Abuse Potential of Intranasal VYCAVERT Tablets (Hydrocodone Bitartrate/Acetaminophen) in Recreational Opioid Users
NCT ID: NCT01759446
Last Updated: 2018-11-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
44 participants
INTERVENTIONAL
2013-02-28
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Placebo taken first
Placebo powder snorted with all other arms taken crossover therafter
Placebo taken first
Snorted in both nostrils within 5 minutes; 48 hours washout between doses
Generic H/A taken first
Generic hydrocodone/APAP 10/325mg pulverized tablet snorted with all other arms taken crossover therafter
Generic H/A taken first
Snorted in both nostrils within 5 minutes; 48 hours washout between doses
Vycavert taken first
Vycavert hydrocodone/APAP 10/325mg pulverized tablet snorted with all other arms taken crossover therafter
Vycavert taken first
Snorted in both nostrils within 5 minutes; 48 hours washout between doses
Generic H/A plus i taken first
Generic hydrocodone/APAP 10/325mg plus additional inactive ingredients pulverized tablet snorted with all other arms taken crossover therafter
Generic H/A plus i taken first
Snorted in both nostrils within 5 minutes; 48 hours washout between doses
Generic H/A plus p taken first
Generic hydrocodone/APAP 10/325mg plus one placebo pulverized tablet snorted with all other arms taken crossover therafter
Generic H/A plus p taken first
Snorted in both nostrils within 5 minutes; 48 hours washout between doses
Interventions
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Placebo taken first
Snorted in both nostrils within 5 minutes; 48 hours washout between doses
Generic H/A taken first
Snorted in both nostrils within 5 minutes; 48 hours washout between doses
Vycavert taken first
Snorted in both nostrils within 5 minutes; 48 hours washout between doses
Generic H/A plus i taken first
Snorted in both nostrils within 5 minutes; 48 hours washout between doses
Generic H/A plus p taken first
Snorted in both nostrils within 5 minutes; 48 hours washout between doses
Eligibility Criteria
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Inclusion Criteria
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
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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18 Years
55 Years
ALL
Yes
Sponsors
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Acura Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Lynne Webster, MD
Role: PRINCIPAL_INVESTIGATOR
Lifetree Clinical Research
Locations
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Lifetree Clinical Research
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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AP-ADF-301
Identifier Type: -
Identifier Source: org_study_id
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