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OpenTrials
Completed

NCT Number: NCT03567941

To Evaluate the Relative Abuse Potential of Hydrocodone Bitartrate and Acetaminophen

Evaluation of abuse potential in recreational abusers of Hydrocodone Bitartrate and Acetaminophen versus NORCO®.

Completed

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

SPARC Site 1

Toronto, Ontario, M5V 2T3, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Placebo

Drug

Tablet orally administered under fasting

Hydrocodon bitartrate-acetaminophen arm 1

Drug

Tablet orally administered under fasted conditions

Hydrocodon bitartrate-acetaminophen arm 2

Drug

Tablet orally administered under fed conditions

reference

Drug

Tablet orally administered under fasted conditions

Primary outcomes

  1. Drug Liking

    Time frame: 15 weeks

    Visual analog scale on score from 0 to 100

Sponsors and collaborators

Lead sponsor

Sun Pharma Advanced Research Company Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 26, 2018
Registry last updated
Apr 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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