Bupropion as a Smoking Cessation Aid in Alcoholics

This study has been completed.

First Received on August 28, 2002. Last Updated on January 25, 2008 History of Changes

Sponsor:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:	NCT00044434

Purpose

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.

Condition	Intervention	Phase
Alcoholism Smoking	Drug: bupropion (Wellbutrin)	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Bupropion as a Smoking Cessation Aid in Alcoholics

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism Quitting Smoking Smoking

Drug Information available for: Bupropion hydrochloride Bupropion

U.S. FDA Resources

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Estimated Enrollment:	200
Study Start Date:	May 2002
Study Completion Date:	April 2005
Primary Completion Date:	April 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	25 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044434

Locations

United States, Nebraska
VA/Nebraska/Western Iowa Health Care System
Omaha, Nebraska, United States, 68105

Sponsors and Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00044434 History of Changes
Other Study ID Numbers:	NIAAAGRA13689
Study First Received:	August 28, 2002
Last Updated:	January 25, 2008
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Alcoholism
Smoking
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Habits
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012