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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Opioid Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Matching white tablets

Study Groups

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40/0mg taken first

8x oxycodone/niacin 5/0mg tablets

Group Type ACTIVE_COMPARATOR

40/0mg taken first

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

80/0mg taken first

Intervention Type DRUG

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

Group Type EXPERIMENTAL

40/240mg taken first

Intervention Type DRUG

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

Group Type EXPERIMENTAL

80/480mg taken first

Intervention Type DRUG

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

0/0mg taken first

Placebo

Group Type PLACEBO_COMPARATOR

0/0mg taken first

Intervention Type DRUG

Placebo All arms taken with a 48 hour washout between doses

Interventions

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40/0mg taken first

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

Intervention Type DRUG

80/0mg taken first

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

Intervention Type DRUG

40/240mg taken first

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

Intervention Type DRUG

80/480mg taken first

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

Intervention Type DRUG

0/0mg taken first

Placebo All arms taken with a 48 hour washout between doses

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes