Tobacco Use DisorderMBRPNCT02327104
Effectiveness of Mindfulness Based Relapse Prevention for Tobacco Dependents
A study testing Mindfulness Based Relapse Prevention and Brazilian Ministry of Health Protocol in people with Tobacco Use Disorder, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The dependence on tobacco is a predictable leading cause of death. The treatment based on the cognitive-behavioral therapy, including relapse prevention, became standard for tobacco dependents; yet scientific advances are still needed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Mindfulness Based Relapse Prevention and Brazilian Ministry of Health Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2012to Aug 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of nicotine dependence;
- Patients currently smoking at least 10 cigarettes a day;
- Do not have any current major psychological disorders;
- Patients undergoing treatment for the first time
- Be willing to attend treatment and follow-up sessions, complete surveys and expired CO tests;
- Do not exhibit dependence on other drugs.
Who cannot join
- Dependence on other substances;
- Psychiatric comorbidities;
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Drug Dependency Unit of the Federal University of São Paulo
São Paulo, 04024-003
About this study
Official title: Evaluation of the Effectiveness of the Program of Mindfulness - Based Relapse Prevention (MBRP) as an Assistant Strategy to the Treatment of Tobacco Dependence
The dependence on tobacco is a predictable leading cause of death. The treatment based on the cognitive-behavioral therapy, including relapse prevention, became standard for tobacco dependents; yet scientific advances are still needed. Accordingly, the Mindfulness-Based Relapse Prevention (MBRP) program, adjunct to treatment, has shown promising results. The purpose of this project is to evaluate the effectiveness of the program MBRP as an adjunct in the treatment of smoking cessation instituted by the Ministry of Health, through the Instituto Nacional do Câncer (INCA) in Brazil.There will be a randomized clinical trial, with a simple random allocation. 60 patients will participate in this study receiving treatment (INCA'S standard) randomized between two groups: the MBRP Group (EG), which will undergo eight sessions of MBRP; and the Control Group (CG) that will undergo eight sessions of the traditional model of Relapse Prevention.This study will be conducted at Ambulatory benchmark to smoking cessation treatment in the city of Juiz de Fora (Minas Gerais State- Brazil). Changes will be evaluated on several variables such as cessation of smoking, anxiety, depression, craving, positive and negative affects and will investigate the association of levels of mindfulness with smoking cessation. The data will be assessed at baseline (T0) and four other times: 1 (T1), 3 (T2), 6 (T3) and 12 months (T4) after the initiation of the study, besides being subjected to evaluations of regularly planned maintenance in the protocol of Ministry of Health. For data analysis there will be used Analysis of Variance with Repeated Measures and Longitudinal Logistic Regression, in order to evaluate the effect of two types of intervention on the evolution of comorbidities and abstinence of patients.
Read the detailed description
Treatments based on cognitive-behavioral therapy, including relapse prevention, have become standard for smoking cessation in Brazil and many other areas of the world; yet scientific advances are still needed.
Mindfulness-based approaches have more recently begun to be assessed and implemented for treatment of addiction. The Mindfulness-Based Relapse Prevention (MBRP) program, which integrates mindfulness practice with cognitive therapy approaches, has shown promising preliminary results in previous studies.
The purpose of the current study is to evaluate the effectiveness of the Mindfulness-Based Relapse Prevention program as an adjunct in the standard smoking cessation treatment instituted by the Ministry of Health in Brazil.
