Tobacco Use CessationNCT02029612
An Evidence Based Smoking Cessation Program for Persons Living With HIV/AIDS (Project Legacy)
A study testing Nicotine Patch, Phone Counseling and Questionnaires in people with Tobacco Use Cessation, run by M.D. Anderson Cancer Center.
Trial summary
The goal of this research study is to compare 2 different phone-based programs for quitting smoking for people with HIV/AIDS. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Cessation
- What is being tested?
- Nicotine Patch, Phone Counseling and Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Apr 2019
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Receiving care for HIV/AIDS at a Legacy Community Health Services Clinic
- 18 years of age or older
- Self-reported current smoker (smoked at least 100 cigarettes in lifetime and smoking every day or most days)
- Able to provide written informed consent to participate
- English or Spanish speaking
Who cannot join
- Positive history of a medical condition that precludes use of the nicotine patch
- Current use of nicotine replacement therapy (NRT)
- Current use of other smoking cessation medications (e.g., Chantix or Zyban)
- Pregnant or nursing
- Enrolled in another smoking cessation study
- Unwilling to set a target quit date
About this study
Official title: An Evidence Based Smoking Cessation Program for Persons Living With HIV/AIDS
The goal of this research study is to compare 2 different phone-based programs for quitting smoking for people with HIV/AIDS.
Read the detailed description
If participant agrees to take part in this study, the following will be done at the first visit (called the Baseline Visit):
- The study staff will give participant advice about quitting smoking. Participant will then set a quit date, after which they will plan to not smoke anymore.
- Participant will receive a 10-week supply of nicotine patches and instructions on how to use them.
- Participant will complete questionnaires on a laptop computer about their smoking habits, how much tobacco they use, how many times they have tried to quit, how ready they are to quit, and how dependent they are on nicotine. The questionnaires will take about 30 minutes to complete.
Participant will then be assigned to 1 of 2 study groups. Participant will have a 1 in 5 (20%) chance of being assigned to Group 1, and a 4 in 5 (80%) chance of being assigned to Group 2.
If participant is in Group 1:
- Participant will receive a telephone number to a hotline for them to use to call and talk to someone about quitting. Participant can call the hotline anytime they need support in their effort to quit smoking.
- Participant will also receive 11 phone calls from the study staff over a 6-month period. During each call, participant will be given support to help them quit. Each call will last about 15 minutes.
If participant is in Group 2:
- Participant will receive text messages for support about quitting smoking. In the first week, participant will get about 20 text messages. Each week, participant will receive fewer text messages, until they get 1 message per week by week 4. Participant will then get 1 message each week after that through month 6.
- Participant will also receive another text message 1 time each week from the study staff asking if they have smoked within the past 24 hours. Participant will be asked to respond to this text message either by sending a text back to the study staff or calling the study staff. If the study staff does not receive participant's response they may receive a phone call from the staff asking about their smoking status over the past 24 hours.
Follow-Up Visits (Both Groups):
Three (3) and 6 months after the Baseline Visit, you will complete questionnaires on a laptop computer and participant will be asked for more information about their smoking status. At this visit, participant will also be asked to blow into a cardboard tube to check for byproducts of smoking. These visits will last about 20 minutes each.
Length of Study:
Participant will be on study for about 6 months.
This is an investigational study.
Up to 1000 patients will take part in this study. All will be enrolled at Legacy Community Health Services Clinic.
- Conditions
- Tobacco Use Cessation
- Being tested
- Nicotine Patch, Phone Counseling, Questionnaires, Breath Test, Proactive Cell Phone Smoking Cessation Counseling
- Keywords
- Tobacco Use Cessation, Cancer Prevention, HIV/AIDS, Questionnaires, Surveys, Nicotine patch, Breath test, Cell Phone Calls for Smoking Cessation Counseling, Text Message Smoking Cessation Support
- Medical subject headings
- Tobacco Use Cessation, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine PatchDrug
10 week supply of nicotine patches given to participants at baseline.
