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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: January 29, 2007
Last updated: October 24, 2007
Last verified: October 2007

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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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:

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

Ages Eligible for Study:   19 Years to 55 Years
Genders Eligible for Study:   Both
Accepts 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00429468

Canada, Ontario
Toronto, Ontario, Canada, M5V 2T3
Sponsors and Collaborators
Study Director: Rita Jain, MD Abbott
  More Information

No publications provided

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

Additional relevant MeSH terms:
Acetaminophen, hydrocodone drug combination
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 14, 2014