The study is a randomized clinical trial, with 60 patients diagnosed with nicotine dependence. 60 patients will participate in this study receiving treatment (instituted by the Ministry of Health in Brazil, through the Instituto Nacional do Câncer - INCA'S standard) randomized between two groups: the Experimental Group (EG), which will undergo eight sessions of MBRP; and the Control Group (CG) that will undergo eight sessions of the traditional model of Relapse Prevention (INCA's standard). This will include patients diagnosed with nicotine dependence, who have achieved abstinence. Specific Objetctives: Evaluate the difference in the number of patients who continued abstinence of tobacco; Study the effectiveness MBRP in preventing lapses and relapses; Evaluate the effect of MBRP on the craving and its association with smoking cessation; Evaluate the effect of MBRP in positive and negative affects and its association with smoking cessation; To investigate the association of levels of mindfulness with smoking cessation; Evaluate the effect of MBRP in depressive symptoms, and its possible association with smoking cessation; Evaluate the effect of MBRP in anxiety symptoms, and its possible association with smoking cessation. These will be assessed at baseline (T0) and four other times: 1 (T1), 3 (T2), 6 (T3) and 12 months (T4) after the initiation of the study, besides being subjected to evaluations of regularly planned maintenance in the protocol INCA. Screening instruments: Self Report Questionnaire (SRQ-20); Questionnaire of Smoking Urges (QSU); Hospital Anxiety and Depression Scale (HAD); Center for Epidemiologic Studies Depression Scale (CES-D); Five Facet Mindfulness Questionnaire (FFMQ); Smokerlyser (measuring CO); The Fagerstrom Test for Nicotine Dependence (FTND); Positive and Negative Affect Schedule (PANAS). For data analysis there will be used Analysis of Variance with Repeated Measures and Longitudinal Logistic Regression, in order to evaluate the effect of two types of intervention on the evolution of comorbidities and abstinence of patients. Context: Ambulatory benchmark to smoking cessation treatment in the city of Juiz de Fora, Minas Gerais, Brazil. Participants: • Inclusion: patients with a diagnosis of nicotine dependence;• Exclusion: dependence on other substances, psychiatric comorbidities, pregnant women. •Groups matched for gender, education level and dependence on tobacco level. This initial study will evaluate the feasibility of Mindfulness-Based Relapse Prevention in the context of the Brazilian Public Health system as a supplemental treatment on craving and smoking cessation.
- Conditions
- Tobacco Use Disorder
- Being tested
- Mindfulness Based Relapse Prevention, Brazilian Ministry of Health Protocol
- Keywords
- mindfulness, tobacco dependence, relapse prevention
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Relapse PreventionBehavioural
The MBRP is an adjuvant treatment for people that have been treated for drug use related problems, and to prevent relapses.
Brazilian Ministry of Health ProtocolOther
The control group will receive maintenance sessions based on the Ministry of Health protocol after the four sessions of cognitive-behavioral approach.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Based Relapse Prevention | Experimental | The Experimental Group (EG) will undergo eight sessions of MBRP after Brazilian Ministry of Health Protocol (BMHP) for Tobacco dependence treatment. MBRP Program: the first three sessions: focus on practicing mindful awareness and integrating mindfulness practices into daily life (body scan, sitting meditation, walking meditation); The next three sessions: emphasize acceptance of present experience and application of mindfulness practices to relapse prevention; The final two sessions: expand to include issues of self-care, support network, and lifestyle balance. Receives: Behavioral: Mindfulness Based Relapse Prevention |
| Brazilian Ministry of Health Protocol | Other | The Control Group (CG) is undergo the protocol of the Brazilian Ministry of Health Protocol (BMHP): clinical evaluation, four sessions of cognitive-behavioral approach and Nicotine Replacement Therapy and/or Bupropion as needed, as the Experimental Group. And during the eight sessions of MBRP (EG) both groups (EG and CG) are subjected to eight maintenance sessions of BMHP. Receives: Behavioral: Mindfulness Based Relapse Prevention; Other: Brazilian Ministry of Health Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the maintenance of abstinence from Cessation of tobacco use through assessment interviews (self-report and CO monitor will be used), and the point prevalence
We will assess the maintenance of abstinence from tobacco use through assessment interviews (self-report and CO monitor will be used), and the point prevalence will be the primary outcome measure.
