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

This study has been completed.

First Received: January 29, 2007 Last Updated: October 24, 2007 History of Changes

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

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

Resource links provided by NLM:

Drug Information available for: Ethanol Acetaminophen CT 2584 Vicodin Hydrocodone

U.S. FDA Resources

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

No publications provided

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

Study placed in the following topic categories:

Analgesics, Non-Narcotic
Oxycodone
Hydrocodone
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents

Analgesics
Healthy
Analgesics, Opioid
Acetaminophen
Ethanol

Additional relevant MeSH terms:

Oxycodone
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents

Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Acetaminophen
Analgesics, Opioid

ClinicalTrials.gov processed this record on July 02, 2009