SmokingNCT00384696
Risk Perception Among Quitting Smokers
An observational study of Smoking, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this behavioral research study is to put together and study a treatment for nicotine dependence that looks at how participant's thoughts and feelings about smoking may be related to how successfully they 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
- What is being tested?
- Nicotine Replacement Therapy and Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2006to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Current smoker, age 18 to 65 years, with history of 5 cigarettes/day for last year wishing to quit
Who may be able to join
- Age 18 to 65 years.
- Current smoker with a history of at least 5 cigarettes/day for the last year
- Motivated to quit within the next week.
- Home address and a functioning home telephone number.
- Can speak, read, and write in English at a sixth-grade literacy level.
Who cannot join
- Contraindication for nicotine patch use.
- Active substance abuse or dependence.
- Regular use of tobacco products other than cigarettes (cigars, pipes, smokeless).
- Use of bupropion or nicotine products other than the nicotine patches supplied by the study.
- Pregnancy or lactation.
- Another household member enrolled in the study.
- Participation in a smoking cessation program or study during the past 90 days.
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
Official title: Health Communications and Risk Processing Among Smokers
The goal of this behavioral research study is to put together and study a treatment for nicotine dependence that looks at how participant's thoughts and feelings about smoking may be related to how successfully they quit smoking.
Read the detailed description
If patient agrees to participate, they will receive free treatment to help them quit smoking, including written self-help materials, counseling, and a supply of the nicotine patch for 4 weeks. Participant 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, participant will be asked about their feelings and moods, as well as their smoking status. Participant 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, participant 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 participant inhales. Participant will also complete two computer-based tasks. Women who are pregnant should not take part in this study.
In addition, participant will receive a palmtop personal computer and be trained in how to use it. Participant will carry this small computer with them from the time of their first visit until their last study visit. Participant will use the computer to answer questions about their mood, stress, and smoking-related issues. Participant will be asked to fill out some questions on the computer each time they have an urge to smoke or they actually smoke. Also, the computer will "beep" at random and set times and request that participant answers some questions.
Participant will return for 4 visits after the orientation session. During these visits, participant will receive brief individual counseling where they will discuss techniques to help them quit smoking. Participant will also be asked to fill out questionnaires on a computer about their moods and feelings, as well as their smoking status. The questionnaires should take about 30 minutes to complete. The breath test will be given at every clinic visit.
Participant may be contacted by mail, telephone, and/or e-mail throughout the study and follow-up period, to provide reminders of clinic visits. Participant may also be asked for information about their smoking status during the usual reminder calls and/or calls to reschedule missed appointments.
A supply of the nicotine patch will be provided to participant 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.
- Conditions
- Smoking
- Being tested
- Nicotine Replacement Therapy, Questionnaire
- Keywords
- Risk Perception, Smoking Cessation, Nicotine Replacement Therapy, Questionnaire, Nicotine
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine Replacement TherapyDrug
4 Weeks of nicotine patch. Patch therapy for participants who smoke >10 cigarettes/day consists of 2 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day consists of 2 weeks of 14 mg patches and 2 weeks of 7 mg patches.
QuestionnaireBehavioural
Survey taking 1 and 1/2 hours at each study visit.
| Study group | Role | What they receive |
|---|---|---|
| Smoking Cessation | Treatment to help quit smoking, including written self-help materials, counseling, and 4 week supply of nicotine patch plus 5 MD Anderson Visits. Receives: Drug: Nicotine Replacement Therapy; Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk Perceptions Over Time Among Smokers and Non Smokers
Primary hypothesis is that abstainers will show higher risk perceptions than relapsers.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2006 (estimated)
- Study start10 Feb 2006
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Lorna H. McNeill, PHD, MPH, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00384696
- Sponsor's protocol ID
- 2004-0806
- Other IDs
- 1 K01 CD000193-01
- Status last verified
- May 2019
- First submitted
- 4 Oct 2006
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Communications and Risk Processing Among Smokers
- ClinicalTrials.gov ID
- NCT00384696
- Acronym / sponsor ID
- 2004-0806
- Conditions
- Smoking
- Keywords
- Risk Perception, Smoking Cessation, Nicotine Replacement Therapy, Questionnaire, Nicotine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 10 Feb 2006 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 6 Oct 2006 (estimated)
- Results
- Not posted in the source record
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 behavioral research study is to put together and study a treatment for nicotine dependence that looks at how participant's thoughts and feelings about smoking may be related to how successfully they quit smoking.
Detailed description
If patient agrees to participate, they will receive free treatment to help them quit smoking, including written self-help materials, counseling, and a supply of the nicotine patch for 4 weeks. Participant 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, participant will be asked about their feelings and moods, as well as their smoking status. Participant 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, participant 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 participant inhales. Participant will also complete two computer-based tasks. Women who are pregnant should not take part in this study.
In addition, participant will receive a palmtop personal computer and be trained in how to use it. Participant will carry this small computer with them from the time of their first visit until their last study visit. Participant will use the computer to answer questions about their mood, stress, and smoking-related issues. Participant will be asked to fill out some questions on the computer each time they have an urge to smoke or they actually smoke. Also, the computer will "beep" at random and set times and request that participant answers some questions.
Participant will return for 4 visits after the orientation session. During these visits, participant will receive brief individual counseling where they will discuss techniques to help them quit smoking. Participant will also be asked to fill out questionnaires on a computer about their moods and feelings, as well as their smoking status. The questionnaires should take about 30 minutes to complete. The breath test will be given at every clinic visit.
Participant may be contacted by mail, telephone, and/or e-mail throughout the study and follow-up period, to provide reminders of clinic visits. Participant may also be asked for information about their smoking status during the usual reminder calls and/or calls to reschedule missed appointments.
A supply of the nicotine patch will be provided to participant 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smoking Cessation | – | Drug: Nicotine Replacement Therapy, Behavioral: QuestionnaireTreatment to help quit smoking, including written self-help materials, counseling, and 4 week supply of nicotine patch plus 5 MD Anderson Visits. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Current smoker, age 18 to 65 years, with history of 5 cigarettes/day for last year wishing to quit
Key inclusion criteria (5 listed)
- Age 18 to 65 years.
- Current smoker with a history of at least 5 cigarettes/day for the last year
- Motivated to quit within the next week.
- Home address and a functioning home telephone number.
- Can speak, read, and write in English at a sixth-grade literacy level.
Key exclusion criteria (7 listed)
- Contraindication for nicotine patch use.
- Active substance abuse or dependence.
- Regular use of tobacco products other than cigarettes (cigars, pipes, smokeless).
- Use of bupropion or nicotine products other than the nicotine patches supplied by the study.
- Pregnancy or lactation.
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 Therapy4 Weeks of nicotine patch. Patch therapy for participants who smoke >10 cigarettes/day consists of 2 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day consists of 2 weeks of 14 mg patches and 2 weeks of 7 mg patches. | Drug | Smoking Cessation |
| QuestionnaireSurvey taking 1 and 1/2 hours at each study visit. | Behavioural | Smoking Cessation |
Primary outcome
Risk Perceptions Over Time Among Smokers and Non Smokers
Time frame: 4 weeks
Primary hypothesis is that abstainers will show higher risk perceptions than relapsers.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2019.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Lorna H. McNeill, PHD, MPH 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?
An observational study of Smoking, 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 24 May 2019. 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?
Results are not available in the source record.
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?
Risk Perceptions Over Time Among Smokers and Non Smokers (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2019.