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Improving Smoking Cessation Outcomes in Heavy Drinkers - 1

This study is currently recruiting participants.
Verified by National Institute on Drug Abuse (NIDA), January 2006

Sponsored by: National Institute on Drug Abuse (NIDA)
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00107575
  Purpose

To test the effectiveness of an smoking cessation treatment for smokers who also drink alcohol heavily.


Condition Intervention
Tobacco Use Disorder
Behavioral: Behavior Therapy

MedlinePlus related topics:   Smoking    Smoking Cessation   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Factorial Assignment
Official Title:   Improving Smoking Cessation Outcomes in Heavy Drinkers

Further study details as provided by National Institute on Drug Abuse (NIDA):

Estimated Enrollment:   250
Study Start Date:   August 2003

  Eligibility
Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

1.) be at least 18 years of age, 2.) have smoked cigarettes regularly for at least one year, 3.) currently smoke at least 10 cigarettes a day, 4.) currently be using no other tobacco products or nicotine replacement therapy, 5.) currently drink heavily according to self-report (>14 drinks per week or >5 drinks per occasion at least once per month over the last 12 months for men; >7 drinks per week or >4 drinks per occasion at least once per month over the past 12 months for women)

Inclusion Criteria:

1.) be at least 18 years of age, 2.) have smoked cigarettes regularly for at least one year, 3.) currently smoke at least 10 cigarettes a day, 4.) currently be using no other tobacco products or nicotine replacement therapy, 5.) currently drink heavily according to self-report (>14 drinks per week or >5 drinks per occasion at least once per month over the last 12 months for men; >7 drinks per week or >4 drinks per occasion at least once per month over the past 12 months for women).

Exclusion Criteria:

1.) meet full DSM-IV criteria for alcohol dependence in the past 12 months; 2.) meet criteria for other current psychoactive substance abuse or dependence (excluding nicotine dependence and alcohol abuse) in the past 12 months [this would also exclude individuals with lifetime substance dependence who continue to have some abuse/dependence symptoms in the past 12 months]; 3.) meet criteria for current dysthymia, major depression, or manic episode [past month]; 4.) are currently psychotic [past 12 months] or suicidal [suicidal ideation or intent in the past month]; 5.) have an unstable medical condition that would suggest caution in the use of the nicotine patch (e.g., unstable angina pectoris, arrhythmia, recent congestive heart failure); 6.) are currently pregnant or lactating or intend to become pregnant. We also will exclude participants who are not alcohol dependent but who have characteristics that might make supervised alcohol detoxification necessary (e.g., morning drinking to avoid withdrawal, daily drinking of >12 drinks, recent withdrawal symptoms, history of severe withdrawal symptoms such as hallucinations, seizures, or delirium tremens).

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00107575

Contacts
Contact: Christopher W Kahler, Ph.D.     (401)444-1882     christopher_kahler@brown.edu    

Locations
United States, Rhode Island
Brown University     Recruiting
      Providence, Rhode Island, United States, 02912
      Contact: Christopher W Kahler, Ph.D.     401-444-1882     christopher_kahler@brown.edu    

Sponsors and Collaborators

Investigators
Principal Investigator:     Christopher W Kahler, Ph.D.     Brown University    
  More Information


Study ID Numbers:   NIDA-15534-1, R01-15534-1
First Received:   April 5, 2005
Last Updated:   January 12, 2006
ClinicalTrials.gov Identifier:   NCT00107575
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Smoking
Mental Disorders
Tobacco Use Disorder
Substance-Related Disorders
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on September 23, 2008




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