Cigarette SmokingNCT02210832
Financial Incentives for Smoking Cessation Among Disadvantaged Pregnant Women
A study testing Best practices and financial incentives in people with Cigarette Smoking, run by University of Vermont at 1 site in United States.
Trial summary
Investigators will examine whether adding financial incentives to current best practices for smoking cessation during pregnancy (i.e., referral to pregnancy-specific counseling using a telephone quit line) increases cessation rates and improves infant health. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- Best practices and financial incentives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2014to 31 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- report being smokers at the time that they learned of the current pregnancy;
- report smoking in the 7 days prior to the first prenatal care visit with biochemical verification;
- < 25 weeks gestation;
- English speaking;
- plan on remaining in the geographical area through 12months postpartum.
- report being nonsmokers at the time they learned of the current pregnancy;
Show all 9Show fewer
- report no smoking in the past 6 month;
- Biochemical verification of non-smoker status;
- report smoking < 100 cigarettes in their lifetime;
Who cannot join
- > 25 weeks gestation;
- unavailable for routine assessments through 1 year postpartum;
- opioid substitution therapy;
- untreated/unstable serious mental illness
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Vermont, University Health Center Campus
Burlington, Vermont, 05401
About this study
Official title: Financial Incentives for Smoking Cessation Among Disadvantaged Pregnant
Investigators will examine whether adding financial incentives to current best practices for smoking cessation during pregnancy (i.e., referral to pregnancy-specific counseling using a telephone quit line) increases cessation rates and improves infant health. While more expensive upfront compared to best practices alone, the investigators hypothesize that this treatment approach will be economically justified by the later cost savings associated with more women quitting, having healthier babies, and needing less healthcare. It should also help to reduce the greater risk for health problems often seen among those who less well off economically.
Read the detailed description
Smoking during pregnancy is the leading preventable cause of poor pregnancy outcomes in the U.S. Most pregnant smokers continue smoking through pregnancy producing serious immediate and longer-term adverse health consequences for the infant. Smoking during pregnancy is highly associated with economic disadvantage and a substantive contributor to health disparities.
Efficacious interventions are available, but cessation rates are low (<20%) and improvements in birth outcomes often modest or absent. Current treatments usually entail relatively brief, lower-cost interventions (e.g., pregnancy specific quit lines). There is broad consensus that more effective interventions are sorely needed. This team of investigators has developed a novel behavioral economic intervention in which women earn financial incentives contingent on smoking abstinence. In a metaanalysis of treatments for smoking during pregnancy, effect sizes achieved with financial incentives were several fold larger than those achieved with lower intensity approaches or medications. The intervention also appears to improve birth outcomes and increase breastfeeding duration. While highly promising, further research is needed in at least three areas. (1) The evidence on birth outcomes and breastfeeding is from studies that combined data across trials rather than a single prospective trial, (2) whether the intervention produces other postpartum improvements in health has not been investigated, and (3) the overall cost-effectiveness of this approach has not been examined.
To examine these unanswered questions, the investigators are proposing a randomized, controlled clinical trial comparing the efficacy and cost effectiveness through one year postpartum of current best practices for smoking cessation during pregnancy vs. best practices plus financial incentives among 230 pregnant, Medicaid recipients. A third condition of 115 pregnant nonsmokers matched to the smokers on sociodemographic and health conditions will be included as well to compare the extent to which the treatments reduce the burden of smoking and to estimate how much more might be accomplished by further improvements in this incentives intervention without exceeding cost-effectiveness.
The investigators hypothesize that best practices plus financial incentives will be more effective than usual care practices alone, that the incentives intervention will be cost effective, and that while adding the incentives reduces a greater proportion of the health and economic burden of smoking than best practices alone, more can be done while remaining cost effective.
Overall, the proposed study has the potential to substantially advance knowledge on cost-effective smoking cessation for pregnant women. Importantly, because of the strong association between smoking during pregnancy and economic disadvantage, the proposed study also has the potential to contribute new knowledge relevant to reducing the serious challenges of health disparities.
