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

Acura Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Opioid Abuse

Treatments: Drug: 0/0mg taken first; Drug: 80/0mg taken first; Drug: 40/240mg taken first; Drug: 80/480mg taken first; Drug: 40/0mg taken first

Study type: Interventional

Funder types: Industry

Identifiers

NCT01030406

AP-ADF-114

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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49 participants in 5 patient groups, including a placebo group

40/0mg taken first

Active Comparator group

Description:

8x oxycodone/niacin 5/0mg tablets

Treatment:

Drug: 40/0mg taken first

80/0mg taken first

Active Comparator group

Description:

8x oxycodone/niacin 10/0mg tablets

Treatment:

Drug: 80/0mg taken first

40/240mg taken first

Experimental group

Description:

8x oxycodone/niacin 5/30mg tablets

Treatment:

Drug: 40/240mg taken first

80/480mg taken first

Experimental group

Description:

8x oxycodone/niacin 10/60mg tablets

Treatment:

Drug: 80/480mg taken first

0/0mg taken first

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: 0/0mg taken first