Behavioral Counseling for Alcohol Dependent Smokers (Nicotine Patch)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004551
Recruitment Status : Completed
First Posted : February 4, 2000
Last Update Posted : September 29, 2010
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:
Mayo Clinic

Brief Summary:
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 or disease Intervention/treatment Phase
Alcoholism Smoking Drug: nicotine replacement patch Behavioral: mood management Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mood Management Training for Alcohol Dependent Smokers
Study Start Date : February 1999
Actual Primary Completion Date : January 2003
Actual Study Completion Date : January 2003

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00004551

United States, Minnesota
Department of Internal Medicine, Mayo Foundation
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Christ A. Patten, PhD Mayo Clinic

Responsible Party: Christ A. Patten, PhD, Mayo Clinic Identifier: NCT00004551     History of Changes
Other Study ID Numbers: 934-97
R01AA011890 ( U.S. NIH Grant/Contract )
First Posted: February 4, 2000    Key Record Dates
Last Update Posted: September 29, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action