Smoking Cessation for Young Adults Who Binge Drink - 1

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steven Ames, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00218452
First received: September 16, 2005
Last updated: May 16, 2012
Last verified: May 2012
  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 Phase
Adherence
Tobacco Use Cessation
Alcohol & Drug Use
Nicotine Transdermal System
Behavioral: Lifestyle counseling
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Smoking Cessation for Young Adults Who Binge Drink

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Treatment attendance [ Time Frame: week 12 and week 24 ] [ Designated as safety issue: No ]
    quantified as the percentage of sessions attended, will be summarized separately for each treatment group and compared between groups using the rank sum test. One summary will be performed for the percentage of sessions attended face-to-face and a second summary will be performed for the percentage of sessions attended either face-to-face or via telephone.


Enrollment: 41
Study Start Date: September 2005
Study Completion Date: April 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle counseling Behavioral: Lifestyle counseling
assigned to a 6-week individual behavioral treatment involving: 1) a novel brief office intervention for cigarette smoking that includes a treatment component intended to eliminate binge drinking

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Florida
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
University of North Florida
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Steven C Ames, Ph.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Steven Ames, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00218452     History of Changes
Other Study ID Numbers: 1996-04, R21DA018106, R21-18106-1, NIDA-18106-1
Study First Received: September 16, 2005
Last Updated: May 16, 2012
Health Authority: United States: Federal Government
Mayo Foundation: IRB

ClinicalTrials.gov processed this record on October 22, 2014