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Smoking Cessation for Young Adults Who Binge Drink - 1
This study is currently recruiting participants.
Verified by National Institute on Drug Abuse (NIDA), September 2005
First Received: September 16, 2005   Last Updated: February 21, 2007   History of Changes
Sponsors and Collaborators: National Institute on Drug Abuse (NIDA)
Mayo Clinic
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00218452
  Purpose

The purpose of this study is develop and test the success of a new smoking cessation intervention that includes a component to eliminate binge drinking.


Condition Intervention
Adherence
Tobacco Use Cessation
Alcohol & Drug Use
Nicotine Transdermal System
Behavioral: Tobacco Use Cessation

MedlinePlus related topics: Quitting Smoking Smoking
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: Smoking Cessation for Young Adults Who Binge Drink

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

Primary Outcome Measures:
  • Treatment compliance

Estimated Enrollment: 74
Study Start Date: September 2005
Detailed Description:

The primary aim of this pilot investigation is to develop and evaluate the acceptability and feasibility of a novel tobacco dependence intervention that includes a component to eliminate binge drinking. This study will also estimate the magnitude of the effect of the novel intervention on the cigarette smoking behavior of young adult college student smokers.

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

(1) Aged 18-25 years. (2) Enrolled as a student at a two or four year technical or non-technical college or university. (3) Smoked > 10 or more cigarettes per day during the past 6 months. (4) Binge drank on > 2 occasions per month during the past 3 months. Binge drinking is defined as consumption of > 5 standardized alcoholic drinks in a row for males or > 4 drinks in a row for females. (5) Able to participate fully in all aspects of the intervention and keep all scheduled appointments. (6) Willing to participate in 6 months of follow-up. (7) Willing to stop smoking and use nicotine patch therapy. (8) Willing to refrain from participating in additional smoking interventions for the duration of the study. (9) Provide written informed consent. (10) General good health as determined by screening physician or registered nurse.

Exclusion Criteria:

  1. Current (past 90 days) alcohol dependence as assessed by the Structured Clinical Interview for DSM-IV Axis I Disorders, Alcohol Dependence Module.
  2. Current (past 12 months) non-nicotine or alcohol drug dependence as assessed by a Drug Abuse Screening Test-20 score of > 6. (3) Current elevation of depressive symptoms (past 2 weeks) that would be indicative of clinical depression as assessed by a Beck Depression Inventory-II score of > 20. (4) Current use (past 30 days) of nicotine containing medication or tobacco products other than cigarettes. (5) Current use (past 30 days) of any other smoking cessation treatment involving behavioral or pharmacological interventions. (6) Any medical condition that would preclude use of the nicotine patch including current unstable angina, recent history (past 30 days) of myocardial infarction or stroke, history of severe skin allergies, or evidence of severe chronic dermatosis.

(7) Currently pregnant or breast feeding, or likely to become pregnant during the nicotine patch phase.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00218452

Contacts
Contact: Edgar Covil (904)953-7850

Locations
United States, Florida
Mayo Clinic Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Contact: Steven C Ames, Ph.D.     904-953-6822     ames.steven@mayo.edu    
University of North Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Gretchen E Ames, Ph.D.     904-620-2807        
United States, Minnesota
Mayo Clinic Rochester Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Christi Patten, Ph.D.     507-538-7370     patten.christi@mayo.edu    
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Steven C Ames, Ph.D. Mayo Clinic
  More Information

No publications provided

Study ID Numbers: NIDA-18106-1, R21-18106-1
Study First Received: September 16, 2005
Last Updated: February 21, 2007
ClinicalTrials.gov Identifier: NCT00218452     History of Changes
Health Authority: United States: Federal Government;   Mayo Foundation: IRB

Study placed in the following topic categories:
Smoking

ClinicalTrials.gov processed this record on May 07, 2009