College Students and Smoking Cessation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00941395
First received: July 15, 2009
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

Objectives:

This study will help to establish the feasibility of a new smoking cessation and prevention intervention including two new modules addressing alcohol use and depression. In addition, we will demonstrate the feasibility of a smoking prevention website. Both cessation and prevention programs will be tailored to the needs of culturally diverse urban (University of Houston) and rural (Texas A&M) university campuses.


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:


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 2015 (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

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  1. CESSATION ARM: Student at University of Houston Central Campus or Texas A&M University
  2. CESSATION ARM: Smoke 1 or more cigarettes a day
  3. CESSATION ARM: Speak and read English
  4. CESSATION ARM: Signed Informed Consent and an acknowledgement of participation requirements
  5. CESSATION ARM: 18-35 years of age
  6. CESSATION ARM: Be enrolled in at least one class at respective campus at baseline
  7. CESSATION ARM: Provide current contact information
  8. CESSATION ARM: Have access to the Internet
  9. PREVENTION ARM: Student at University of Houston Central Campus or Texas A&M University
  10. PREVENTION ARM: Speak and read English
  11. PREVENTION ARM: Signed Informed Consent and an acknowledgement of participation requirements
  12. PREVENTION ARM: 18-35 years of age
  13. PREVENTION ARM: Be enrolled in at least one class at respective campus at baseline
  14. PREVENTION ARM: Provide current contact information
  15. PREVENTION ARM: Have access to the Internet
  16. PREVENTION ARM: Evidence of smoking susceptibility (as defined by the Smoking Susceptibility Scale)
  17. CESSATION ARM: Willing to answer all survey questions on all survey instruments throughout the duration of study
  18. PREVENTION ARM: Willing to answer all survey questions on all survey instruments throughout the duration of study

Exclusion Criteria:

  1. CESSATION ARM: Evidence of major depressive disorder (as defined by PHQ-9 [Patient Health Questionnaire-9])
  2. CESSATION ARM: Evidence of severe alcohol abuse (as defined by AUDIT [Alcohol Use Disorders Identification Test] measure)
  3. PREVENTION ARM: Current tobacco use
  4. PREVENTION ARM: Does not plan to continue as a student at their campus for at least one more year
  5. CESSATION ARM: Does not plan to continue as a student at their campus for at least one more year
  6. PREVENTION ARM: Evidence of major depressive disorder (as defined by PHQ-9 [Patient Health Questionnaire-9])
  7. PREVENTION ARM: Evidence of severe alcohol abuse (as defined by AUDIT measure)
  8. CESSATION ARM: Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00941395

Locations
United States, Texas
Texas A&M University
College Station, Texas, United States, 77843
University of Houston Central Campus
Houston, Texas, United States, 77004
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Alex Prokhorov, MD, PHD UT MD Anderson Cancer Center
  More Information

Additional Information:
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: October 9, 2013
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 April 23, 2014