Smoking CessationNCT00984724
Reducing Tobacco Related Health Disparities
A study testing Standard Treatment (ST), Telephone Counseling and Quitline in people with Smoking Cessation and Smoking, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this research study is to learn the effectiveness of telephone-based counseling on helping smokers change their smoking patterns. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Smoking
- What is being tested?
- Standard Treatment (ST), Telephone Counseling and Quitline
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 639 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Sep 2016
- 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
- HCHD Patient or is at or below 200% of the poverty guideline
- 18 years of age or older
- Current smoker
- History of at least one cigarette per day for the past year
- Not ready to quit in the next 30 days
- Valid home address
Show all 9Show fewer
- Functioning telephone number
- Can speak, read, and understand English
- Register "5" or more on a carbon monoxide breath test
Who cannot join
- Other household members enrolled in this study
- Enrolled in any other smoking study during the past 90 days
- Scores below the 6th grade literacy level on the Rapid Estimate of Adult Literacy in Medicine (REALM)
- Regular use of tobacco products other than cigarettes
- Pregnancy or lactation
- Active substance dependence (exclusive of nicotine dependence)
- Use of bupropion or nicotine products
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 research study is to learn the effectiveness of telephone-based counseling on helping smokers change their smoking patterns.
Read the detailed description
Researchers want to learn if telephone counseling can help smokers change their smoking patterns, when combined with other interventions.
Study Groups:
During the first (baseline) visit, you will be randomly assigned (as in a throw of the dice) to 1 of 4 study groups. The first group will receive free self-help materials, and a referral to the Quitline. The Quitline provides free quit smoking services to eligible callers. The second group will receive free self-help materials, a referral to the Quitline, and 300 pieces of nicotine gum at baseline. The third group will receive free self-help materials, a referral to the Quitline, and 4 telephone counseling sessions over the next month. The fourth group will receive free self-help materials, a referral to the Quitline, 4 telephone counseling sessions over the next month, and 300 pieces of nicotine gum at baseline.
Study Visits:
If you choose to take part in this study, you will visit MD Anderson twice. Your first visit is the "baseline" visit when you enter the study and your final visit is the "follow-up" visit, which is 1 month after baseline.
Study Tests:
The following tests and procedures will be performed at the study visits:
- You will be asked to complete some questionnaires that will include questions about your feelings, moods, and smoking status. These will take 60 to 90 minutes to complete.
- You will have your height, weight, and waistline measured.
- You will complete a breath test to help estimate (guess) the amount of cigarette smoke you inhale. The breath test uses a disposable cardboard tube that is attached to the machine, and you blow a long, slow, steady breath into it.
- You will have saliva samples collected for cotinine tests. To collect the saliva, you will be asked to put a small piece of cotton in your mouth for a few minutes. These samples will be used to measure the amount of cotinine in your saliva. Cotinine is a chemical released in your body when it breaks down nicotine.
All participants will be contacted by mail or telephone throughout the length of the study. You may be contacted by mail, telephone, and/or e-mail during the study and follow-up, to be given reminders of clinic visits. You will be asked to provide the names and contact information for family and/or friends for the study staff to contact if the study staff has trouble reaching you.
Genetic Testing:
As part of this study, you will be asked to provide a saliva sample that will be collected at the first visit. To collect the saliva sample, you will be 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. The saliva sample will be stored in a biorepository at MD 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 MD 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.
Telephone Counseling:
The telephone counseling sessions will be digitally recorded. The recordings, if not destroyed, may be kept for use in future research studies. The recordings will be used to help the researchers make sure that the counselors are following the correct procedures and may be used in the future to help the investigators better understand or improve the counseling treatment. No one but the study investigators and their staff will be allowed to view or listen to the recordings, and the identity of the participants will be kept strictly confidential. Your study identification number will be stated by the counselor at the beginning of the taped session. The recordings are stored digitally, encrypted, and password protected.
This is an investigational study. The nicotine gum used in this study is approved by the FDA. Up to 100 smokers will take part in this research study. All will be enrolled at MD Anderson.
- Conditions
- Smoking Cessation, Smoking
- Being tested
- Standard Treatment (ST), Telephone Counseling, Quitline, Nicotine Replacement Therapy (NRT)
- Keywords
- Smoking, Motivation and Problem Solving, MAPS, Low Income Smokers, HCHD community clinics, Telephone-based counseling
- 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.
