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Bupropion as a Smoking Cessation Aid in Alcoholics - Article


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Bupropion SR

Budeprion SR; Wellbutrin SR


Clinical Trial: Bupropion as a Smoking Cessation Aid in Alcoholics

This study is no longer recruiting patients.

Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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 Treatment or Intervention Phase
Alcoholism
Smoking
 Drug: bupropion (Wellbutrin)
Phase IV

MedlinePlus related topics:  Alcoholism;   Smoking

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

Further Study Details: 

Expected Total Enrollment:  200

Study completion: April 2004

Eligibility

Ages Eligible for Study:  25 Years   -   75 Years,  Genders Eligible for Study:  Both

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.

Location Information


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

More Information

Study ID Numbers:  NIAAAGRA13689
Record last reviewed:  November 2004
Last Updated:  November 15, 2004
Record first received:  August 28, 2002
ClinicalTrials.gov Identifier:  NCT00044434
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005


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October 6, 2008



Page Updated: June 1, 2005
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