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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03567941

Enrollment

Registered

2018-06-26

Start date

2017-12-29

Completion date

2018-10-31

Last updated

2019-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Interventions

DRUGPlacebo

Tablet orally administered under fasting

DRUGHydrocodon bitartrate-acetaminophen arm 1

Tablet orally administered under fasted conditions

DRUGHydrocodon bitartrate-acetaminophen arm 2

Tablet orally administered under fed conditions

DRUGReference

Tablet orally administered under fasted conditions

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

1. Healthy male or female subjects 18 to 55 years of age. 2. Opioid users who have used opioids for recreational purposes and or is an avid opioid user.

Exclusion criteria

1. Substance or alcohol dependence (excluding nicotine and caffeine) within the past 2 years. 2. 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. 3. Difficulty swallowing large number of pills. 4. Subjects who have had a tattoo or body piercing.

Design outcomes

Primary

Measure	Time frame	Description
Drug Liking	15 weeks	Visual analog scale on score from 0 to 100

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026