To Evaluate the Relative Abuse Potential of Hydrocodone Bitartrate and Acetaminophen

Phase 1CompletedNCT03567941

Sun Pharma Advanced Research Company Limited32 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Healthy

Interventions

PlaceboDRUG

Tablet orally administered under fasting

Hydrocodon bitartrate-acetaminophen arm 1DRUG

Tablet orally administered under fasted conditions

Hydrocodon bitartrate-acetaminophen arm 2DRUG

Tablet orally administered under fed conditions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

SPARC Site 1

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Drug Liking

Visual analog scale on score from 0 to 100

Time frame: 15 weeks

Data from ClinicalTrials.gov

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