Phone CounselingBehavioural
Each participant counseled on quitting smoking at baseline.
QuestionnairesBehavioural
Also called Surveys
Questionnaires completed at baseline, 3 months, and at 6 months.
Breath TestBehavioural
Breath test performed at 3 month and 6 month visit.
Proactive Cell Phone Smoking Cessation CounselingBehavioural
Participant receives 11 phone calls from study staff over a 6-month period.
Text Message Smoking Cessation SupportBehavioural
Participants receive text messages for support about quitting smoking over a 6 month period.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Phone Call Support | Other | Smoking cessation telephone hotline phone number provided to participants, along with a 10 week supply of nicotine patches. Each participant counseled on quitting smoking at baseline. Questionnaires completed at baseline, 3 months, and at 6 months. Participant receives 11 phone calls from study staff over a 6-month period. Breath test performed at 3 month and 6 month visit. Receives: Drug: Nicotine Patch; Behavioral: Phone Counseling; Behavioral: Questionnaires; Behavioral: Breath Test; Behavioral: Proactive Cell Phone Smoking Cessation Counseling |
| Group 2 - Text Messaging Support | Other | Participants receive 10 week supply of nicotine patches. Each participant counseled on quitting smoking at baseline. Questionnaires completed at baseline, 3 months, and at 6 months. Participants receive text messages for support about quitting smoking over a 6 month period. Breath test performed at 3 month and 6 month visit. Receives: Drug: Nicotine Patch; Behavioral: Phone Counseling; Behavioral: Questionnaires; Behavioral: Breath Test; Behavioral: Text Message Smoking Cessation Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Abstinence
Smoking abstinence defined as biochemically confirmed 7-day abstinence. Expired CO will be used to biochemically verify abstinence.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Medicare and Medicaid Services
- Responsible party
- Sponsor
- Investigators
- Damon Vidrine, MS, DRPH, BA, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029612
- Sponsor's protocol ID
- 2013-0495
- Status last verified
- Feb 2014
- First submitted
- 19 Nov 2013
- Last updated
- 28 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evidence Based Smoking Cessation Program for Persons Living With HIV/AIDS
- ClinicalTrials.gov ID
- NCT02029612
- Acronym / sponsor ID
- 2013-0495
- Conditions
- Tobacco Use Cessation
- Keywords
- Tobacco Use Cessation, Cancer Prevention, HIV/AIDS, Questionnaires, Surveys, Nicotine patch, Breath test, Cell Phone Calls for Smoking Cessation Counseling
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Centers for Medicare and Medicaid Services
- Study start
- Apr 2014
- Primary completion
- Apr 2019 (estimated)
- First posted
- 8 Jan 2014 (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 research study is to compare 2 different phone-based programs for quitting smoking for people with HIV/AIDS.
Detailed description
If participant agrees to take part in this study, the following will be done at the first visit (called the Baseline Visit):
- The study staff will give participant advice about quitting smoking. Participant will then set a quit date, after which they will plan to not smoke anymore.
- Participant will receive a 10-week supply of nicotine patches and instructions on how to use them.
- Participant will complete questionnaires on a laptop computer about their smoking habits, how much tobacco they use, how many times they have tried to quit, how ready they are to quit, and how dependent they are on nicotine. The questionnaires will take about 30 minutes to complete.
Participant will then be assigned to 1 of 2 study groups. Participant will have a 1 in 5 (20%) chance of being assigned to Group 1, and a 4 in 5 (80%) chance of being assigned to Group 2.
If participant is in Group 1:
- Participant will receive a telephone number to a hotline for them to use to call and talk to someone about quitting. Participant can call the hotline anytime they need support in their effort to quit smoking.
- Participant will also receive 11 phone calls from the study staff over a 6-month period. During each call, participant will be given support to help them quit. Each call will last about 15 minutes.
If participant is in Group 2:
- Participant will receive text messages for support about quitting smoking. In the first week, participant will get about 20 text messages. Each week, participant will receive fewer text messages, until they get 1 message per week by week 4. Participant will then get 1 message each week after that through month 6.