Standard Treatment (ST)Behavioural
Mailing of packet of materials including a letter referring smokers to the Texas Quitline, nicotine replacement therapy when participants are ready to quit and standard self-help materials; ST delivered a total of 4 times (at Baseline, 6, 12, and 18 months).
Telephone CounselingBehavioural
MAPS-6: 6 MAPS proactive telephone counseling sessions delivered over a 2-year period
MAPS-12: 12 MAPS proactive telephone counseling sessions over a 2-year period
QuitlineBehavioural
Letter referring participants to a Quitline providing quit smoking services.
Nicotine Replacement Therapy (NRT)Behavioural
300 pieces of nicotine gum issued at baseline visit.
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment | Experimental | Standard Treatment (ST): Mailed Packet with standard self-help materials; ST delivered a total of 4 times (at Baseline, 6, 12, and 18 months). Referral to Quitline. Receives: Behavioral: Standard Treatment (ST); Behavioral: Quitline |
| MAPS-6 | Experimental | Standard Treatment (ST) plus 6 proactive telephone counseling sessions; ST delivered 4 times (at Baseline, 6, 12, and 18 months). 6 MAPS proactive telephone counseling sessions over 2-year period. Receives: Behavioral: Standard Treatment (ST); Behavioral: Telephone Counseling; Behavioral: Quitline |
| MAPS-12 | Experimental | Standard Treatment (ST) plus 12 proactive telephone counseling sessions; ST delivered 4 times (at Baseline, 6, 12, and 18 months). 12 MAPS proactive telephone counseling sessions over 2-year period. Referral to Quitline. Receives: Behavioral: Standard Treatment (ST); Behavioral: Telephone Counseling; Behavioral: Quitline |
| Standard Treatment + NRT | Experimental | Standard Treatment (ST): Mailed Packet with standard self-help materials; ST delivered a total of 4 times (at Baseline, 6, 12, and 18 months). Nicotine replacement therapy (NRT) consisting of 300 pieces of nicotine gum issued at baseline visit. Receives: Behavioral: Standard Treatment (ST); Behavioral: Quitline; Behavioral: Nicotine Replacement Therapy (NRT) |
| MAPS-6 + NRT | Experimental | Standard Treatment (ST) plus 6 proactive telephone counseling sessions; delivered 4 times (at Baseline, 6, 12, and 18 months). 6 MAPS proactive telephone counseling sessions over 2-year period. Referral to Quitline. Nicotine replacement therapy (NRT) consisting of 300 pieces of nicotine gum issued at baseline visit. Receives: Behavioral: Standard Treatment (ST); Behavioral: Telephone Counseling; Behavioral: Quitline; Behavioral: Nicotine Replacement Therapy (NRT) |
| MAPS-12 + NRT | Experimental | Standard Treatment (ST) plus 12 proactive telephone counseling sessions; ST delivered 4 times (at Baseline, 6, 12, and 18 months). 12 MAPS proactive telephone counseling sessions over 2-year period. Referral to Quitline. Nicotine replacement therapy (NRT) consisting of 300 pieces of nicotine gum issued at baseline visit. Receives: Behavioral: Standard Treatment (ST); Behavioral: Telephone Counseling; Behavioral: Quitline; Behavioral: Nicotine Replacement Therapy (NRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Tobacco Abstinence
Prolonged abstinence refers to abstinence beginning with initiation of the intervention and including a grace period. Prolonged abstinence measure utilizes the Society for Research on Nicotine and Tobacco's recommendation for determining relapse (i.e., 7 consecutive days of smoking or smoking in each of 2 consecutive weeks). Abstinence at all follow-ups will be biochemically verified using a carbon monoxide level of <10ppm. Saliva samples collected for cotinine tests at the baseline and 24 month follow-up visits. Saliva samples analyzed for cotinine, a metabolic byproduct of nicotine that provides an estimate of nicotine consumption. A saliva cotinine level of <20 ng/ml considered as abstinent.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study startJan 2011
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 639 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Larkin L. Strong, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984724
- Sponsor's protocol ID
- 2009-0372
- Other IDs
- 1R01CA141613-01, NCI-2011-00289
- Status last verified
- Oct 2016
- First submitted
- 23 Sep 2009
- Last updated
- 7 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Theodoulou A, Chepkin SC, Ye W, Fanshawe TR, Bullen C, Hartmann-Boyce J, Livingstone-Banks J, Hajizadeh A, Lindson N. Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2023 Jun 19;6(6):CD013308. doi: 10.1002/14651858.CD013308.pub2.