- Conditions
- Cigarette Smoking
- Being tested
- Best practices, financial incentives
- Keywords
- smoking, pregnancy, cessation, incentives
- Medical subject headings
- Cigarette Smoking, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best practicesBehavioural
Also called Five As plus referral to pregnancy-specific quit line
financial incentivesBehavioural
Also called contingency management
financial incentives provided contingent on biochemically confirmed smoking abstinence
| Study group | Role | What they receive |
|---|---|---|
| Best practices for pregnant smokers | Experimental | Five As plus referral to pregnancy-specific tobacco quit line Receives: Behavioral: Best practices |
| Best practices plus financial incentives | Experimental | Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum. Receives: Behavioral: Best practices; Behavioral: financial incentives |
| Never-smoker comparison condition | No intervention | We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day Point Prevalence Abstinence Levels at Final Antepartum Assessment
Abstinence was defined as woman reports that she has not smoked, not even a puff, in the past 7 days and self-report is biochemically verified via urine cotinine testing
Measured: collected once per women at approximately 28-weeks gestation in each of the two smoking arms
Secondary outcomes (14)
7-day Point Prevalence Abstinence Postpartum
Compare two treatment arms on 7-day point-prevalence abstinence assessed at 2-, 4-, 8-, 12-, 24- and 48-weeks postpartum. Abstinence was defined as self-report of no smoking in past 7 days, not even a puff, with biochemical verification of self-report using urine cotinine testing
Measured: Repeated assessments completed at 2-, 4-, 8-, 12-, 24-, and 48-weeks postpartum
Breastfeeding in the Three Trial Arms
Compare the three trial arms on overall percentage of women continuing to breastfeed at repeated postpartum assessments
Measured: Repeated assessments completed at 2-, 4-, 8-, 12-, 24-, and 48-weeks postpartum
Breastfeeding While Abstinent From Smoking
We compared the three trial arms on the percent of women who reported breastfeeding and were biochemically confirmed to be abstinent from smoking at each postpartum assessment.
Measured: Repeated assessments completed at 2-, 4-, 8-, 12-, 24-, and 48-weeks postpartum
Craving Item From the Minnesota Nicotine Withdrawal Scale (MNWS).
The craving item is on a 0 (none) to 4 (severe) scale. We report mean (SEM) scores.
Measured: Outcomes reported for 8 assessments (early pregnancy, late pregnancy, 2, 4, 8, 12, 24, 28 weeks postpartum.
Nicotine Withdrawal Total Scores for the Two Smoking-cessation Trial Conditions.
Reporting mean total scores and SEM from the Minnesota Nicotine Withdrawal Scale (MNWS). Total score is an average of 7 items, with each item on a 0 (none) to 4 (severe) scale.
Measured: Outcomes reported for 8 assessments (early pregnancy, late pregnancy, 2, 4, 8, 12, 24, 28 weeks postpartum.
Infant Growth in First Year of Life
Infant growth (length \& weight) expressed a Body Mass Index (BMI) percentile score was assessed at delivery, 24- and 48-week postpartum assessments.
Measured: delivery, 24-week, and 50-week postpartum assessments
Birth Outcomes (% Small for Gestational Age Deliveries)
Birth outcomes were compared between the three study arms. Small for gestational age was defined as <10th percentile using INTERGROWTH-21st [2021] https://intergrowth21.tghn.org/about/about-us/.
Measured: delivery
Birth Outcomes (Percent Preterm [<37 Weeks] Deliveries)
Compared the three trials conditions on preterm deliveries.
Measured: at delivery
Birth Outcomes (NICU Admissions)
Compared three trial conditions on percent of NICU admissions
Measured: at delivery
Ages & Stages Questionnaire (ASQ)
The ASQ assesses infant development in five areas (communication [Comm], gross motor [GM], fine motor [FM], problem solving [PrbSlv], personal-social [PerSoc]); Each area includes six items, each with a possible value of 0, 5, 10, along with a cutoff to dichotomize infants into typical/normal vs. monitor/potential delay categories for an area. Scores in each area are compared to norms; scores with 1 standard deviation of the norm mean are categorized as typical/normal and those greater than one standard deviation below the norm mean are categorized as monitor/potential delay. We report the dichotomized outcomes for each of the six areas at the 24-week and 48-week assessments noting the number of infants in each treatment condition in the monitor/potential delay category.
Measured: 24- and 48-weeks postpartum
Birth Outcome: Gestational Age at Delivery
Birth outcomes were obtained from the birth record. Gestational age was expressed in weeks.
Measured: at delivery
Cost Per Participant
Cost per participant for BP+FI and BP interventions. These costs per participant are used in calculation of the Incremental Cost Effectiveness Ratio (ICER). This ICER measure is the added healthcare sector cost per participant for BP+FI compared to BP relative to estimated net health gain per participant (QALY). Maternal net health gains in QALYs from cessation difference between treatment conditions at 24 weeks postpartum were based on Stapleton \& West, 2012, Nicotine Tob Res; 14: 463-71.
Measured: Trial entry through 24-weeks postpartum (approximately one year following smoking-cessation quit date).
Quality of Life Years Gained (QALYs)
Smoking abstinence at the 24-week assessment was converted into quality of life years gained using standardized tables reported in Stapleton \& West, 2012, Nicotine Tob Res; 14: 463-71.
