Behavioral Counseling for Alcohol Dependent Smokers (Nicotine Patch)

This study has been completed.

First Received on February 3, 2000. Last Updated on September 28, 2010 History of Changes

Sponsor:	Mayo Clinic
Collaborator:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	Mayo Clinic
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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Masking: Open Label Primary Purpose: Treatment
Official Title:	Mood Management Training for Alcohol Dependent Smokers

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism Smoking

Drug Information available for: Nicotine tartrate Nicotine polacrilex

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Enrollment:	144
Study Start Date:	February 1999
Study Completion Date:	January 2003
Primary Completion Date:	January 2003 (Final data collection date for primary outcome measure)

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

Mayo Clinic

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Principal Investigator:

Christ A. Patten, PhD

Mayo Clinic

More Information

No publications provided

Responsible Party:	Christ A. Patten, PhD, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00004551 History of Changes
Other Study ID Numbers:	934-97, R01AA11890
Study First Received:	February 3, 2000
Last Updated:	September 28, 2010
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Alcoholism
Smoking
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Habits
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 13, 2012