Measured: baseline and twelve months
Secondary outcomes (7)
Change in smoking urges measured with the self report questionnaire: Questionnaire of Smoking Urges (QSU)
This will be measured with the self report questionnaire: Questionnaire of Smoking Urges (QSU)
Measured: baseline and twelve months
Change in Symptoms of Anxiety measured through the The Hospital Anxiety and Depression Scale (HAD)
The symptoms of anxiety will be measured through the The Hospital Anxiety and Depression Scale (HAD)
Measured: baseline and twelve months
Change in Symptoms of Depression measured through the Centre for Epidemiologic Studies Depression Scale (CES-D)
The symptoms of depression will be measured through the Centre for Epidemiologic Studies Depression Scale (CES-D)
Measured: baseline and twelve months
change in Self report Mindfulness level measured with the self report questionnaire Five Facet Mindfulness Questionnaire (FFMQ)
This will be measured with the self report questionnaire Five Facet Mindfulness Questionnaire (FFMQ)
Measured: baseline and twelve months
Maintenance of Abstinence measured by a Bedfont Micro Smokerlyser - CO monitor
Abstinence will be measured by a Bedfont Micro Smokerlyser - CO monitor, to support self-reports of smoking cessation.
Measured: baseline and twelve months.
Tobacco Dependence measured through The Fagerstrom Test for Nicotine Dependence (FTND)
This will be measured through The Fagerstrom Test for Nicotine Dependence (FTND)
Measured: baseline and twelve months
Change in Positive and Negative Affects measured through Positive and Negative Affect Scale (PANAS)
This will be measured through Positive and Negative Affect Scale (PANAS).
Measured: baseline and twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2014 (estimated)
- Study startOct 2012
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Ana Regina Noto, Federal University of São Paulo
- Investigators
- Ana Regina Noto, Doctor, Study director, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02327104
- Sponsor's protocol ID
- PROCESSO FAPESP 2013/02316-5
- Acronym
- MBRP
- Status last verified
- Jul 2020
- First submitted
- 21 Dec 2014
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2.
PubMed 35420700Weiss de Souza IC, Kozasa EH, Bowen S, Richter KP, Sartes LMA, Colugnati FAB, Noto AR. Effectiveness of Mindfulness-Based Relapse Prevention Program as an Adjunct to the Standard Treatment for Smoking: A Pragmatic Design Pilot Study. Nicotine Tob Res. 2020 Aug 24;22(9):1605-1613. doi: 10.1093/ntr/ntaa057.
PubMed 32222767
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of the Program of Mindfulness - Based Relapse Prevention (MBRP) as an Assistant Strategy to the Treatment of Tobacco Dependence
- ClinicalTrials.gov ID
- NCT02327104
- Acronym / sponsor ID
- MBRP / PROCESSO FAPESP 2013/02316-5
- Conditions
- Tobacco Use Disorder
- Keywords
- mindfulness, tobacco dependence, relapse prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Oct 2012
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 30 Dec 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 dependence on tobacco is a predictable leading cause of death. The treatment based on the cognitive-behavioral therapy, including relapse prevention, became standard for tobacco dependents; yet scientific advances are still needed. Accordingly, the Mindfulness-Based Relapse Prevention (MBRP) program, adjunct to treatment, has shown promising results. The purpose of this project is to evaluate the effectiveness of the program MBRP as an adjunct in the treatment of smoking cessation instituted by the Ministry of Health, through the Instituto Nacional do Câncer (INCA) in Brazil.There will be a randomized clinical trial, with a simple random allocation. 60 patients will participate in this study receiving treatment (INCA'S standard) randomized between two groups: the MBRP Group (EG), which will undergo eight sessions of MBRP; and the Control Group (CG) that will undergo eight sessions of the traditional model of Relapse Prevention.This study will be conducted at Ambulatory benchmark to smoking cessation treatment in the city of Juiz de Fora (Minas Gerais State- Brazil). Changes will be evaluated on several variables such as cessation of smoking, anxiety, depression, craving, positive and negative affects and will investigate the association of levels of mindfulness with smoking cessation. The data will be assessed at baseline (T0) and four other times: 1 (T1), 3 (T2), 6 (T3) and 12 months (T4) after the initiation of the study, besides being subjected to evaluations of regularly planned maintenance in the protocol of Ministry of Health. For data analysis there will be used Analysis of Variance with Repeated Measures and Longitudinal Logistic Regression, in order to evaluate the effect of two types of intervention on the evolution of comorbidities and abstinence of patients.