PubMed 37335995
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Tobacco Related Health Disparities
- ClinicalTrials.gov ID
- NCT00984724
- Acronym / sponsor ID
- 2009-0372
- Conditions
- Smoking Cessation, Smoking
- Keywords
- Smoking, Motivation and Problem Solving, MAPS, Low Income Smokers, HCHD community clinics, Telephone-based counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 639 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2011
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 25 Sep 2009 (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 learn the effectiveness of telephone-based counseling on helping smokers change their smoking patterns.
Detailed description
Researchers want to learn if telephone counseling can help smokers change their smoking patterns, when combined with other interventions.
Study Groups:
During the first (baseline) visit, you will be randomly assigned (as in a throw of the dice) to 1 of 4 study groups. The first group will receive free self-help materials, and a referral to the Quitline. The Quitline provides free quit smoking services to eligible callers. The second group will receive free self-help materials, a referral to the Quitline, and 300 pieces of nicotine gum at baseline. The third group will receive free self-help materials, a referral to the Quitline, and 4 telephone counseling sessions over the next month. The fourth group will receive free self-help materials, a referral to the Quitline, 4 telephone counseling sessions over the next month, and 300 pieces of nicotine gum at baseline.
Study Visits:
If you choose to take part in this study, you will visit MD Anderson twice. Your first visit is the "baseline" visit when you enter the study and your final visit is the "follow-up" visit, which is 1 month after baseline.
Study Tests:
The following tests and procedures will be performed at the study visits:
- You will be asked to complete some questionnaires that will include questions about your feelings, moods, and smoking status. These will take 60 to 90 minutes to complete.
- You will have your height, weight, and waistline measured.
- You will complete a breath test to help estimate (guess) the amount of cigarette smoke you inhale. The breath test uses a disposable cardboard tube that is attached to the machine, and you blow a long, slow, steady breath into it.
- You will have saliva samples collected for cotinine tests. To collect the saliva, you will be asked to put a small piece of cotton in your mouth for a few minutes. These samples will be used to measure the amount of cotinine in your saliva. Cotinine is a chemical released in your body when it breaks down nicotine.
All participants will be contacted by mail or telephone throughout the length of the study. You may be contacted by mail, telephone, and/or e-mail during the study and follow-up, to be given reminders of clinic visits. You will be asked to provide the names and contact information for family and/or friends for the study staff to contact if the study staff has trouble reaching you.
Genetic Testing:
As part of this study, you will be asked to provide a saliva sample that will be collected at the first visit. To collect the saliva sample, you will be 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. The saliva sample will be stored in a biorepository at MD 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 MD 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.
Telephone Counseling:
The telephone counseling sessions will be digitally recorded. The recordings, if not destroyed, may be kept for use in future research studies. The recordings will be used to help the researchers make sure that the counselors are following the correct procedures and may be used in the future to help the investigators better understand or improve the counseling treatment. No one but the study investigators and their staff will be allowed to view or listen to the recordings, and the identity of the participants will be kept strictly confidential. Your study identification number will be stated by the counselor at the beginning of the taped session. The recordings are stored digitally, encrypted, and password protected.
