Behavioral Counseling for Alcohol Dependent Smokers (Nicotine Patch)

NCT ID: NCT00004551

Last Updated: 2010-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-02-28

Study Completion Date

2003-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alcoholism Smoking

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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nicotine replacement patch

Intervention Type DRUG

mood management

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mayo Clinic

Principal Investigators

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Christ A. Patten, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Department of Internal Medicine, Mayo Foundation

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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R01AA011890

Identifier Type: NIH

Identifier Source: secondary_id

View Link

934-97

Identifier Type: -

Identifier Source: org_study_id