Skip to main content
OpenTrials
Completed

NCT Number: NCT00004551

Behavioral Counseling for Alcohol Dependent Smokers (Nicotine Patch)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alcoholism Alcohol-Related Disorders Behavior Chemically-Induced Disorders Mental Disorders Smoking Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Internal Medicine, Mayo Foundation

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nicotine replacement patch

Drug

mood management

Behavioral

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Mood Management Training for Alcohol Dependent Smokers

Important dates

Study start
1999
Primary completion
2003
Study completion
2003
First posted
Feb 4, 2000
Registry last updated
Sep 29, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.