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

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.

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.

Study Overview

• Status: Completed
• Conditions: Opioid-Related Disorders
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Lifetree Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Acura Pharmaceuticals Inc.
• Investigators: Principal Investigator: Lynne Webster, MD, Lifetree Clinical Research

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: December 18, 2012
• First Submitted That Met QC Criteria: December 31, 2012
• First Posted (Estimate): January 3, 2013

Study Record Updates

• Last Update Posted (Actual): November 1, 2018
• Last Update Submitted That Met QC Criteria: October 2, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: AP-ADF-301