College Students and Smoking Cessation - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00941395

Purpose

The goal of this study is to learn if smokers between the ages of 18 and 35 are able to complete a new smoking intervention program. Researchers will also study how difficult or easy the program is to use.

Condition	Intervention
Smoking Cessation Habits Smoking	Behavioral: Survey Behavioral: Counseling

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Enhanced Smoking Cessation for University Students

Resource links provided by NLM:

MedlinePlus related topics: Cancer Quitting Smoking Smoking

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Feasibility of smoking cessation program, using comparison of pre and post knowledge scores. [ Time Frame: Baseline and 6 month post intervention ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	June 2009
Estimated Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Smokers Smoking Cessation Intervention	Behavioral: Survey Completion of 3 surveys on the internet over the 3 months between the 1-week visit and the 3-month visit. The surveys should take about 20 minutes to complete. Other Name: Questionnaire Behavioral: Counseling Individual in-person study visits at 1 week, 3 months, and 6 months.
Experimental: Non-Smokers Smoking Prevention Intervention	Behavioral: Counseling In-person end of study visit at 6 months. Behavioral: Survey 3 Internet-based surveys over 3 months, each taking approximately 20 minutes. Other Name: Questionnaire

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Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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: 18-35 years of age
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: 18-35 years of age
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00941395

Contacts

Contact: Alex Prokhorov, MD, PHD

713-745-2382

Locations

United States, Texas
Texas A&M University	Recruiting
College Station, Texas, United States, 77843
University of Houston Central Campus	Recruiting
Houston, Texas, United States, 77004

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Alex Prokhorov, MD, PHD

UT MD Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00941395 History of Changes
Other Study ID Numbers:	2009-0351
Study First Received:	July 15, 2009
Last Updated:	January 18, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Cancer Prevention
College students
Prevention intervention
Smoking

Tobacco
Internet-based
Cognitive Behavioral Therapy
Nicotine lozenges

Additional relevant MeSH terms:

Smoking
Habits

ClinicalTrials.gov processed this record on February 09, 2012