Smoking CessationNCT01008748
Determinants of Smoking Cessation Among Latinos
A study testing Nicotine Replacement Therapy (NRT), Questionnaire and Counseling in people with Smoking Cessation, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Nicotine Replacement Therapy (NRT), Questionnaire and Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current daily smoker who average >/= 5 cigarettes/day for the last year
- Mexican-American (MA) Adults from the Houston-based MA Cohort Study and/or from the community
- Age 18 to 65 years
- Motivated to quit smoking in the next 30 days
- Viable (working) telephone number and home address
- Prefers to speak in Spanish
- Register "8" or more on a carbon monoxide breath test
Who cannot join
- Contraindication for nicotine patch use
- Regular use of tobacco products other than cigarettes (cigars, pipes, smokeless tobacco)
- Use of nicotine replacement therapy products or other smoking cessation medications, other than the nicotine patches supplied during the study
- Pregnancy or lactation
- Currently enrolled in a smoking cessation program
- Participation in a smoking cessation program or study during the past 90 days
- Another household member is enrolled in this protocol
- Active substance abuse problem
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
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.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Nicotine Replacement Therapy (NRT), Questionnaire, Counseling, Self-Help Materials
- Keywords
- Smoking, Latinos, Mexican American, Spanish-speaking smokers, Ecological momentary assessment, Nicotine patch, Smoking cessation counseling, Questionnaire, EMA
- Medical subject headings
- Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine Replacement Therapy (NRT)Drug
Also called Nicotine Patch Therapy
NRT for participants who smoke >10 cigarettes/day will consist of 2 weeks of 21 mg nicotine patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Nicotine Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 2 weeks of 14 mg patches and 2 weeks of 7 mg patches. Patch dispensation will occur at weekly treatment visits.
QuestionnaireBehavioural
Also called Survey
Computerized questionnaires at each of 5 visits and will take 1 1/2 hours to complete each time.
CounselingBehavioural
Each counseling session, whether face-to-face or over the phone, will last approximately 15 minutes. In-person counseling sessions occur at weeks -1, 0, and 3, with telephone counseling sessions occurring at weeks 0.5, 1, and 2. Counselors will conduct all sessions in Spanish.
Self-Help MaterialsBehavioural
Also called pamphlets
Spanish-language self-help materials currently used by the NCI's Cancer Information Service.
| Study group | Role | What they receive |
|---|---|---|
| Smoking Cessation Treatment | Experimental | Nicotine replacement therapy (NRT), self-help materials, + brief in-person and telephone counseling, all conducted in Spanish. Computerized questionnaires at each of 5 visits and will take 1 1/2 hours to complete each time. Receives: Drug: Nicotine Replacement Therapy (NRT); Behavioral: Questionnaire; Behavioral: Counseling; Behavioral: Self-Help Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With 24-Hour Smoking Abstinence (Week 3 Post Quit Day)
Biochemically verified 24-hour point prevalence abstinence rates based on a completers-only approach.
Measured: Week 3 post quit day
24-Hour Smoking Abstinence (Week 26 Post Quit Day)
Biochemically verified 24-hour point prevalence abstinence rates based on a completers-only approach.
Measured: Week 26 post quit day
7-Day Smoking Abstinence (Week 3 Post Quit Day)
Biochemically verified 7-day point prevalence abstinence rates based on a completers-only approach.
Measured: Week 3 post quit day
7-Day Smoking Abstinence (Week 26 Post Quit Day)
Biochemically verified 7-day point prevalence abstinence rates based on a completers-only approach.
Measured: Week 26 post quit day
30-Day Smoking Abstinence (Week 26 Post Quit Day)
Biochemically verified 30-day point prevalence abstinence rates based on a completers-only approach.
Measured: Week 26 post quit day
7-Day Smoking Abstinence (Week 3 Post Quit Day) Intent to Treat
Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach
Measured: Week 3 post quit day
7-Day Smoking Abstinence (Week 26 Post Quit Day) Intent to Treat
Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach
Measured: Week 26 post quit day
7-Day Smoking Abstinence (Week 3 Post Quit Day) Continuous Abstinence
Biochemically verified 7-day point prevalence abstinence rates using a completers-only approach
Measured: Week 3 post quit day
7-Day Smoking Abstinence (Week 26 Post Quit Day) Continuous Abstinence
Biochemically verified 7-day point prevalence abstinence rates using a completers-only approach
Measured: Week 26 post quit day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Department of Health and Human Services, National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- David Wetter, PhD, MS, BA, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01008748
- Sponsor's protocol ID
- 2007-0442
- Other IDs
- 2P60MD000503-05
- Status last verified
- Mar 2020
- First submitted
- 2 Oct 2009
- Last updated
- 19 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 34323541
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Smoking Cessation Among Latinos
- ClinicalTrials.gov ID
- NCT01008748
- Acronym / sponsor ID
- 2007-0442
- Conditions
- Smoking Cessation
- Keywords
- Smoking, Latinos, Mexican American, Spanish-speaking smokers, Ecological momentary assessment, Nicotine patch, Smoking cessation counseling, Questionnaire
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Department of Health and Human Services, National Institutes of Health (NIH)
- Study start
- Sep 2009
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 6 Nov 2009 (estimated)
- Results
- Posted 19 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smoking Cessation Treatment | Experimental | Drug: Nicotine Replacement Therapy (NRT), Behavioral: Questionnaire, Behavioral: Counseling, Behavioral: Self-Help MaterialsNicotine replacement therapy (NRT), self-help materials, + brief in-person and telephone counseling, all conducted in Spanish. Computerized questionnaires at each of 5 visits and will take 1 1/2 hours to complete each time. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Current daily smoker who average >/= 5 cigarettes/day for the last year
- Mexican-American (MA) Adults from the Houston-based MA Cohort Study and/or from the community
- Age 18 to 65 years
- Motivated to quit smoking in the next 30 days
- Viable (working) telephone number and home address
Key exclusion criteria (8 listed)
- Contraindication for nicotine patch use
- Regular use of tobacco products other than cigarettes (cigars, pipes, smokeless tobacco)
- Use of nicotine replacement therapy products or other smoking cessation medications, other than the nicotine patches supplied during the study
- Pregnancy or lactation
- Currently enrolled in a smoking cessation program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine Replacement Therapy (NRT)Also: Nicotine Patch TherapyNRT for participants who smoke >10 cigarettes/day will consist of 2 weeks of 21 mg nicotine patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Nicotine Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 2 weeks of 14 mg patches and 2 weeks of 7 mg patches. Patch dispensation will occur at weekly treatment visits. | Drug | Smoking Cessation Treatment |
| QuestionnaireAlso: SurveyComputerized questionnaires at each of 5 visits and will take 1 1/2 hours to complete each time. | Behavioural | Smoking Cessation Treatment |
| CounselingEach counseling session, whether face-to-face or over the phone, will last approximately 15 minutes. In-person counseling sessions occur at weeks -1, 0, and 3, with telephone counseling sessions occurring at weeks 0.5, 1, and 2. Counselors will conduct all sessions in Spanish. | Behavioural | Smoking Cessation Treatment |
| Self-Help MaterialsAlso: pamphletsSpanish-language self-help materials currently used by the NCI's Cancer Information Service. | Behavioural | Smoking Cessation Treatment |
Primary outcome
Number of Participants With 24-Hour Smoking Abstinence (Week 3 Post Quit Day)
Time frame: Week 3 post quit day
Biochemically verified 24-hour point prevalence abstinence rates based on a completers-only approach.
24-Hour Smoking Abstinence (Week 26 Post Quit Day)
Time frame: Week 26 post quit day
Biochemically verified 24-hour point prevalence abstinence rates based on a completers-only approach.
7-Day Smoking Abstinence (Week 3 Post Quit Day)
Time frame: Week 3 post quit day
Biochemically verified 7-day point prevalence abstinence rates based on a completers-only approach.
7-Day Smoking Abstinence (Week 26 Post Quit Day)
Time frame: Week 26 post quit day
Biochemically verified 7-day point prevalence abstinence rates based on a completers-only approach.
30-Day Smoking Abstinence (Week 26 Post Quit Day)
Time frame: Week 26 post quit day
Biochemically verified 30-day point prevalence abstinence rates based on a completers-only approach.
7-Day Smoking Abstinence (Week 3 Post Quit Day) Intent to Treat
Time frame: Week 3 post quit day
Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach
7-Day Smoking Abstinence (Week 26 Post Quit Day) Intent to Treat
Time frame: Week 26 post quit day
Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach
7-Day Smoking Abstinence (Week 3 Post Quit Day) Continuous Abstinence
Time frame: Week 3 post quit day
Biochemically verified 7-day point prevalence abstinence rates using a completers-only approach
7-Day Smoking Abstinence (Week 26 Post Quit Day) Continuous Abstinence
Time frame: Week 26 post quit day
Biochemically verified 7-day point prevalence abstinence rates using a completers-only approach
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34323541Vinci 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.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Wetter, PhD, MS, BA principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine Replacement Therapy (NRT), Questionnaire and Counseling in people with Smoking Cessation, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With 24-Hour Smoking Abstinence (Week 3 Post Quit Day) (time frame: Week 3 post quit day). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01008748, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2020.