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Behavioral Counseling for Alcohol Dependent Smokers (Nicotine Patch)

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: NCT00004551
  Purpose

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.


Condition Intervention Phase
Alcoholism
Smoking
Drug: nicotine replacement patch
Behavioral: mood management
Phase IV

MedlinePlus related topics:   Alcoholism    Smoking   

Drug Information available for:   Nicotine polacrilex    Nicotine tartrate    Ethanol   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Efficacy Study
Official Title:   Mood Management Training for Alcohol Dependent Smokers

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

Estimated Enrollment:   144
Study Start Date:   February 1999
Study Completion Date:   January 2003

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

Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004551

Locations
United States, Minnesota
Department of Internal Medicine, Mayo Foundation    
      Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Investigators
Principal Investigator:     Christ A. Patten, PhD     Mayo Clinic    
  More Information


Study ID Numbers:   NIAAAPAT11890
First Received:   February 3, 2000
Last Updated:   December 6, 2007
ClinicalTrials.gov Identifier:   NCT00004551
Health Authority:   United States: Federal Government

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

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Agonists
Autonomic Agents
Nicotinic Agonists
Physiological Effects of Drugs
Ganglionic Stimulants
Peripheral Nervous System Agents
Cholinergic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




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