Completed

Mood Management Training for Alcohol Dependent Smokers

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

nicotine replacement patch

+ mood management

DrugBehavioral
Who is being recruted

Behavior+4

+ Mental Disorders

+ Substance-Related Disorders

Over 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: February 1999
See protocol details

Summary

Principal SponsorMayo Clinic
Last updated: September 29, 2010
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 1999

Actual date on which the first participant was enrolled.

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.

NCT00004551
Principal SponsorMayo Clinic
Last updated: September 29, 2010
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

144 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorMental DisordersSubstance-Related DisordersAlcohol-Related DisordersChemically-Induced DisordersAlcoholismSmoking

Criteria

7 inclusion criteria required to participate
Able to fully participate in all aspects of the study
Currently abstinent from alcohol and other drugs for at least 3 months
Meets criteria for alcohol dependence
Meets criteria for history of major depression independent of alcohol use
Show More Criteria
4 exclusion criteria prevent from participating
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
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
Currently pregnant, breast feeding or likely to become pregnant during the nicotine patch phase of the study

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Department of Internal Medicine, Mayo Foundation

Rochester, United StatesOpen Department of Internal Medicine, Mayo Foundation in Google Maps
CompletedOne Study Center