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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00429468
First Posted: January 31, 2007
Last Update Posted: October 26, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Abbott
  Purpose
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
Intervention Model: Single Group Assignment
Masking: Double
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
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00429468


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

ClinicalTrials.gov Identifier: NCT00429468     History of Changes
Other Study ID Numbers: M06-835
First Submitted: January 29, 2007
First Posted: January 31, 2007
Last Update Posted: October 26, 2007
Last Verified: October 2007

Additional relevant MeSH terms:
Acetaminophen
Acetaminophen, hydrocodone drug combination
Hydrocodone
Oxycodone
Ethanol
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Analgesics, Opioid
Narcotics
Antitussive Agents
Respiratory System Agents
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents