Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-30 @ 7:57 AM
Study NCT ID:
NCT00190957
Status:
COMPLETED
Last Update Posted:
2007-11-06
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atomoxetine Treatment of Adults With ADHD and Comorbid Alcohol Abuse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069445', 'term': 'Atomoxetine Hydrochloride'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-11-05', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2007-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To test that atomoxetine is superior to placebo in reducing ADHD severity as measured by the Adult ADHD Investigator Symptom Rating Scale (AISRS) Total score and is superior to placebo in time to relapse of alcohol abuse at 12 weeks.'}], 'secondaryOutcomes': [{'measure': 'Total alcohol consumption (mean drinks/day) during the final week of treatment is lower in patients treated with atomoxetine than in patients receiving placebo.'}, {'measure': 'The proportion of drinking days is smaller for atomoxetine-treated patients compared with those in the placebo group.'}, {'measure': 'Time to relapse of alcohol abuse is longer for atomoxetine-treated patients compared with those in the placebo group.'}, {'measure': 'Number of drinks per drinking day is smaller for patients treated with atomoxetine compared with placebo.'}, {'measure': 'The proportion of substance use days, for substances other than alcohol, is smaller among patients treated with atomoxetine as compared with placebo.'}, {'measure': 'After approximately 12 weeks of treatment, patients who receive atomoxetine will have superior social and occupational functioning compared with those who receive placebo as assessed by changes in the EWPS.'}, {'measure': 'Global functioning as assessed by the CGI-Overall-S and the CGI-I are superior in patients treated with atomoxetine as compared with those treated with placebo.'}, {'measure': 'Improvement in depressive symptoms as assessed by the HAM-D-17.'}, {'measure': 'Improvement in anxiety symptoms as assessed by the HAM-A.'}, {'measure': 'Improvement in self-reported ADHD symptoms as assessed by the ASRS.'}, {'measure': 'Improvement in self-rated symptoms of alcohol cravings as assessed by the OCDS.'}, {'measure': 'Improvement in specific symptoms of ADHD as assessed by the WRAADDS.'}, {'measure': 'Improvement in the self-rated adaptive functioning as assessed by the ASR.'}, {'measure': 'Improvement in the informant-related adaptive functioning as assessed by the ABCL.'}, {'measure': 'Improvement in work, social, and home life functioning as assessed by the Sheehan Disability Scale.'}, {'measure': 'Improvement in general quality of life as assessed by the SF-36 Health Status Survey and the Q-LES-Q-SF.'}]}, 'conditionsModule': {'conditions': ['ADHD', 'Comorbid Alcohol Abuse']}, 'referencesModule': {'references': [{'pmid': '25019647', 'type': 'DERIVED', 'citation': 'Bangs ME, Wietecha LA, Wang S, Buchanan AS, Kelsey DK. Meta-analysis of suicide-related behavior or ideation in child, adolescent, and adult patients treated with atomoxetine. J Child Adolesc Psychopharmacol. 2014 Oct;24(8):426-34. doi: 10.1089/cap.2014.0005. Epub 2014 Jul 14.'}, {'pmid': '22029549', 'type': 'DERIVED', 'citation': "Wilens TE, Adler LA, Tanaka Y, Xiao F, D'Souza DN, Gutkin SW, Upadhyaya HP. Correlates of alcohol use in adults with ADHD and comorbid alcohol use disorders: exploratory analysis of a placebo-controlled trial of atomoxetine. Curr Med Res Opin. 2011 Dec;27(12):2309-20. doi: 10.1185/03007995.2011.628648. Epub 2011 Oct 27."}], 'seeAlsoLinks': [{'url': 'http://www.lillytrials.com', 'label': 'Lilly Clinical Trial Registry'}]}, 'descriptionModule': {'briefSummary': 'Atomoxetine Treatment of Adults with ADHD and Comorbid Alcohol Abuse'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nYou must be at least 18 years old.\n\nYou must have a diagnosis of ADHD and a diagnosis of alcohol abuse or dependence.\n\nYou must have acceptable results on blood and urine tests and an electrocardiogram (ECG).\n\nYour recent drinking history must meet specific requirements.\n\nExclusion Criteria:\n\nYou have taken atomoxetine in the past.\n\nYou have a psychiatric disorder, other than ADHD and alcohol abuse or dependence, for which you will need psychiatric medication.\n\nYou have cognitive impairment (such as memory loss), a brain injury, or a seizure disorder.\n\nYou have a history of severe allergies to more than 1 class of medication or multiple bad reaction to drugs.'}, 'identificationModule': {'nctId': 'NCT00190957', 'briefTitle': 'Atomoxetine Treatment of Adults With ADHD and Comorbid Alcohol Abuse', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Atomoxetine Treatment of Adults With ADHD and Comorbid Alcohol Abuse: A Randomized, Placebo-Controlled Trial', 'orgStudyIdInfo': {'id': '7069'}, 'secondaryIdInfos': [{'id': 'B4Z-MC-LYBY'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Atomoxetine', 'type': 'DRUG'}, {'name': 'placebo', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'El Centro', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 32.792, 'lon': -115.56305}}, {'city': 'Poway', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 32.96282, 'lon': -117.03586}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'New London', 'state': 'Connecticut', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 41.35565, 'lon': -72.09952}}, {'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'city': 'Cambridge', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 42.3751, 'lon': -71.10561}}, {'city': 'Okemos', 'state': 'Michigan', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 42.72226, 'lon': -84.42747}}, {'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'city': 'Moorestown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 39.96706, 'lon': -74.94267}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'city': 'Herndon', 'state': 'Virginia', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 38.96955, 'lon': -77.3861}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Middleton', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 43.09722, 'lon': -89.50429}}, {'city': 'Vancouver', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}}}}