To Evaluate the Relative Abuse Potential of Hydrocodone Bitartrate and Acetaminophen
A Randomized, Double-Blind, Double-Dummy, Active- and Placebo-Controlled, 4-Way Crossover Study to Evaluate the Relative Abuse Potential of Hydrocodone Bitartrate and Acetaminophen 6 × 10/325 mg Tablets Compared to NORCO® 6 × 10/325 mg Tablets and Placebo in Non-Dependent, Recreational Opioid Users When Administered Orally Under Fed and Fasted Conditions
1 other identifier
interventional
32
1 country
1
Brief Summary
Evaluation of abuse potential in recreational abusers of Hydrocodone Bitartrate and Acetaminophen versus NORCO®.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Dec 2017
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 29, 2017
CompletedFirst Submitted
Initial submission to the registry
March 20, 2018
CompletedFirst Posted
Study publicly available on registry
June 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2018
CompletedApril 29, 2019
April 1, 2019
10 months
March 20, 2018
April 26, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Drug Liking
Visual analog scale on score from 0 to 100
15 weeks
Study Arms (4)
Placebo
PLACEBO COMPARATORSingle dose
Hydrocodon bitartrate-acetaminophen arm 1
EXPERIMENTALSingle dose
Hydrocodon bitartrate-acetaminophen arm 2
EXPERIMENTALSingle dose
Reference
ACTIVE COMPARATORSingle dose
Interventions
Tablet orally administered under fasting
Tablet orally administered under fasted conditions
Tablet orally administered under fed conditions
Tablet orally administered under fasted conditions
Eligibility Criteria
You may qualify if:
- Healthy male or female subjects 18 to 55 years of age.
- Opioid users who have used opioids for recreational purposes and or is an avid opioid user.
You may not qualify if:
- Substance or alcohol dependence (excluding nicotine and caffeine) within the past 2 years.
- Heavy smoker and/or is unable to abstain from smoking or unable to abstain from the use of prohibited nicotine containing products for at least 6 hours during the in-clinic periods.
- Difficulty swallowing large number of pills.
- Subjects who have had a tattoo or body piercing.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SPARC Site 1
Toronto, Ontario, M5V 2T3, Canada
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2018
First Posted
June 26, 2018
Study Start
December 29, 2017
Primary Completion
October 31, 2018
Study Completion
October 31, 2018
Last Updated
April 29, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share