Bupropion as a Smoking Cessation Aid in Alcoholics

This study has been completed.
Sponsor:
Information provided by:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:
NCT00044434
First received: August 28, 2002
Last updated: January 25, 2008
Last verified: January 2008

August 28, 2002
January 25, 2008
May 2002
April 2005   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00044434 on ClinicalTrials.gov Archive Site
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Bupropion as a Smoking Cessation Aid in Alcoholics
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
  • Alcoholism
  • Smoking
Drug: bupropion (Wellbutrin)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
April 2005
April 2005   (final data collection date for primary outcome measure)

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.
Both
25 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00044434
NIAAAGRA13689
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Not Provided
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Not Provided
Not Provided
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP