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Bupropion as a Smoking Cessation Aid in Alcoholics

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ClinicalTrials.gov Identifier: NCT00044434
Recruitment Status : Completed
First Posted : August 30, 2002
Last Update Posted : January 29, 2008
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Alcoholism Smoking Drug: bupropion (Wellbutrin) Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: Bupropion as a Smoking Cessation Aid in Alcoholics
Study Start Date : May 2002
Actual Primary Completion Date : April 2005
Actual Study Completion Date : April 2005

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U.S. FDA Resources





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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.

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)

ClinicalTrials.gov Identifier: NCT00044434     History of Changes
Other Study ID Numbers: NIAAAGRA13689
First Posted: August 30, 2002    Key Record Dates
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