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

NCT01030406 | Completed Phase 2 Results

• 1 other identifier: AP-ADF-114
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Abuse

Keywords

Abuse Liability; Abuse Prevention; Abuse Resistance; Abuse Deterrence

Outcome Measures

Primary Outcomes (1)

• 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).

  Measure collected at 0.5 hours post-dose

Study Arms (5)

40/0mg taken first

ACTIVE COMPARATOR

8x oxycodone/niacin 5/0mg tablets

Drug: 40/0mg taken first

80/0mg taken first

ACTIVE COMPARATOR

8x oxycodone/niacin 10/0mg tablets

Drug: 80/0mg taken first

40/240mg taken first

EXPERIMENTAL

8x oxycodone/niacin 5/30mg tablets

Drug: 40/240mg taken first

80/480mg taken first

EXPERIMENTAL

8x oxycodone/niacin 10/60mg tablets

Drug: 80/480mg taken first

0/0mg taken first

PLACEBO COMPARATOR

Placebo

Drug: 0/0mg taken first

Interventions

40/0mg taken first DRUG

8x Oxycodone/Niacin 5/0mg tablets All arms taken with a 48 hour washout between doses

40/0mg taken first

80/0mg taken first DRUG

8x Oxycodone/Niacin 10/0mg tablets All arms taken with a 48 hour washout between doses

80/0mg taken first

40/240mg taken first DRUG

8x Oxycodone/Niacin 5/30mg tablets All arms taken with a 48 hour washout between doses

40/240mg taken first

80/480mg taken first DRUG

8x Oxycodone/Niacin 10/60mg tablets All arms taken with a 48 hour washout between doses

80/480mg taken first

0/0mg taken first DRUG

Placebo All arms taken with a 48 hour washout between doses

0/0mg taken first

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Acura Pharmaceuticals Inc.: lead
• King Pharmaceuticals is now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (1)

Lifetree Clinical Research

Salt Lake City, Utah, 84106, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Ron Spivey
• Organization: Acura Pharma

rspivey@acurapharm.com

847-705-7709

Study Officials

• Lynne Webster, MD

  Lifetree Clinical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Matching white tablets
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2009
• First Posted: December 11, 2009
• Study Start: January 1, 2010
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: November 1, 2018
• Results First Posted: November 1, 2018

Record last verified: 2010-03

Locations

US (1)