Detailed description
Treatments based on cognitive-behavioral therapy, including relapse prevention, have become standard for smoking cessation in Brazil and many other areas of the world; yet scientific advances are still needed.
Mindfulness-based approaches have more recently begun to be assessed and implemented for treatment of addiction. The Mindfulness-Based Relapse Prevention (MBRP) program, which integrates mindfulness practice with cognitive therapy approaches, has shown promising preliminary results in previous studies.
The purpose of the current study is to evaluate the effectiveness of the Mindfulness-Based Relapse Prevention program as an adjunct in the standard smoking cessation treatment instituted by the Ministry of Health in Brazil.
The study is a randomized clinical trial, with 60 patients diagnosed with nicotine dependence. 60 patients will participate in this study receiving treatment (instituted by the Ministry of Health in Brazil, through the Instituto Nacional do Câncer - INCA'S standard) randomized between two groups: the Experimental Group (EG), which will undergo eight sessions of MBRP; and the Control Group (CG) that will undergo eight sessions of the traditional model of Relapse Prevention (INCA's standard). This will include patients diagnosed with nicotine dependence, who have achieved abstinence. Specific Objetctives: Evaluate the difference in the number of patients who continued abstinence of tobacco; Study the effectiveness MBRP in preventing lapses and relapses; Evaluate the effect of MBRP on the craving and its association with smoking cessation; Evaluate the effect of MBRP in positive and negative affects and its association with smoking cessation; To investigate the association of levels of mindfulness with smoking cessation; Evaluate the effect of MBRP in depressive symptoms, and its possible association with smoking cessation; Evaluate the effect of MBRP in anxiety symptoms, and its possible association with smoking cessation. These will be assessed at baseline (T0) and four other times: 1 (T1), 3 (T2), 6 (T3) and 12 months (T4) after the initiation of the study, besides being subjected to evaluations of regularly planned maintenance in the protocol INCA. Screening instruments: Self Report Questionnaire (SRQ-20); Questionnaire of Smoking Urges (QSU); Hospital Anxiety and Depression Scale (HAD); Center for Epidemiologic Studies Depression Scale (CES-D); Five Facet Mindfulness Questionnaire (FFMQ); Smokerlyser (measuring CO); The Fagerstrom Test for Nicotine Dependence (FTND); Positive and Negative Affect Schedule (PANAS). For data analysis there will be used Analysis of Variance with Repeated Measures and Longitudinal Logistic Regression, in order to evaluate the effect of two types of intervention on the evolution of comorbidities and abstinence of patients. Context: Ambulatory benchmark to smoking cessation treatment in the city of Juiz de Fora, Minas Gerais, Brazil. Participants: • Inclusion: patients with a diagnosis of nicotine dependence;• Exclusion: dependence on other substances, psychiatric comorbidities, pregnant women. •Groups matched for gender, education level and dependence on tobacco level. This initial study will evaluate the feasibility of Mindfulness-Based Relapse Prevention in the context of the Brazilian Public Health system as a supplemental treatment on craving and smoking cessation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Based Relapse Prevention | Experimental | Behavioral: Mindfulness Based Relapse PreventionThe Experimental Group (EG) will undergo eight sessions of MBRP after Brazilian Ministry of Health Protocol (BMHP) for Tobacco dependence treatment. MBRP Program: the first three sessions: focus on practicing mindful awareness and integrating mindfulness practices into daily life (body scan, sitting meditation, walking meditation); The next three sessions: emphasize acceptance of present experience and application of mindfulness practices to relapse prevention; The final two sessions: expand to include issues of self-care, support network, and lifestyle balance. |
| Brazilian Ministry of Health Protocol | Other | Behavioral: Mindfulness Based Relapse Prevention, Other: Brazilian Ministry of Health ProtocolThe Control Group (CG) is undergo the protocol of the Brazilian Ministry of Health Protocol (BMHP): clinical evaluation, four sessions of cognitive-behavioral approach and Nicotine Replacement Therapy and/or Bupropion as needed, as the Experimental Group. And during the eight sessions of MBRP (EG) both groups (EG and CG) are subjected to eight maintenance sessions of BMHP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with a diagnosis of nicotine dependence;
- Patients currently smoking at least 10 cigarettes a day;
- Do not have any current major psychological disorders;
- Patients undergoing treatment for the first time
- Be willing to attend treatment and follow-up sessions, complete surveys and expired CO tests;
Key exclusion criteria (3 listed)
- Dependence on other substances;
- Psychiatric comorbidities;
- Pregnant women.
