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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Analgesics, Non-Narcotic
Analgesics, Opioid
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents

ClinicalTrials.gov processed this record on May 24, 2016