Official Title: “Bupropion as a Smoking Cessation Aid in Alcoholics”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study

Study Primary Completion Date: April 2005

Intervention(s) in this Clinical Trial

• Drug: bupropion (Wellbutrin)

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 25 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00044434

Study ID Number: NIAAAGRA13689

ClinicalTrials.gov Identifier: NCT00044434

Health Authority: United States: Federal Government