Behavioral Counseling for Alcohol Dependent Smokers (Nicotine Patch)

Smoking Clinical Trial

Official title:

Mood Management Training for Alcohol Dependent Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004551
• Other study ID #: 934-97
• Secondary ID: R01AA011890
• Status: Completed
• Phase: Phase 4
• First received: February 3, 2000
• Last updated: September 28, 2010
• Start date: February 1999
• Est. completion date: January 2003

Study information

• Verified date: September 2010
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: January 2003
• Est. primary completion date: January 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism
• Smoking

Intervention

Drug:
• nicotine replacement patch

Behavioral:
• mood management

Locations

Country	Name	City	State
United States	Department of Internal Medicine, Mayo Foundation	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States,