuticals Inc.:
Abuse Liability
Abuse Prevention
Abuse Resistance
Abuse Deterrence

Additional relevant MeSH terms:
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 01, 2014