A Study to Evaluate the Interaction Between Vicodin® CR and Ethanol in Healthy Male and Female Moderate Alcohol Drinkers

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

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Brief Summary

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The purpose of this research study is to determine if varying strengths of ethanol affect the drug level and safety profile of Vicodin® CR.

Detailed Description

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Conditions

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Drug Interactions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Vicodin® CR (extended-release hydrocodone/acetaminophen)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males and females ages 19 to 55
* If female, must be of non-child bearing potential or practicing birth control
* Current alcohol users who are classified as moderate drinkers (defined as 7-21 drinks per week)

Exclusion Criteria

* Intolerance towards ethanol
* Is allergic to or has a serious reaction to hydrocodone, other opioids, or acetaminophen
* Significant GI narrowing or abnormality with a potential to inhibit GI motility or tablet transport
* History of seizures or convulsions, head injury or other intracranial lesions, or a pre-existing increase in intracranial pressure
* Has any clinically significant abnormalities on physical examination, ECG, or laboratory values
* Treatment with any investigational drug within 30 days of administration of study drug in the Treatment Phase

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Rita Jain, MD

Role: STUDY_DIRECTOR

Abbott

Locations

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Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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M06-835

Identifier Type: -

Identifier Source: org_study_id