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

Condition(s) targeted: Drug Interactions

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

Phase: Phase 1

Status: Completed

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

Primary outcome:

Standard pharmacokinetic assessments

statistical, clinical and laboratory procedures

Minimum age: 19 Years. Maximum age: 55 Years. Gender(s): Both.

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

Toronto, Ontario M5V 2T3, Canada

Starting date: January 2007
Last updated: October 24, 2007