Opioid Abuse
Conditions
Keywords
Abuse Liability, Abuse Prevention, Abuse Resistance, Abuse Deterrence
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.
Interventions
DRUG40/0mg taken first
8x Oxycodone/Niacin 5/0mg tablets All arms taken with a 48 hour washout between doses
DRUG80/0mg taken first
8x Oxycodone/Niacin 10/0mg tablets All arms taken with a 48 hour washout between doses
DRUG40/240mg taken first
8x Oxycodone/Niacin 5/30mg tablets All arms taken with a 48 hour washout between doses
DRUG80/480mg taken first
8x Oxycodone/Niacin 10/60mg tablets All arms taken with a 48 hour washout between doses
DRUG0/0mg taken first
Placebo All arms taken with a 48 hour washout between doses
Sponsors
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Acura Pharmaceuticals Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Matching white tablets
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 40/0mg Taken First oxycodone.naicin 40/0mg tablets | 10 |
| 80/0mg Taken First oxycodone.naicin 80/0mg tablets | 10 |
| 40/240mg Taken First oxycodone.naicin 40/240mg tablets | 9 |
| 80/480mg Taken First oxycodone.naicin 80/480mg tablets | 9 |
| 0/0mg Taken First Placebo Tablets | 9 |
| Total | 47 |
Baseline characteristics
| Characteristic | Total | 80/0mg Taken First | 40/240mg Taken First | 40/0mg Taken First | 80/480mg Taken First | 0/0mg Taken First |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 47 Participants | 10 Participants | 9 Participants | 10 Participants | 9 Participants | 9 Participants |
| Age, Continuous | 23.9 years STANDARD_DEVIATION 4.83 | 23.9 years STANDARD_DEVIATION 4.83 | 23.9 years STANDARD_DEVIATION 4.83 | 23.9 years STANDARD_DEVIATION 4.83 | 23.9 years STANDARD_DEVIATION 4.83 | 23.9 years STANDARD_DEVIATION 4.83 |
| Region of Enrollment United States | 47 participants | 10 participants | 9 participants | 10 participants | 9 participants | 9 participants |
| Sex: Female, Male Female | 12 Participants | 3 Participants | 2 Participants | 3 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 35 Participants | 7 Participants | 7 Participants | 7 Participants | 7 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 49 | 0 / 49 | 0 / 49 | 0 / 49 |
| other Total, other adverse events | 37 / 49 | 46 / 49 | 47 / 49 | 49 / 49 | 3 / 49 |
| serious Total, serious adverse events | 0 / 49 | 0 / 49 | 0 / 49 | 0 / 49 | 0 / 49 |
Outcome results
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).
Time frame: Measure collected at 0.5 hours post-dose
Population: Per protocol completers
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 40/0mg | Drug Liking at .5 Hours | 66.0 score on a scale | Standard Deviation 16.44 |
| 80/0mg | Drug Liking at .5 Hours | 74.7 score on a scale | Standard Deviation 16.86 |
| 40/240mg | Drug Liking at .5 Hours | 47.7 score on a scale | Standard Deviation 19.96 |
| 80/480mg | Drug Liking at .5 Hours | 40.9 score on a scale | Standard Deviation 22.93 |
| 0/0mg | Drug Liking at .5 Hours | 50.3 score on a scale | Standard Deviation 2.28 |