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

Abbott

Status and phase: Completed; Phase 1

Conditions: Drug Interactions

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00429468

M06-835

Details and patient eligibility

About

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

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind