Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-03-05 @ 7:53 PM
Study NCT ID:
NCT00044434
Status:
COMPLETED
Last Update Posted:
2008-01-29
First Post:
2002-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bupropion as a Smoking Cessation Aid in Alcoholics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016642', 'term': 'Bupropion'}], 'ancestors': [{'id': 'D011427', 'term': 'Propiophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2005-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-01-25', 'studyFirstSubmitDate': '2002-08-28', 'studyFirstSubmitQcDate': '2002-08-29', 'lastUpdatePostDateStruct': {'date': '2008-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-04', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Alcoholism', 'Smoking']}, 'referencesModule': {'references': [{'pmid': '37230961', 'type': 'DERIVED', 'citation': 'Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the use of time-released bupropion (Wellbutrin) in patients receiving treatment for alcohol abuse/dependence as an aid to stop smoking. Patients will receive either a time-released bupropion or placebo. Both groups will receive nicotine replacement therapy during the 9 week study. A final followup assessment will be conducted 6 months from the start of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently a patient in the Omaha VA Medical Center, Substance Abuse Treatment Center (SATC) or at Catholic Charities Campus for Hope.\n* Have a diagnosis of alcohol abuse or alcohol dependence.\n* Smoke 20 or more cigarettes/day (may also smoke pipes/cigars).\n* Be interested in quitting smoking.\n* Provide name, addresses, and phone numbers of at least two individuals who can provide information on their alcohol, nicotine, and other drug use during the follow-up period.\n* If female, patient must a) be of non-childbearing potential, b) have a negative pregnancy test, c) sign a document stating they do not plan on becoming pregnant during the study.\n* Agree to sign informed consent.\n* Able to read and understand study-related forms and procedures.\n\nExclusion Criteria:\n\n* Advanced cardiac, pulmonary, renal, or liver disease.\n* History of seizures.\n* History of brain tumor or significant head trauma.\n* History of bulimia or anorexia nervosa.\n* Current major depressive disorder or past history of panic disorders, schizophrenia, or bipolar affective disorder.\n* Using psychoactive drugs.\n* Receiving treatment with medications that lower seizure thresholds.\n* Use of an investigational drug in any study in the past four weeks.\n* Currently using any asthma medication.\n* Used time-released bupropion in the past 12 months.\n* Currently using any other treatments to stop smoking.'}, 'identificationModule': {'nctId': 'NCT00044434', 'briefTitle': 'Bupropion as a Smoking Cessation Aid in Alcoholics', 'organization': {'class': 'NIH', 'fullName': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)'}, 'officialTitle': 'Bupropion as a Smoking Cessation Aid in Alcoholics', 'orgStudyIdInfo': {'id': 'NIAAAGRA13689'}}, 'armsInterventionsModule': {'interventions': [{'name': 'bupropion (Wellbutrin)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '68105', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'VA/Nebraska/Western Iowa Health Care System', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}}}}