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Risk Perception Among Quitting Smokers
This study is ongoing, but not recruiting participants.
First Received: October 4, 2006   Last Updated: January 26, 2009   History of Changes
Sponsors and Collaborators: M.D. Anderson Cancer Center
Centers for Disease Control and Prevention
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00384696
  Purpose

Primary Objectives:

  1. Compare real-time changes in smoking-relevant risk perceptions over time among smokers who successfully abstain from smoking and those who relapse during a minimal contact cessation intervention.
  2. Examine the relationship between contextual factors including affective state, craving, smoking, and levels of perceived smoking-relevant risk over time utilizing real-time assessments.
  3. Examine the relationship between risk perceptions assessed in the natural environment over time, a standard questionnaire measure of risk perception, and implicit associations in memory between smoking, disease, and fear using implicit cognition task data, and to compare the relative strength of these associations among abstainers and relapsers.

Condition Intervention Phase
Smoking
Behavioral: Nicotine Replacement Therapy
Behavioral: Questionnaire
Phase I

Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Health Communications and Risk Processing Among Smokers

Resource links provided by NLM:


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

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 220
Study Start Date: February 2006
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Treatment to help quit smoking, including written self-help materials, counseling, and 4 week supply of nicotine patch plus 5 MD Anderson Visits.
Behavioral: Nicotine Replacement Therapy
4 Weeks of nicotine patch.
Behavioral: Questionnaire
Survey taking 1 and 1/2 hours at each study visit.

Detailed Description:

If you agree to participate, you will receive treatment to help you quit smoking, including written self-help materials, counseling, and a supply of the nicotine patch for 4 weeks. You will visit M. D. Anderson 5 times during this study; once for an orientation/intake visit, and then for 4 more study visits.

At the first (orientation) visit, you will be asked about your feelings and moods, as well as your smoking status. You will fill out questionnaires on a computer and complete a breath test. The questionnaires will be about mood, stress, and smoking-related issues, and should take about 1 hour and 30 minutes to complete. To complete the breath test, you will blow into a tube that's attached to a machine about the size of a pocket computer. The breath test is used to estimate the amount of tobacco smoke that you inhale. You will also complete two computer-based tasks. Women who are pregnant should not take part in this study.

In addition, you will receive a palmtop personal computer and be trained in how to use it. You will carry this small computer with you from the time of your first visit until your last study visit. You will use the computer to answer questions about your mood, stress, and smoking-related issues. You will be asked to fill out some questions on the computer each time you have an urge to smoke or you actually smoke. Also, the computer will "beep" at random and set times and request that you answer some questions.

You will return for 4 visits after the orientation session. During these visits, you will receive brief individual counseling where you will discuss techniques to help you quit smoking. You will also be asked to fill out questionnaires on a computer about your moods and feelings, as well as your smoking status. The questionnaires should take about 30 minutes to complete. The breath test will be given at every clinic visit.

You may be contacted by mail, telephone, and/or e-mail throughout the study and follow-up period, to provide reminders of clinic visits. You may also be asked for information about your smoking status during the usual reminder calls and/or calls to reschedule missed appointments.

A supply of the nicotine patch will be provided to you at each counseling session. The final supply of the patch is provided at the final counseling session.

This is an investigational study. The nicotine patch used in this study is approved by the Food and Drug Administration (FDA). About 20 people will take part in a pilot phase of this study; then, another 200 participants will take part in the main study. All will be enrolled at M. D. Anderson.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Current smoker, age 18 to 65 years, with history of 5 cigarettes/day for last year wishing to quit.

Criteria

Inclusion Criteria:

  1. Age 18 to 65 years.
  2. Current smoker with a history of at least 5 cigarettes/day for the last year
  3. Motivated to quit within the next week.
  4. Home address and a functioning home telephone number.
  5. Can speak, read, and write in English at a sixth-grade literacy level.

Exclusion Criteria:

  1. Contraindication for nicotine patch use.
  2. Active substance abuse or dependence.
  3. Regular use of tobacco products other than cigarettes (cigars, pipes, smokeless).
  4. Use of bupropion or nicotine products other than the nicotine patches supplied by the study.
  5. Pregnancy or lactation.
  6. Another household member enrolled in the study.
  7. Participation in a smoking cessation program or study during the past 90 days.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00384696

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Jennifer Irvin Vidrine, PhD U.T.M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: UT MD Anderson Cancer Center ( Jennifer Irvin Vidrine, PhD )
Study ID Numbers: 2004-0806
Study First Received: October 4, 2006
Last Updated: January 26, 2009
ClinicalTrials.gov Identifier: NCT00384696     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Risk Perception
Smoking Cessation
Nicotine Replacement Therapy
Questionnaire
Nicotine

Study placed in the following topic categories:
Nicotine polacrilex
Smoking
Neurotransmitter Agents
Nicotine
Nicotinic Agonists
Peripheral Nervous System Agents
Cholinergic Agents

Additional relevant MeSH terms:
Neurotransmitter Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Nicotinic Agonists
Physiological Effects of Drugs
Cholinergic Agents
Pharmacologic Actions
Smoking
Habits
Nicotine
Autonomic Agents
Ganglionic Stimulants
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 03, 2009