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Behavioral Counseling for Alcohol Dependent Smokers (Nicotine Patch)
This study has been completed.
Study NCT00004551   Information provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First Received: February 3, 2000   Last Updated: December 6, 2007   History of Changes

February 3, 2000
December 6, 2007
February 1999
 
 
 
Complete list of historical versions of study NCT00004551 on ClinicalTrials.gov Archive Site
 
 
 
Behavioral Counseling for Alcohol Dependent Smokers (Nicotine Patch)
Mood Management Training for Alcohol Dependent Smokers

This study is to evaluate the effectiveness of a mood management intervention on abstinent alcoholic smokers with a history of major depression. The second aim is to determine the effect of smoking treatments on alcohol abstinence and to identify factors associated with smoking and alcohol outcomes (e.g., more days of abstinence). A randomized, two-group design will be used to evaluate the added benefit of mood management compared to a state-of-the-art smoking cessation treatment. Treatment will consist of 8 weekly group sessions and 1, 3, 6, and 12-month follow-up.

 
Phase IV
Interventional
Treatment, Randomized, Open Label, Efficacy Study
  • Alcoholism
  • Smoking
  • Drug: nicotine replacement patch
  • Behavioral: mood management
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
144
January 2003
 

Inclusion Criteria:

  • Meets criteria for alcohol dependence.
  • Currently abstinent from alcohol and other drugs for at least 3 months.
  • Meets criteria for history of major depression independent of alcohol use.
  • Smoked an average of 10 or more cigarettes per day during the past month.
  • Able to fully participate in all aspects of the study.
  • Willing to participate in eight 2-hour treatment sessions and 12 months of followup.
  • Willing to stop smoking and wear a nicotine patch for six consecutive weeks and refrain from participating in additional smoking interventions for the duration of treatment.

Exclusion Criteria:

  • Current episode of major depression (within the last 3 months) or current or lifetime history of bipolar disorder, schizophrenia or other major psychiatric disorders.
  • Current use of antidepressant, other psychotropic medications, smokeless tobacco, nicotine replacement or other smoking cessation therapy.
  • Any medical condition that would preclude use of the nicotine patch including current unstable angina, recent history (within 1 month) of myocardial infarction or stroke, history of severe skin allergies or evidence of severe chronic dermatoses.
  • Currently pregnant, breast feeding or likely to become pregnant during the nicotine patch phase of the study.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004551
 
NIAAAPAT11890
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 
Principal Investigator: Christ A. Patten, PhD Mayo Clinic
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP