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Smoking Cessation for Young Adults Who Binge Drink - 1

Primary Purpose

Adherence, Tobacco Use Cessation, Alcohol & Drug Use

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lifestyle counseling
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adherence focused on measuring Tobacco use cessation

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mayo Clinic Jacksonville
  • University of North Florida
  • Mayo Clinic Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lifestyle counseling

Arm Description

Outcomes

Primary Outcome Measures

Treatment attendance
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.

Secondary Outcome Measures

Full Information

First Posted
September 16, 2005
Last Updated
April 6, 2015
Sponsor
Mayo Clinic
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00218452
Brief Title
Smoking Cessation for Young Adults Who Binge Drink - 1
Official Title
Smoking Cessation for Young Adults Who Binge Drink
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adherence, Tobacco Use Cessation, Alcohol & Drug Use, Nicotine Transdermal System
Keywords
Tobacco use cessation

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle counseling
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle counseling
Intervention Description
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
Primary Outcome Measure Information:
Title
Treatment attendance
Description
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.
Time Frame
week 12 and week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven C Ames, Ph.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
University of North Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

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Smoking Cessation for Young Adults Who Binge Drink - 1

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