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

Tracking Information

First Received Date ^ICMJE

January 29, 2007

Last Updated Date

October 24, 2007

Start Date ^ICMJE

January 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Standard pharmacokinetic assessments
statistical, clinical and laboratory procedures

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00429468 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Single-Centre, Double-Blind, Randomized, Placebo-Controlled, Phase 1 Study to Evaluate the Interaction Between Vicodin® CR and Ethanol in Healthy Male and Female Moderate Alcohol Drinkers

Brief Summary

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

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study

Condition ^ICMJE

Drug Interactions

Intervention ^ICMJE

Drug: Vicodin® CR (extended-release hydrocodone/acetaminophen)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

19 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00429468

Responsible Party

Study ID Numbers ^ICMJE

M06-835

Study Sponsor ^ICMJE

Abbott

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Rita Jain, MD

Abbott

Information Provided By

Abbott

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP