Clinical trial NCT01008748: Determinants of Smoking Cessation Among Latinos
Official title: Determinants of Smoking Cessation Among Latinos
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Smoking
Latinos
Mexican American
Spanish-speaking smokers
Ecological momentary assessment
Nicotine patch
Smoking cessation counseling
Questionnaire
EMA
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: Department of Health and Human Services
name: National Institutes of Health (NIH)
First posted: 2009-11-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to learn how neighborhood and individual factors affect the ability to stop smoking among Spanish-speaking Mexican American (MA) smokers who want to quit smoking.

Detailed description: If you agree to take part in this study, 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. Over the next 6 months, you will visit M. D. Anderson 5 times during this study. You will also be called 3 times for smoking cessation counseling during this study.

Study Visits:

First (Orientation) Visit You will be asked about your feelings and moods, as well as how many cigarettes you smoke. You will fill out questionnaires on a computer. The questionnaires will be about your mood, stress level, and smoking-related issues. They should take about 1 hour and 30 minutes to complete.

You will complete a breath test. For the breath test, you will blow into a tube that's attached to a machine that is used to estimate the amount of tobacco smoke that you inhale.

You will give two saliva samples at this visit. To collect the first saliva sample, you will place a piece of cotton in your mouth for 3 minutes. The saliva sample is used to check the amount of cotinine in the body. Cotinine is a chemical that is produced in your saliva when your body breaks down nicotine.

The second saliva sample will be collected by spitting into a container. Researchers will perform genetic tests with these samples to look for genes that control the production and use of neurotransmitters, naturally occurring chemical messengers in the brain. People with certain genes may have a more difficult time quitting smoking, because of the way nicotine affects these chemicals. Your second saliva sample will be stored in a biorepository at M. D. Anderson for use in future research related to nicotine addiction, smoking, and/or cancer. Your saliva sample will be placed in a bank of biological samples and data that is available to researchers conducting research related to cancer or nicotine dependence.

Before your saliva sample can be used for research, the people doing the research must get specific approval from the Institutional Review Board (IRB) of M. D. Anderson. The IRB is a committee made up of doctors, researchers, and members of the community. The IRB is responsible for protecting the participants involved in research studies and making sure all research is done in a safe and ethical manner. All research done at M. D. Anderson, including research involving your saliva sample from this bank, must first be approved by the IRB.

Your samples will be given a code number. No identifying information will be directly linked to your samples. Only the researcher in charge of the bank will have access to the code numbers and be able to link the samples to you. Other researchers using your samples will not be able to link this data to you.

Genetic information obtained will not be provided to you.

Second (Baseline) Visit:

Your second visit (Baseline) will occur 1 week before your Quit date visit. You will fill out questionnaires on a computer. The questionnaires will be about your, stress level, social support and smoking-related issues. They should take about 1 hour and 30 minutes to complete.

You will complete a breath test. For the breath test, you will blow into a tube that's attached to a machine that is used to estimate the amount of tobacco smoke that you inhale.

Your Height, Weight and Waist circumference measures will be taken.

You will also receive individual counseling. During counseling, you will discuss techniques to help you quit smoking.

In addition, you will receive a small, hand-held personal computer and be trained in how to use it. You will carry this computer with you for 4 weeks. 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. This computer will not wake you during the night and you will be able to wait to answer questions for a few minutes if it goes off when you are busy. Answering the questions should take about 5 to 10 minutes.

Third (Quit Day) and Fourth (Week 3) Study Visits:

Your Third visit (Quit Day) will occur 1 week after your Second (Baseline) visit. Your Fourth visit will occur 3 weeks after your Quit Day. During these visits, you will be asked to fill out questionnaires on a computer about your moods and feelings, as well as how many cigarettes you smoke. The questionnaires should take about 30 minutes to complete.

You will also receive individual counseling. During counseling, you will discuss techniques to help you quit smoking.

On your Third visit, you will complete the breath test and your Weight and Waist circumference measures will also be taken.

At your Third visit you will be given a supply of nicotine patches to last until your Fourth visit.

At your Fourth visit you will be given a one week supply of nicotine patches. You will be on nicotine patches for a total of 4 weeks. At the Fourth Visit, you will also complete the breath test, will give a saliva sample and your Weight and Waist circumference measures will be taken.

Last (Week 26) Visit:

This visit will occur 26 weeks (or 6 months) after your Quit Day. During these visits, you will be asked to fill out questionnaires on a computer about your moods and feelings, as well as how many cigarettes you smoke.

The questionnaires should take about 1 1/2 hours to complete.

You will complete the breath test, your Weight and Waist circumference measures will be taken and you will also give a saliva sample at the last (Week 26) visit.

Telephone Calls:

Between your first (Orientation) visit and your Fourth (Week 3) visit, you will receive 3 calls from a smoking cessation counselor. You will receive your first call a few days before your quit day. You will receive a second call 1 week after your Quit Day and another call 2 weeks after your Quit Day. During these calls, you will discuss techniques to help you quit smoking. These calls will last 10 to 15 minutes and will be scheduled in advance.

Additional Information:

You may be contacted by mail, telephone, and/or e-mail throughout the study to remind you about 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.

Length of Study:

You will be considered off study when you complete the Week 26 (or Last) visit.

This is an investigational study. The nicotine patch is FDA approved and commercially available. Up to 200 participants will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility criteria: Inclusion Criteria:

1. Current daily smoker who average \>/= 5 cigarettes/day for the last year
2. Mexican-American (MA) Adults from the Houston-based MA Cohort Study and/or from the community
3. Age 18 to 65 years
4. Motivated to quit smoking in the next 30 days
5. Viable (working) telephone number and home address
6. Prefers to speak in Spanish
7. Register "8" or more on a carbon monoxide breath test

Exclusion Criteria:

1. Contraindication for nicotine patch use
2. Regular use of tobacco products other than cigarettes (cigars, pipes, smokeless tobacco)
3. Use of nicotine replacement therapy products or other smoking cessation medications, other than the nicotine patches supplied during the study
4. Pregnancy or lactation
5. Currently enrolled in a smoking cessation program
6. Participation in a smoking cessation program or study during the past 90 days
7. Another household member is enrolled in this protocol
8. Active substance abuse problem

Primary outcomes:
measure: Number of Participants With 24-Hour Smoking Abstinence (Week 3 Post Quit Day)
timeFrame: Week 3 post quit day
measure: 24-Hour Smoking Abstinence (Week 26 Post Quit Day)
timeFrame: Week 26 post quit day
measure: 7-Day Smoking Abstinence (Week 3 Post Quit Day)
timeFrame: Week 3 post quit day
measure: 7-Day Smoking Abstinence (Week 26 Post Quit Day)
timeFrame: Week 26 post quit day
measure: 30-Day Smoking Abstinence (Week 26 Post Quit Day)
timeFrame: Week 26 post quit day
measure: 7-Day Smoking Abstinence (Week 3 Post Quit Day) Intent to Treat
timeFrame: Week 3 post quit day
measure: 7-Day Smoking Abstinence (Week 26 Post Quit Day) Intent to Treat
timeFrame: Week 26 post quit day
measure: 7-Day Smoking Abstinence (Week 3 Post Quit Day) Continuous Abstinence
timeFrame: Week 3 post quit day
measure: 7-Day Smoking Abstinence (Week 26 Post Quit Day) Continuous Abstinence
timeFrame: Week 26 post quit day
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: David Wetter, PhD, MS, BA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vinci C, Cambron C, Lam C, Wetter DW. Perceived discrimination and smoking lapse among Mexican Americans: An ecological momentary assessment study. Health Psychol. 2021 Jun;40(6):388-397. doi: 10.1037/hea0001093.