This is an investigational study. The nicotine gum used in this study is approved by the FDA. Up to 100 smokers will take part in this research study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment | Experimental | Behavioral: Standard Treatment (ST), Behavioral: QuitlineStandard Treatment (ST): Mailed Packet with standard self-help materials; ST delivered a total of 4 times (at Baseline, 6, 12, and 18 months). Referral to Quitline. |
| MAPS-6 | Experimental | Behavioral: Standard Treatment (ST), Behavioral: Telephone Counseling, Behavioral: QuitlineStandard Treatment (ST) plus 6 proactive telephone counseling sessions; ST delivered 4 times (at Baseline, 6, 12, and 18 months). 6 MAPS proactive telephone counseling sessions over 2-year period. |
| MAPS-12 | Experimental | Behavioral: Standard Treatment (ST), Behavioral: Telephone Counseling, Behavioral: QuitlineStandard Treatment (ST) plus 12 proactive telephone counseling sessions; ST delivered 4 times (at Baseline, 6, 12, and 18 months). 12 MAPS proactive telephone counseling sessions over 2-year period. Referral to Quitline. |
| Standard Treatment + NRT | Experimental | Behavioral: Standard Treatment (ST), Behavioral: Quitline, Behavioral: Nicotine Replacement Therapy (NRT)Standard Treatment (ST): Mailed Packet with standard self-help materials; ST delivered a total of 4 times (at Baseline, 6, 12, and 18 months). Nicotine replacement therapy (NRT) consisting of 300 pieces of nicotine gum issued at baseline visit. |
| MAPS-6 + NRT | Experimental | Behavioral: Standard Treatment (ST), Behavioral: Telephone Counseling, Behavioral: Quitline, Behavioral: Nicotine Replacement Therapy (NRT)Standard Treatment (ST) plus 6 proactive telephone counseling sessions; delivered 4 times (at Baseline, 6, 12, and 18 months). 6 MAPS proactive telephone counseling sessions over 2-year period. Referral to Quitline. Nicotine replacement therapy (NRT) consisting of 300 pieces of nicotine gum issued at baseline visit. |
| MAPS-12 + NRT | Experimental | Behavioral: Standard Treatment (ST), Behavioral: Telephone Counseling, Behavioral: Quitline, Behavioral: Nicotine Replacement Therapy (NRT)Standard Treatment (ST) plus 12 proactive telephone counseling sessions; ST delivered 4 times (at Baseline, 6, 12, and 18 months). 12 MAPS proactive telephone counseling sessions over 2-year period. Referral to Quitline. Nicotine replacement therapy (NRT) consisting of 300 pieces of nicotine gum issued at baseline visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- HCHD Patient or is at or below 200% of the poverty guideline
- 18 years of age or older
- Current smoker
- History of at least one cigarette per day for the past year
- Not ready to quit in the next 30 days
Key exclusion criteria (7 listed)
- Other household members enrolled in this study
- Enrolled in any other smoking study during the past 90 days
- Scores below the 6th grade literacy level on the Rapid Estimate of Adult Literacy in Medicine (REALM)
- Regular use of tobacco products other than cigarettes
- 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 |
|---|---|---|
| Standard Treatment (ST)Mailing of packet of materials including a letter referring smokers to the Texas Quitline, nicotine replacement therapy when participants are ready to quit and standard self-help materials; ST delivered a total of 4 times (at Baseline, 6, 12, and 18 months). | Behavioural | MAPS-12, MAPS-12 + NRT, MAPS-6, MAPS-6 + NRT, Standard Treatment, Standard Treatment + NRT |
| Telephone CounselingMAPS-6: 6 MAPS proactive telephone counseling sessions delivered over a 2-year period MAPS-12: 12 MAPS proactive telephone counseling sessions over a 2-year period | Behavioural | MAPS-12, MAPS-12 + NRT, MAPS-6, MAPS-6 + NRT |
| QuitlineLetter referring participants to a Quitline providing quit smoking services. | Behavioural | MAPS-12, MAPS-12 + NRT, MAPS-6, MAPS-6 + NRT, Standard Treatment, Standard Treatment + NRT |
| Nicotine Replacement Therapy (NRT)300 pieces of nicotine gum issued at baseline visit. | Behavioural | MAPS-12 + NRT, MAPS-6 + NRT, Standard Treatment + NRT |
Primary outcome
Number of Patients with Tobacco Abstinence
Time frame: 24 months
Prolonged abstinence refers to abstinence beginning with initiation of the intervention and including a grace period. Prolonged abstinence measure utilizes the Society for Research on Nicotine and Tobacco's recommendation for determining relapse (i.e., 7 consecutive days of smoking or smoking in each of 2 consecutive weeks). Abstinence at all follow-ups will be biochemically verified using a carbon monoxide level of <10ppm. Saliva samples collected for cotinine tests at the baseline and 24 month follow-up visits. Saliva samples analyzed for cotinine, a metabolic byproduct of nicotine that provides an estimate of nicotine consumption. A saliva cotinine level of <20 ng/ml considered as abstinent.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2016.
- Derived from this study: PubMed 37335995Theodoulou A, Chepkin SC, Ye W, Fanshawe TR, Bullen C, Hartmann-Boyce J, Livingstone-Banks J, Hajizadeh A, Lindson N. Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2023 Jun 19;6(6):CD013308. doi: 10.1002/14651858.CD013308.pub2.
- 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.
Larkin L. Strong, PHD 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 Standard Treatment (ST), Telephone Counseling and Quitline in people with Smoking Cessation and 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 9 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: finished, as of the sponsor's last update on 7 Oct 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Patients with Tobacco Abstinence (time frame: 24 months). 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 NCT00984724, 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 7 Oct 2016.