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

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

This study has been completed.

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00429468

Purpose

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

Condition	Intervention	Phase
Drug Interactions	Drug: Vicodin® CR (extended-release hydrocodone/acetaminophen)	Phase I

Drug Information available for:

Acetaminophen Ethanol Hydrocodone Hydrocodone bitartrate Vicodin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study

Official Title:	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

Further study details as provided by Abbott:

Primary Outcome Measures:

Standard pharmacokinetic assessments
statistical, clinical and laboratory procedures

Estimated Enrollment:	25
Study Start Date:	January 2007

Eligibility

Ages Eligible for Study:	19 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429468

Locations


Canada, Ontario

	Toronto, Ontario, Canada, M5V 2T3

Sponsors and Collaborators

Abbott

Investigators


Study Director:	Rita Jain, MD	Abbott

More Information

Study ID Numbers:	M06-835
First Received:	January 29, 2007
Last Updated:	October 24, 2007
ClinicalTrials.gov Identifier:	NCT00429468
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Hydrocodone

Healthy

Acetaminophen

Ethanol

Additional relevant MeSH terms:

Sensory System Agents

Analgesics, Non-Narcotic

Therapeutic Uses

Physiological Effects of Drugs

Peripheral Nervous System Agents

Analgesics

Central Nervous System Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008