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

Phase 2

Completed

• Conditions: Opioid Abuse
• Interventions: Drug: 80/480mg taken first; Drug: 40/0mg taken first; Drug: 80/0mg taken first; Drug: 40/240mg taken first; Drug: 0/0mg taken first

• Registration Number: NCT01030406
• Lead Sponsor: Acura Pharmaceuticals Inc.

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.

Study Timeline

• Study First Submitted: 2009-12-10
• Study First Submitted QC: 2009-12-10
• Study First Posted: 2009-12-11
• Study Start: 2010-01
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2010-03
• Results First Submitted: 2018-06-27
• Results First Submitted QC: 2018-10-04
• Last Update Submitted: 2018-10-04
• Results First Posted: 2018-11-01
• Last Update Posted: 2018-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
80/480mg taken first	80/480mg taken first	8x oxycodone/niacin 10/60mg tablets
40/0mg taken first	40/0mg taken first	8x oxycodone/niacin 5/0mg tablets
80/0mg taken first	80/0mg taken first	8x oxycodone/niacin 10/0mg tablets
40/240mg taken first	40/240mg taken first	8x oxycodone/niacin 5/30mg tablets
0/0mg taken first	0/0mg taken first	Placebo

Primary Outcome Measures

Name	Time	Method
Drug Liking at .5 Hours	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).

Trial Locations

Locations (1)

Lifetree Clinical Research; 🇺🇸 Salt Lake City, Utah, United States