Bupropion as a Smoking Cessation Aid in Alcoholics

This study has been completed.

Sponsor:

Information provided by:

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

ClinicalTrials.gov Identifier:

NCT00044434

First received: August 28, 2002

Last updated: January 25, 2008

Last verified: January 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	August 28, 2002
Last Updated Date	January 25, 2008
Start Date ^ICMJE	May 2002
Primary Completion Date	April 2005 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00044434 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Bupropion as a Smoking Cessation Aid in Alcoholics
Official Title ^ICMJE	Bupropion as a Smoking Cessation Aid in Alcoholics
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Alcoholism Smoking
Intervention ^ICMJE	Drug: bupropion (Wellbutrin)
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	200
Completion Date	April 2005
Primary Completion Date	April 2005 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Currently a patient in the Omaha VA Medical Center, Substance Abuse Treatment Center (SATC) or at Catholic Charities Campus for Hope. Have a diagnosis of alcohol abuse or alcohol dependence. Smoke 20 or more cigarettes/day (may also smoke pipes/cigars). Be interested in quitting smoking. 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. 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. Agree to sign informed consent. Able to read and understand study-related forms and procedures. Exclusion Criteria: Advanced cardiac, pulmonary, renal, or liver disease. History of seizures. History of brain tumor or significant head trauma. History of bulimia or anorexia nervosa. Current major depressive disorder or past history of panic disorders, schizophrenia, or bipolar affective disorder. Using psychoactive drugs. Receiving treatment with medications that lower seizure thresholds. Use of an investigational drug in any study in the past four weeks. Currently using any asthma medication. Used time-released bupropion in the past 12 months. Currently using any other treatments to stop smoking.
Gender	Both
Ages	25 Years to 75 Years
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 Number ^ICMJE	NCT00044434
Other Study ID Numbers ^ICMJE	NIAAAGRA13689
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Verification Date	January 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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