A Study to Evaluate the Interaction Between Vicodin┬« CR and Ethanol in Healthy Male and Female Moderate Alcohol Drinkers
Information source: Abbott
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Drug Interactions
Intervention: Vicodin« CR (extended-release hydrocodone/acetaminophen) (Drug)
Phase: Phase 1
Sponsored by: Abbott
Official(s) and/or principal investigator(s):
Rita Jain, MD, Study Director, Affiliation: Abbott
The purpose of this research study is to determine if varying strengths of ethanol affect the
drug level and safety profile of Vicodin« CR.
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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study
Standard pharmacokinetic assessments
statistical, clinical and laboratory procedures
Minimum age: 19 Years.
Maximum age: 55 Years.
- 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
- Intolerance towards ethanol
- Is allergic to or has a serious reaction to hydrocodone, other opioids, or
- Significant GI narrowing or abnormality with a potential to inhibit GI motility or
- 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
- Treatment with any investigational drug within 30 days of administration of study drug
in the Treatment Phase
Locations and Contacts
Toronto, Ontario M5V 2T3, Canada
Starting date: January 2007
Last updated: October 24, 2007