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 |
|---|---|---|
| Mindfulness Based Relapse PreventionThe MBRP is an adjuvant treatment for people that have been treated for drug use related problems, and to prevent relapses. | Behavioural | Brazilian Ministry of Health Protocol, Mindfulness Based Relapse Prevention |
| Brazilian Ministry of Health ProtocolThe control group will receive maintenance sessions based on the Ministry of Health protocol after the four sessions of cognitive-behavioral approach. | Other | Brazilian Ministry of Health Protocol |
Primary outcome
Change in the maintenance of abstinence from Cessation of tobacco use through assessment interviews (self-report and CO monitor will be used), and the point prevalence
Time frame: baseline and twelve months
We will assess the maintenance of abstinence from tobacco use through assessment interviews (self-report and CO monitor will be used), and the point prevalence will be the primary outcome measure.
7 secondary outcomes
Change in smoking urges measured with the self report questionnaire: Questionnaire of Smoking Urges (QSU)
Time frame: baseline and twelve months
Change in Symptoms of Anxiety measured through the The Hospital Anxiety and Depression Scale (HAD)
Time frame: baseline and twelve months
Change in Symptoms of Depression measured through the Centre for Epidemiologic Studies Depression Scale (CES-D)
Time frame: baseline and twelve months
change in Self report Mindfulness level measured with the self report questionnaire Five Facet Mindfulness Questionnaire (FFMQ)
Time frame: baseline and twelve months
Maintenance of Abstinence measured by a Bedfont Micro Smokerlyser - CO monitor
Time frame: baseline and twelve months.
Tobacco Dependence measured through The Fagerstrom Test for Nicotine Dependence (FTND)
Time frame: baseline and twelve months
Change in Positive and Negative Affects measured through Positive and Negative Affect Scale (PANAS)
Time frame: baseline and twelve months
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 27 Jul 2020.
- Derived from this study: PubMed 35420700Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2.
- Derived from this study: PubMed 32222767Weiss de Souza IC, Kozasa EH, Bowen S, Richter KP, Sartes LMA, Colugnati FAB, Noto AR. Effectiveness of Mindfulness-Based Relapse Prevention Program as an Adjunct to the Standard Treatment for Smoking: A Pragmatic Design Pilot Study. Nicotine Tob Res. 2020 Aug 24;22(9):1605-1613. doi: 10.1093/ntr/ntaa057.
- Individual participant dataSharing planned: Undecided
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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.
Ana Regina Noto, Doctor study director
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Relapse Prevention and Brazilian Ministry of Health Protocol in people with Tobacco Use Disorder, run by Federal University of São Paulo at 1 site in Brazil.
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 6 inclusion and 3 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 27 Jul 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 Brazil. 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?
Change in the maintenance of abstinence from Cessation of tobacco use through assessment interviews (self-report and CO monitor will be used), and the point prevalence (time frame: baseline and twelve 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 NCT02327104, which also lists 2 linked publications.
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 27 Jul 2020.