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

Opioid-Related Disorders Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01759446
• Other study ID #: AP-ADF-301
• Status: Completed
• Phase: Phase 2
• Start date: February 2013
• Est. completion date: April 2013

Study information

• Verified date: August 2018
• Source: Acura Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

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).

Related Conditions & MeSH terms

• Opioid-Related Disorders

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Lifetree Clinical Research	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Acura Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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