Enhanced Smoking Cessation for University Students

Cigarette Smoker Clinical Trial

Official title:

Enhanced Smoking Cessation for University Students

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00941395
• Other study ID #: 2009-0351
• Secondary ID: NCI-2018-0255220
• Status: Completed
• Phase: N/A
• Start date: June 30, 2009
• Est. completion date: June 8, 2017

Study information

• Verified date: November 2018
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial studies how well a new smoking cessation and prevention intervention works in enhancing smoking cessation for university students. The new intervention may be easier to use for students to quit smoke.

Description:

PRIMARY OBJECTIVES:

I. To establish the feasibility of a new smoking cessation and prevention intervention including two new modules addressing alcohol use and depression.

II. Demonstrate the feasibility of a smoking prevention website.

OUTLINE: Participants are assigned to 1 of 2 arms.

ARM I: Participants who currently smoke complete a survey over 30 minutes and discuss the survey results with the counselor over 30 minutes at week 2. Participants also complete 3 internet surveys over 20 minutes.

ARM II: Participants who currently do not smoke complete a survey over 30 minutes and discuss the survey results with the counselor over 30 minutes at week 2.

After completion of study, participants are followed up at 3 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: June 8, 2017
• Est. primary completion date: June 8, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• CESSATION ARM: Student at University of Houston Central Campus or Texas A&M University

• CESSATION ARM: Smoke 1 or more cigarettes a day

• CESSATION ARM: Speak and read English

• CESSATION ARM: Signed informed consent and an acknowledgement of participation requirements

• CESSATION ARM: Be enrolled in at least one class at respective campus at baseline

• CESSATION ARM: Provide current contact information

• CESSATION ARM: Have access to the Internet

• PREVENTION ARM: Student at University of Houston Central Campus or Texas A&M University

• PREVENTION ARM: Speak and read English

• PREVENTION ARM: Signed Informed Consent and an acknowledgement of participation requirements

• PREVENTION ARM: Be enrolled in at least one class at respective campus at baseline

• PREVENTION ARM: Provide current contact information

• PREVENTION ARM: Have access to the Internet

• PREVENTION ARM: Evidence of smoking susceptibility (as defined by the Smoking Susceptibility Scale)

• CESSATION ARM: Willing to answer all survey questions on all survey instruments throughout the duration of study

• PREVENTION ARM: Willing to answer all survey questions on all survey instruments throughout the duration of study

Exclusion Criteria:

• CESSATION ARM: Evidence of major depressive disorder (as defined by PHQ-9 [Patient Health Questionnaire-9])

• CESSATION ARM: Evidence of severe alcohol abuse (as defined by AUDIT [Alcohol Use Disorders Identification Test] measure)

• PREVENTION ARM: Current tobacco use

• PREVENTION ARM: Does not plan to continue as a student at their campus for at least one more year

• CESSATION ARM: Does not plan to continue as a student at their campus for at least one more year

• PREVENTION ARM: Evidence of major depressive disorder (as defined by PHQ-9 [Patient Health Questionnaire-9])

• PREVENTION ARM: Evidence of severe alcohol abuse (as defined by AUDIT measure)

• CESSATION ARM: Pregnancy

Related Conditions & MeSH terms

• Cigarette Smoker
• Current Every Day Smoker

Intervention

Other:
• Survey Administration
Complete surveys

Locations

Country	Name	City	State
United States	Texas A&M	College Station	Texas
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The ease of use and appeal of various features of the program		Up to 5 months
Primary	The quality of the interactive multi-media presentations and their ability to generate interest in smoking cessation and prevention		Up to 5 months
Primary	Behavior modification determined by EVOLVE Follow up Survey-Smoker		Up to 5 months
Primary	Knowledge of modules in the program		Up to 5 months
Primary	Feasibility defined as 90% of the student participants indicating that the intervention program is easy to use and can fit into their schedule	Associations between the dependent variables and smoking status will be evaluated with linear and logistic regression models with campus of origin and smoking status as independent predictors of these outcomes.	Up to 5 months

External Links

•   MD Anderson Cancer Center Website