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Trial NCT00000457

Resource URI: http://static.linkedct.org/resource/trials/NCT00000457
PropertyValue
linkedct:brief_title Pharmacologic Relapse Prevention for Alcoholic Smokers
linkedct:condition <http://static.linkedct.org/resource/condition/12227>
linkedct:condition <http://static.linkedct.org/resource/condition/744>
linkedct:criteria Inclusion Criteria: - History of alcohol dependence and at least one year of abstinence from alcohol intake. - Has a history of smoking 20 or more cigarettes per day for the prior year. - Can read and write English. - Stated ability to fully participate in the study and keep all scheduled appointments. - Has provided written informed consent. - General good health. Exclusion Criteria: - Recent history (within three months) of a clinically significant myocardial infarction, unstable angina pectoris, serious cardiac arrhythmia or any other medical condition which the physician investigator deems incompatible with study participation. - Current major depression. A past history of major depression will not be an exclusionary criteria. - Current or previous use of bupropion (Wellbutrin). - Active non- nicotine drug dependence. - Past or current history of bipolar disorder, pain disorder or psychosis, schizophrenia, or other major psychiatric disorders. - Current medically indicated use of psychiatric drugs. - Females who are pregnant, lactating, or likely to become pregnant during the first year which includes the nicotine patch and bupropion (Wellbutrin) phase. - History of severe skin allergies or evidence of severe chronic skin disorders. - Current use of nicotine containing medication or tobacco products other than cigarettes. - Current use (within 30 days of initiation of patch therapy) of the following medications for smoking cessation: clonidine, buspirone, or doxepin. - A predisposition to seizures. - A history of or current diagnosis of anorexia nervosa or bulimia. - Medical disorder that would interfere with the absorption, metabolism, or excretion of bupropion (Wellbutrin).
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date August 2001
linkedct:enrollment 292 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000457
rdfs:label Trial NCT00000457
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Institute on Alcohol Abuse and Alcoholism (NIAAA)
linkedct:location <http://static.linkedct.org/resource/location/190552>
linkedct:nct_id NCT00000457
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Pharmacologic Relapse Prevention for Alcoholic Smokers
linkedct:org_study_id NIAAAHUR11219
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000457>
linkedct:phase Phase 2
linkedct:source National Institute on Alcohol Abuse and Alcoholism (NIAAA)
linkedct:study_design Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
linkedct:study_type Interventional
linkedct:summary This study will compare the long-term use of bupropion (Wellbutrin) and placebo for reducing the rate of smoking relapse in recovering alcoholics who achieved initial abstinence from smoking with nicotine patch therapy. The study will also determine the cessation rate in the 8th week of treatment among recovering alcoholics using a nicotine patch. The patch dose is projected to serve as a 100-percent replacement.
rdf:type linkedct:trials
linkedct:verification_date August 2002