- Participant will also receive another text message 1 time each week from the study staff asking if they have smoked within the past 24 hours. Participant will be asked to respond to this text message either by sending a text back to the study staff or calling the study staff. If the study staff does not receive participant's response they may receive a phone call from the staff asking about their smoking status over the past 24 hours.
Follow-Up Visits (Both Groups):
Three (3) and 6 months after the Baseline Visit, you will complete questionnaires on a laptop computer and participant will be asked for more information about their smoking status. At this visit, participant will also be asked to blow into a cardboard tube to check for byproducts of smoking. These visits will last about 20 minutes each.
Length of Study:
Participant will be on study for about 6 months.
This is an investigational study.
Up to 1000 patients will take part in this study. All will be enrolled at Legacy Community Health Services Clinic.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Phone Call Support | Other | Drug: Nicotine Patch, Behavioral: Phone Counseling, Behavioral: Questionnaires, Behavioral: Breath Test, Behavioral: Proactive Cell Phone Smoking Cessation CounselingSmoking cessation telephone hotline phone number provided to participants, along with a 10 week supply of nicotine patches. Each participant counseled on quitting smoking at baseline. Questionnaires completed at baseline, 3 months, and at 6 months. Participant receives 11 phone calls from study staff over a 6-month period. Breath test performed at 3 month and 6 month visit. |
| Group 2 - Text Messaging Support | Other | Drug: Nicotine Patch, Behavioral: Phone Counseling, Behavioral: Questionnaires, Behavioral: Breath Test, Behavioral: Text Message Smoking Cessation SupportParticipants receive 10 week supply of nicotine patches. Each participant counseled on quitting smoking at baseline. Questionnaires completed at baseline, 3 months, and at 6 months. Participants receive text messages for support about quitting smoking over a 6 month period. Breath test performed at 3 month and 6 month visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Receiving care for HIV/AIDS at a Legacy Community Health Services Clinic
- 18 years of age or older
- Self-reported current smoker (smoked at least 100 cigarettes in lifetime and smoking every day or most days)
- Able to provide written informed consent to participate
- English or Spanish speaking
Key exclusion criteria (6 listed)
- Positive history of a medical condition that precludes use of the nicotine patch
- Current use of nicotine replacement therapy (NRT)
- Current use of other smoking cessation medications (e.g., Chantix or Zyban)
- Pregnant or nursing
- Enrolled in another smoking cessation study
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 Patch10 week supply of nicotine patches given to participants at baseline. | Drug | Group 1 - Phone Call Support, Group 2 - Text Messaging Support |
| Phone CounselingEach participant counseled on quitting smoking at baseline. | Behavioural | Group 1 - Phone Call Support, Group 2 - Text Messaging Support |
| QuestionnairesAlso: SurveysQuestionnaires completed at baseline, 3 months, and at 6 months. | Behavioural | Group 1 - Phone Call Support, Group 2 - Text Messaging Support |
| Breath TestBreath test performed at 3 month and 6 month visit. | Behavioural | Group 1 - Phone Call Support, Group 2 - Text Messaging Support |
| Proactive Cell Phone Smoking Cessation CounselingParticipant receives 11 phone calls from study staff over a 6-month period. | Behavioural | Group 1 - Phone Call Support |
| Text Message Smoking Cessation SupportParticipants receive text messages for support about quitting smoking over a 6 month period. | Behavioural | Group 2 - Text Messaging Support |
Primary outcome
Smoking Abstinence
Time frame: 3 months
Smoking abstinence defined as biochemically confirmed 7-day abstinence. Expired CO will be used to biochemically verify abstinence.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2014.
- 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.
Damon Vidrine, MS, DRPH, BA principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine Patch, Phone Counseling and Questionnaires in people with Tobacco Use Cessation, run by M.D. Anderson Cancer Center.
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 6 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: withdrawn, as of the sponsor's last update on 28 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Smoking Abstinence (time frame: 3 months). 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 28 Feb 2014.