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Pharmacologic Relapse Prevention for Alcoholic Smokers

This study has been completed.

Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT00000457
  Purpose

This study will compare the long-term use of bupropion (Wellbutrin) and placebo for reducing the rate of smoking relapse in recovering alcoholics who achieved initial abstinence from smoking with nicotine patch therapy. The study will also determine the cessation rate in the 8th week of treatment among recovering alcoholics using a nicotine patch. The patch dose is projected to serve as a 100-percent replacement.


Condition Intervention Phase
Alcoholism
Smoking
Drug: nicotine replacement patch
Drug: bupropion (Wellbutrin)
Phase II

MedlinePlus related topics:   Alcoholism    Smoking   

Drug Information available for:   Bupropion hydrochloride    Bupropion    Nicotine polacrilex    Nicotine tartrate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Official Title:   Pharmacologic Relapse Prevention for Alcoholic Smokers

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

Estimated Enrollment:   292
Estimated Study Completion Date:   August 2001

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • History of alcohol dependence and at least one year of abstinence from alcohol intake.
  • Has a history of smoking 20 or more cigarettes per day for the prior year.
  • Can read and write English.
  • Stated ability to fully participate in the study and keep all scheduled appointments.
  • Has provided written informed consent.
  • General good health.

Exclusion Criteria:

  • Recent history (within three months) of a clinically significant myocardial infarction, unstable angina pectoris, serious cardiac arrhythmia or any other medical condition which the physician investigator deems incompatible with study participation.
  • Current major depression. A past history of major depression will not be an exclusionary criteria.
  • Current or previous use of bupropion (Wellbutrin).
  • Active non- nicotine drug dependence.
  • Past or current history of bipolar disorder, pain disorder or psychosis, schizophrenia, or other major psychiatric disorders.
  • Current medically indicated use of psychiatric drugs.
  • Females who are pregnant, lactating, or likely to become pregnant during the first year which includes the nicotine patch and bupropion (Wellbutrin) phase.
  • History of severe skin allergies or evidence of severe chronic skin disorders.
  • Current use of nicotine containing medication or tobacco products other than cigarettes.
  • Current use (within 30 days of initiation of patch therapy) of the following medications for smoking cessation: clonidine, buspirone, or doxepin.
  • A predisposition to seizures.
  • A history of or current diagnosis of anorexia nervosa or bulimia.
  • Medical disorder that would interfere with the absorption, metabolism, or excretion of bupropion (Wellbutrin).
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000457

Locations
United States, Minnesota
Mayo Clinic Rochester    
      Rochester, Minnesota, United States, 55905

Sponsors and Collaborators
  More Information


Study ID Numbers:   NIAAAHUR11219
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00000457
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Nicotine polacrilex
Smoking
Nicotine
Mental Disorders
Bupropion
Alcoholism
Substance-Related Disorders
Disorders of Environmental Origin
Alcohol-Related Disorders

ClinicalTrials.gov processed this record on December 03, 2008




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