Pharmacologic Relapse Prevention for Alcoholic Smokers - Tabular View

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00000457 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Pharmacologic Relapse Prevention for Alcoholic Smokers
Official Title ^ICMJE	Pharmacologic Relapse Prevention for Alcoholic Smokers
Brief 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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Condition ^ICMJE	Alcoholism Smoking
Intervention ^ICMJE	Drug: nicotine replacement patch Drug: bupropion (Wellbutrin)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	292
Completion Date	August 2001
Primary Completion Date
Eligibility Criteria ^ICMJE	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).
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00000457
Responsible Party
Study ID Numbers ^ICMJE	NIAAAHUR11219
Study Sponsor ^ICMJE	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Verification Date	August 2002
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP