To Evaluate the Relative Abuse Potential of Hydrocodone Bitartrate and Acetaminophen

Study Overview
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Brief Summary
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Evaluation of abuse potential in recreational abusers of Hydrocodone Bitartrate and Acetaminophen versus NORCO®.

Official Title
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A Randomized, Double-Blind, Double-Dummy, Active- and Placebo-Controlled, 4-Way Crossover Study to Evaluate the Relative Abuse Potential of Hydrocodone Bitartrate and Acetaminophen 6 × 10/325 mg Tablets Compared to NORCO® 6 × 10/325 mg Tablets and Placebo in Non-Dependent, Recreational Opioid Users When Administered Orally Under Fed and Fasted Conditions

Conditions
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Healthy

Intervention / Treatment
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* Drug: Placebo
* Drug: Hydrocodon bitartrate-acetaminophen arm 1
* Drug: Hydrocodon bitartrate-acetaminophen arm 2
* Drug: Reference


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or female subjects 18 to 55 years of age. Opioid users who have used opioids for recreational purposes and or is an avid opioid user. Exclusion Criteria: Substance or alcohol dependence (excluding nicotine and caffeine) within the past 2 years. Heavy smoker and/or is unable to abstain from smoking or unable to abstain from the use of prohibited nicotine containing products for at least 6 hours during the in-clinic periods. Difficulty swallowing large number of pills. Subjects who have had a tattoo or body piercing.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Single dose | Drug: Placebo<br>* Tablet orally administered under fasting<br>Drug: Hydrocodon bitartrate-acetaminophen arm 1<br>* Tablet orally administered under fasted conditions<br>Drug: Hydrocodon bitartrate-acetaminophen arm 2<br>* Tablet orally administered under fed conditions<br>Drug: Reference<br>* Tablet orally administered under fasted conditions<br>|
| Experimental: Hydrocodon bitartrate-acetaminophen arm 1<br>Single dose | Drug: Placebo<br>* Tablet orally administered under fasting<br>Drug: Hydrocodon bitartrate-acetaminophen arm 1<br>* Tablet orally administered under fasted conditions<br>Drug: Hydrocodon bitartrate-acetaminophen arm 2<br>* Tablet orally administered under fed conditions<br>Drug: Reference<br>* Tablet orally administered under fasted conditions<br>|
| Experimental: Hydrocodon bitartrate-acetaminophen arm 2<br>Single dose | Drug: Placebo<br>* Tablet orally administered under fasting<br>Drug: Hydrocodon bitartrate-acetaminophen arm 1<br>* Tablet orally administered under fasted conditions<br>Drug: Hydrocodon bitartrate-acetaminophen arm 2<br>* Tablet orally administered under fed conditions<br>Drug: Reference<br>* Tablet orally administered under fasted conditions<br>|
| Active Comparator: Reference<br>Single dose | Drug: Placebo<br>* Tablet orally administered under fasting<br>Drug: Hydrocodon bitartrate-acetaminophen arm 1<br>* Tablet orally administered under fasted conditions<br>Drug: Hydrocodon bitartrate-acetaminophen arm 2<br>* Tablet orally administered under fed conditions<br>Drug: Reference<br>* Tablet orally administered under fasted conditions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug Liking | Visual analog scale on score from 0 to 100 | 15 weeks |