search
Back to results

Behavioral Counseling for Alcohol Dependent Smokers (Nicotine Patch)

Primary Purpose

Alcoholism, Smoking

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
nicotine replacement patch
mood management
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Internal Medicine, Mayo Foundation

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 3, 2000
Last Updated
September 28, 2010
Sponsor
Mayo Clinic
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
search

1. Study Identification

Unique Protocol Identification Number
NCT00004551
Brief Title
Behavioral Counseling for Alcohol Dependent Smokers (Nicotine Patch)
Official Title
Mood Management Training for Alcohol Dependent Smokers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
February 1999 (undefined)
Primary Completion Date
January 2003 (Actual)
Study Completion Date
January 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mayo Clinic
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism, Smoking

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
nicotine replacement patch
Intervention Type
Behavioral
Intervention Name(s)
mood management

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christ A. Patten, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Internal Medicine, Mayo Foundation
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Behavioral Counseling for Alcohol Dependent Smokers (Nicotine Patch)

We'll reach out to this number within 24 hrs