Abuse Potential of Intranasal VYCAVERT Tablets (Hydrocodone Bitartrate/Acetaminophen) in Recreational Opioid Users
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Intervention: Placebo taken first; Generic H/A taken first; Vycavert taken first; Generic H/A plus i taken first; Generic H/A plus p taken first
Intervention description: Snorted in both nostrils within 5 minutes; 48 hours washout between doses; Snorted in both nostrils within 5 minutes; 48 hours washout between doses; Snorted in both nostrils within 5 minutes; 48 hours washout between doses; Snorted in both nostrils within 5 minutes; 48 hours washout between doses; Snorted in both nostrils within 5 minutes; 48 hours washout between doses
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 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.

          2. 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).

          3. Subjects must have experience with intranasal opioid administration, defined as
             intranasal use on at least 3 occasions within the last year before Screening.

          4. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

          5. 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.

          6. An informed consent document signed and dated by the subject.

          7. Subjects who are willing and able to comply with scheduled visits, treatment plan,
             laboratory tests, and other study procedures.

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        Exclusion Criteria:

          1. Diagnosis of substance and/or alcohol dependence (excluding caffeine and nicotine), as
             assessed by the Investigator using the DSM IV TR criteria.

          2. Has participated in, is currently participating in, or is seeking treatment for
             substance and/or alcohol related disorders (excluding nicotine and caffeine).

          3. 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.

          4. Has a positive alcohol breath test at Screening. Positive results may be repeated
             and/or subjects re scheduled at the Investigator's discretion.

          5. 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).

          6. 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).

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