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

A

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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