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Bupropion as a Smoking Cessation Aid in Alcoholics

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00044434
First Posted: August 30, 2002
Last Update Posted: January 29, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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 Intervention Phase
Alcoholism Smoking Drug: bupropion (Wellbutrin) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: Bupropion as a Smoking Cessation Aid in Alcoholics

Resource links provided by NLM:


Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Estimated Enrollment: 200
Study Start Date: May 2002
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00044434


Locations
United States, Nebraska
VA/Nebraska/Western Iowa Health Care System
Omaha, Nebraska, United States, 68105
Sponsors and Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  More Information

ClinicalTrials.gov Identifier: NCT00044434     History of Changes
Other Study ID Numbers: NIAAAGRA13689
First Submitted: August 28, 2002
First Posted: August 30, 2002
Last Update Posted: January 29, 2008
Last Verified: January 2008

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors