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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acura Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01759446
First received: December 18, 2012
Last updated: April 7, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Opioid-Related Disorders
Drug: Hydrocodone/Acetaminophen
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Acura Pharmaceuticals Inc.:

Primary Outcome Measures:
  • The primary endpoint analysis will evaluate pharmacodynamics parameters [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Pharmacodynamic parameters i.e., Drug Liking, Drug High, Nasopharyngeal/Facial Effects Scales, Take Drug Again and Overall Drug Liking, and pupillometry comparing Treatment B (GENERIC H/A) to C (VYCAVERT)


Enrollment: 40
Study Start Date: February 2013
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
Drug: Hydrocodone/Acetaminophen
Active Comparator: Hydrocodone and Acetaminophen
Hydrocodone and Acetaminophen
Drug: Hydrocodone/Acetaminophen
Active Comparator: Vycavert (hydrocodone and acetaminophen)
hydrocodone and acetaminophen
Drug: Hydrocodone/Acetaminophen
Active Comparator: Hydrocodone/Acetaminophen with inactives
Hydrocodone/Acetaminophen with inactives
Drug: Hydrocodone/Acetaminophen
Active Comparator: Hydrocodone/Acetaminophen plus placebo
Hydrocodone/Acetaminophen plus placebo
Drug: Hydrocodone/Acetaminophen

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).

    -

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01759446

Locations
United States, Utah
Lifetree Clinical Research
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
Acura Pharmaceuticals Inc.
  More Information

No publications provided

Responsible Party: Acura Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01759446     History of Changes
Other Study ID Numbers: AP-ADF-301
Study First Received: December 18, 2012
Last Updated: April 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Acetaminophen
Acetaminophen, hydrocodone drug combination
Hydrocodone
Oxycodone
Analgesics, Opioid
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 29, 2014