Abuse Potential of Intranasal VYCAVERT Tablets (Hydrocodone Bitartrate/Acetaminophen) in Recreational Opioid Users

Study Overview
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Brief Summary
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To determine the relative abuse potential of VYCAVERT (hydrocodone bitartrate and acetaminophen) compared to GENERIC H/A (hydrocodone bitartrate and acetaminophen) when crushed and administered intranasally to non dependent, recreational opioid users.

Official Title
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A Single-center, Randomized, Double-blind, Active- and Placebo Controlled, 5-way Crossover Study Assessing the Abuse Potential of Intranasally Administered VYCAVERT Tablets in Non-dependent Recreational Opioid Users.

Conditions
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Opioid-Related Disorders

Intervention / Treatment
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* Drug: Placebo taken first
* Drug: Generic H/A taken first
* Drug: Vycavert taken first
* Drug: Generic H/A plus i taken first
* Drug: Generic H/A plus p taken first


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests. Subject is a recreational opioid user who is NOT dependent on opioids based on Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Text Revision (DSM IV TR) criteria. A recreational opioid user is defined as a user of opioids for non medical purposes (i.e., for psychoactive effects) on at least 10 occasions within the last year and at least once in the 12 weeks before the Screening Visit (Visit 1). Subjects must have experience with intranasal opioid administration, defined as intranasal use on at least 3 occasions within the last year before Screening. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs). Subject is able to speak, read, and understand English sufficiently to comprehend the nature of the study and to understand the informed consent form (ICF) and consent process. An informed consent document signed and dated by the subject. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. - Exclusion Criteria: Diagnosis of substance and/or alcohol dependence (excluding caffeine and nicotine), as assessed by the Investigator using the DSM IV TR criteria. Has participated in, is currently participating in, or is seeking treatment for substance and/or alcohol related disorders (excluding nicotine and caffeine). Has a positive urine drug screen (UDS) including tetrahydrocannabinol (THC) at Screening (Visit 1). NOTE: Subjects with an opioid positive or THC-positive UDS at Visit 1 may be re tested once on or before Visit 2 (Day 0). If the UDS re test is negative, the subject can proceed to Visit 2. A positive UDS at Visit 2 will exclude the subject from further participation, unless the UDS is THC-positive in which the subject can continue in the study at the discretion of the Investigator. Has a positive alcohol breath test at Screening. Positive results may be repeated and/or subjects re scheduled at the Investigator's discretion. Has any condition in which an opioid is contraindicated (e.g., significant respiratory depression, acute or severe bronchial asthma or hypercarbia, suspected of having paralytic ileus). Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). -

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo taken first<br>Placebo powder snorted with all other arms taken crossover therafter | Drug: Placebo taken first<br>* Snorted in both nostrils within 5 minutes; 48 hours washout between doses<br>|
| Active Comparator: Generic H/A taken first<br>Generic hydrocodone/APAP 10/325mg pulverized tablet snorted with all other arms taken crossover therafter | Drug: Generic H/A taken first<br>* Snorted in both nostrils within 5 minutes; 48 hours washout between doses<br>|
| Active Comparator: Vycavert taken first<br>Vycavert hydrocodone/APAP 10/325mg pulverized tablet snorted with all other arms taken crossover therafter | Drug: Vycavert taken first<br>* Snorted in both nostrils within 5 minutes; 48 hours washout between doses<br>|
| Active Comparator: Generic H/A plus i taken first<br>Generic hydrocodone/APAP 10/325mg plus additional inactive ingredients pulverized tablet snorted with all other arms taken crossover therafter | Drug: Generic H/A plus i taken first<br>* Snorted in both nostrils within 5 minutes; 48 hours washout between doses<br>|
| Active Comparator: Generic H/A plus p taken first<br>Generic hydrocodone/APAP 10/325mg plus one placebo pulverized tablet snorted with all other arms taken crossover therafter | Drug: Generic H/A plus p taken first<br>* Snorted in both nostrils within 5 minutes; 48 hours washout between doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emax - Maximum Drug Liking | Do you dislike or like the drug effect you are feeling now? The question is scored using a 100-point bipolar visual analog scale (VAS) anchored in the center with neither like nor dislike (score of 50), on the left with Strong Disliking (score of 0) and on the right with Strong Liking (score of 100). Maximum Score. Assessment were made at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 hours post-dosing. | 8 hours |