Bupropion as a Smoking Cessation Aid in Alcoholics - Full Text View

Sponsored by:	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

MedlinePlus related topics: Alcoholism Quitting Smoking Smoking

Drug Information available for: Bupropion hydrochloride Bupropion

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Official Title:	Bupropion as a Smoking Cessation Aid in Alcoholics

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

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

Study placed in the following topic categories:

Smoking
Dopamine
Mental Disorders
Bupropion

Alcoholism
Substance-Related Disorders
Disorders of Environmental Origin
Alcohol-Related Disorders

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Pharmacologic Actions

Habits
Therapeutic Uses
Dopamine Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009