Opioid Abuse
Conditions
Keywords
Abuse Liability, Abuse Prevention, Abuse Resistance, Abuse Deterrence
Brief summary
The purpose of this study is to assess the abuse liability of 4 times (8 tablets) the usual recommended dose of Acurox (oxycodone HCl 40 mg plus niacin 240 mg) versus oxycodone HCL 40 mg alone in subjects with a history of opioid abuse.
Detailed description
In the Treatment Phase, subjects randomly received oxycodone HCl 40 mg administered in combination with niacin 240 mg and oxycodone HCl 40 mg alone in crossover design. 15 subjects were randomized to receive oxycodone/niacin first followed by oxycodone with a 48 hour washout between doses. 15 subjects randomized to receive oxycodone before the oxycodone/naicin dose with a 48 hour washout between doses. The purpose of the Treatment Phase was to assess the abuse liability and abuse deterrence potential of 4 times the recommended 2-tablet dose of Acurox® Tablets 5/30 mg versus oxycodone HCl 40 mg alone (8 tablets per dose). All 30 subjects received a single dose of each study treatment. Subjects were fasted prior to dosing on all dose days.
Interventions
DRUGAcurox 5/30mg taken first
followed by oxycodone 5mg with 48 hour washout
followed by Acurox 5/30mg with 48 hour washout
Sponsors
Acura Pharmaceuticals Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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 of age * Subject meets DSM-IV Criteria for the Diagnosis of Opioid Substance Abuse and subject is unlikely to experience an idiosyncratic reaction or respiratory depression after ingesting 40 mg of oxycodone * Body weight is not more than 20% above or below ideal body weight * Subject agrees to abstain from any Rx or OTC drugs (except as authorized by the Investigator) or alcohol * Subject is in generally good health * Subject is reliable, willing, cooperative, able to communicate effectively, and has a minimum of a 6th grade reading level * Subject has an acceptable score on the MMSE for cognitive impairment * For women of child-bearing potential: woman is not pregnant and not nursing, and is practicing an acceptable method of birth control
Exclusion criteria
* Subject has a disease that may endanger the subject or the validity of the data * Subject is currently physically dependent on opiates or alcohol * Subject was exposed to any investigational drug within 30 days prior to the inpatient phase * Subject has a history of hypersensitivity to any drug, or a known allergy to any component of the study drug formulation * Subject has a positive urine drug screen for a non-opiate drug * Subject has a predisposing condition that may place the subject at risk for receiving niacin or oxycodone, or confound the study analyses * Subject ingested niacin at doses higher than SDI within 14 days prior to the inpatient phase * Subject has an abnormal bleeding tendency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drug Like/Dislike Effect at 30 Minutes Post Dose (E 30 Min) | Effects assessed at 0.5 hours after dosing. | Do you dislike or like the drug effect you are feeling now? This question was rated on a 1 to 29 point VAS scale that was anchored in the center with neither like nor dislike (14), on the left with dislike an awful lot (1), and on the right with like an awful lot (29). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Acurox 5/30mg Taken First Oxycodone HCL/Niacin 5/30mg; 8 tablet dose followed by Oxycodone 5mg with 48 hour washout | 15 |
| Oxycodone 5mg Taken First Oxycodone HCL 5mg; 8 tablet dose followed by Acurox 5/30mg with 48 hour washout | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Oxycodone 5mg Taken First | Acurox 5/30mg Taken First | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 15 Participants | 30 Participants |
| Age, Continuous | 44.7 years STANDARD_DEVIATION 5.5 | 44.7 years STANDARD_DEVIATION 5.5 | 44.7 years STANDARD_DEVIATION 5.5 |
| Region of Enrollment United States | 15 participants | 15 participants | 39 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 13 Participants | 13 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 28 / 30 | 29 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Drug Like/Dislike Effect at 30 Minutes Post Dose (E 30 Min)
Do you dislike or like the drug effect you are feeling now? This question was rated on a 1 to 29 point VAS scale that was anchored in the center with neither like nor dislike (14), on the left with dislike an awful lot (1), and on the right with like an awful lot (29).
Time frame: Effects assessed at 0.5 hours after dosing.
Population: Study completers and per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acurox 5/30mg | Drug Like/Dislike Effect at 30 Minutes Post Dose (E 30 Min) | 11.7 score on a scale | Standard Error 1 |
| Oxycodone 5mg | Drug Like/Dislike Effect at 30 Minutes Post Dose (E 30 Min) | 14.7 score on a scale | Standard Error 1 |