To Evaluate the Relative Abuse Potential of Hydrocodone Bitartrate and Acetaminophen

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-29

Study Completion Date

2018-10-31

Brief Summary

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo

Single dose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablet orally administered under fasting

Hydrocodon bitartrate-acetaminophen arm 1

Intervention Type DRUG

Tablet orally administered under fasted conditions

Hydrocodon bitartrate-acetaminophen arm 2

Intervention Type DRUG

Tablet orally administered under fed conditions

Reference

Intervention Type DRUG

Tablet orally administered under fasted conditions

Hydrocodon bitartrate-acetaminophen arm 1

Single dose

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Tablet orally administered under fasting

Hydrocodon bitartrate-acetaminophen arm 1

Intervention Type DRUG

Tablet orally administered under fasted conditions

Hydrocodon bitartrate-acetaminophen arm 2

Intervention Type DRUG

Tablet orally administered under fed conditions

Reference

Intervention Type DRUG

Tablet orally administered under fasted conditions

Hydrocodon bitartrate-acetaminophen arm 2

Single dose

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Tablet orally administered under fasting

Hydrocodon bitartrate-acetaminophen arm 1

Intervention Type DRUG

Tablet orally administered under fasted conditions

Hydrocodon bitartrate-acetaminophen arm 2

Intervention Type DRUG

Tablet orally administered under fed conditions

Reference

Intervention Type DRUG

Tablet orally administered under fasted conditions

Reference

Single dose

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Tablet orally administered under fasting

Hydrocodon bitartrate-acetaminophen arm 1

Intervention Type DRUG

Tablet orally administered under fasted conditions

Hydrocodon bitartrate-acetaminophen arm 2

Intervention Type DRUG

Tablet orally administered under fed conditions

Reference

Intervention Type DRUG

Tablet orally administered under fasted conditions

Interventions

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Placebo

Tablet orally administered under fasting

Intervention Type DRUG

Hydrocodon bitartrate-acetaminophen arm 1

Tablet orally administered under fasted conditions

Intervention Type DRUG

Hydrocodon bitartrate-acetaminophen arm 2

Tablet orally administered under fed conditions

Intervention Type DRUG

Reference

Tablet orally administered under fasted conditions

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes