Bupropion as a Smoking Cessation Aid in Alcoholics

January 25, 2008 updated by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Primary Completion (Actual)

April 1, 2005

Study Completion (Actual)

April 1, 2005

Study Registration Dates

First Submitted

August 28, 2002

First Submitted That Met QC Criteria

August 29, 2002

First Posted (Estimate)

August 30, 2002

Study Record Updates

Last Update Posted (Estimate)

January 29, 2008

Last Update Submitted That Met QC Criteria

January 25, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIAAAGRA13689

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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