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, 2014
Last verified: October 2014
  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 2016 (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
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: 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 M.D. 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, 2R01CA069425-08A2
Study First Received: July 15, 2009
Last Updated: October 9, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by M.D. Anderson Cancer Center:
Cancer Prevention
College students
Prevention intervention
Smoking
Tobacco
Internet-based
Cognitive Behavioral Therapy
Nicotine lozenges

ClinicalTrials.gov processed this record on October 20, 2014