Bupropion as a Smoking Cessation Aid in Alcoholics

Phase 4

Completed

• Conditions: Alcoholism; Smoking

• Registration Number: NCT00044434
• Lead Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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 available

Study Timeline

• Study Start: 2002-05
• Study First Submitted: 2002-08-28
• Study First Submitted QC: 2002-08-29
• Study First Posted: 2002-08-30
• Primary Completion: 2005-04
• Study Completion: 2005-04
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-25
• Last Update Posted: 2008-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

VA/Nebraska/Western Iowa Health Care System; 🇺🇸 Omaha, Nebraska, United States