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Pharmacologic Relapse Prevention for Alcoholic Smokers
This study has been completed.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsor: 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

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

Resource links provided by NLM:


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

No publications provided

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

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Disorders of Environmental Origin
Pharmacologic Actions
Mental Disorders
Therapeutic Uses
Alcoholism
Bupropion
Substance-Related Disorders
Dopamine Agents
Alcohol-Related Disorders
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on February 08, 2010