Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-29 @ 12:24 AM
Study NCT ID:
NCT00429468
Status:
COMPLETED
Last Update Posted:
2007-10-26
First Post:
2007-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Interaction Between Vicodin® CR and Ethanol in Healthy Male and Female Moderate Alcohol Drinkers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'statusVerifiedDate': '2007-10', 'lastUpdateSubmitDate': '2007-10-24', 'studyFirstSubmitDate': '2007-01-29', 'studyFirstSubmitQcDate': '2007-01-29', 'lastUpdatePostDateStruct': {'date': '2007-10-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Standard pharmacokinetic assessments'}, {'measure': 'statistical, clinical and laboratory procedures'}]}, 'conditionsModule': {'conditions': ['Drug Interactions']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to determine if varying strengths of ethanol affect the drug level and safety profile of Vicodin® CR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females ages 19 to 55\n* If female, must be of non-child bearing potential or practicing birth control\n* Current alcohol users who are classified as moderate drinkers (defined as 7-21 drinks per week)\n\nExclusion Criteria:\n\n* Intolerance towards ethanol\n* Is allergic to or has a serious reaction to hydrocodone, other opioids, or acetaminophen\n* Significant GI narrowing or abnormality with a potential to inhibit GI motility or tablet transport\n* History of seizures or convulsions, head injury or other intracranial lesions, or a pre-existing increase in intracranial pressure\n* Has any clinically significant abnormalities on physical examination, ECG, or laboratory values\n* Treatment with any investigational drug within 30 days of administration of study drug in the Treatment Phase'}, 'identificationModule': {'nctId': 'NCT00429468', 'briefTitle': 'A Study to Evaluate the Interaction Between Vicodin® CR and Ethanol in Healthy Male and Female Moderate Alcohol Drinkers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'M06-835'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Vicodin® CR (extended-release hydrocodone/acetaminophen)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5V 2T3', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Rita Jain, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}}}}