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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00429468

Enrollment

Registered

2007-01-31

Start date

2007-01-31

Completion date

Unknown

Last updated

2007-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Interactions

Brief summary

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

Interventions

DRUGVicodin® CR (extended-release hydrocodone/acetaminophen)

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Standard pharmacokinetic assessments	—
statistical, clinical and laboratory procedures	—

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026