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

Opioid Abuse Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01030406
• Other study ID #: AP-ADF-114
• Status: Completed
• Phase: Phase 2
• Start date: January 2010
• Est. completion date: February 2010

Study information

• Verified date: March 2010
• Source: Acura Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Opioid Abuse

Intervention

Drug:
• 40/0mg taken first
8x Oxycodone/Niacin 5/0mg tablets All arms taken with a 48 hour washout between doses
• 80/0mg taken first
8x Oxycodone/Niacin 10/0mg tablets All arms taken with a 48 hour washout between doses
• 40/240mg taken first
8x Oxycodone/Niacin 5/30mg tablets All arms taken with a 48 hour washout between doses
• 80/480mg taken first
8x Oxycodone/Niacin 10/60mg tablets All arms taken with a 48 hour washout between doses
• 0/0mg taken first
Placebo All arms taken with a 48 hour washout between doses

Locations

Country	Name	City	State
United States	Lifetree Clinical Research	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Acura Pharmaceuticals Inc.	King Pharmaceuticals is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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