Measured: 24 weeks postpartum
Incremental Cost Effectiveness Ratio (ICER)
A summary measure representing the economic value of an intervention (BP+FI) compared with an alternative (BP). The measure type used below is 'number' due to the fact that this measure is simply a ratio of mean dollars divided by mean years gained between the treatment conditions. Thus there was no alternative measure type that could be used or measure of dispersion available.
Measured: 24 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study start31 Jan 2014
- Primary completion31 Jan 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cigarette SmokingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Stephen T. Higgins, PhD, University of Vermont
- Investigators
- Stephen T Higgins, PhD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210832
- Sponsor's protocol ID
- 1R01HD075669-01
- Other IDs
- R01HD075669-01
- Status last verified
- May 2023
- First submitted
- 31 Jul 2014
- Last updated
- 24 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Higgins ST, Washio Y, Heil SH, Solomon LJ, Gaalema DE, Higgins TM, Bernstein IM. Financial incentives for smoking cessation among pregnant and newly postpartum women. Prev Med. 2012 Nov;55 Suppl(Suppl):S33-40. doi: 10.1016/j.ypmed.2011.12.016. Epub 2011 Dec 27.
PubMed 22227223Shepard DS, Slade EP, Nighbor TD, DeSarno MJ, Roemhildt ML, Williams RK, Higgins ST. Economic analysis of financial incentives for smoking cessation during pregnancy and postpartum. Prev Med. 2022 Dec;165(Pt B):107079. doi: 10.1016/j.ypmed.2022.107079. Epub 2022 May 6.
PubMed 35533885Higgins ST, Nighbor TD, Kurti AN, Heil SH, Slade EP, Shepard DS, Solomon LJ, Lynch ME, Johnson HK, Markesich C, Rippberger PL, Skelly JM, DeSarno M, Bunn J, Hammond JB, Roemhildt ML, Williams RK, O'Reilly DM, Bernstein IM. Randomized Controlled Trial Examining the Efficacy of Adding Financial Incentives to Best practices for Smoking Cessation Among pregnant and Newly postpartum Women. Prev Med. 2022 Dec;165(Pt B):107012. doi: 10.1016/j.ypmed.2022.107012. Epub 2022 Mar 3.
PubMed 35248683
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Financial Incentives for Smoking Cessation Among Disadvantaged Pregnant
- ClinicalTrials.gov ID
- NCT02210832
- Acronym / sponsor ID
- 1R01HD075669-01
- Conditions
- Cigarette Smoking
- Keywords
- smoking, pregnancy, cessation, incentives
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Centers for Disease Control and Prevention
- Study start
- 31 Jan 2014
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 7 Aug 2014 (estimated)
- Results
- Posted 24 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators will examine whether adding financial incentives to current best practices for smoking cessation during pregnancy (i.e., referral to pregnancy-specific counseling using a telephone quit line) increases cessation rates and improves infant health. While more expensive upfront compared to best practices alone, the investigators hypothesize that this treatment approach will be economically justified by the later cost savings associated with more women quitting, having healthier babies, and needing less healthcare. It should also help to reduce the greater risk for health problems often seen among those who less well off economically.
Detailed description
Smoking during pregnancy is the leading preventable cause of poor pregnancy outcomes in the U.S. Most pregnant smokers continue smoking through pregnancy producing serious immediate and longer-term adverse health consequences for the infant. Smoking during pregnancy is highly associated with economic disadvantage and a substantive contributor to health disparities.
Efficacious interventions are available, but cessation rates are low (<20%) and improvements in birth outcomes often modest or absent. Current treatments usually entail relatively brief, lower-cost interventions (e.g., pregnancy specific quit lines). There is broad consensus that more effective interventions are sorely needed. This team of investigators has developed a novel behavioral economic intervention in which women earn financial incentives contingent on smoking abstinence. In a metaanalysis of treatments for smoking during pregnancy, effect sizes achieved with financial incentives were several fold larger than those achieved with lower intensity approaches or medications. The intervention also appears to improve birth outcomes and increase breastfeeding duration. While highly promising, further research is needed in at least three areas. (1) The evidence on birth outcomes and breastfeeding is from studies that combined data across trials rather than a single prospective trial, (2) whether the intervention produces other postpartum improvements in health has not been investigated, and (3) the overall cost-effectiveness of this approach has not been examined.
To examine these unanswered questions, the investigators are proposing a randomized, controlled clinical trial comparing the efficacy and cost effectiveness through one year postpartum of current best practices for smoking cessation during pregnancy vs. best practices plus financial incentives among 230 pregnant, Medicaid recipients. A third condition of 115 pregnant nonsmokers matched to the smokers on sociodemographic and health conditions will be included as well to compare the extent to which the treatments reduce the burden of smoking and to estimate how much more might be accomplished by further improvements in this incentives intervention without exceeding cost-effectiveness.
The investigators hypothesize that best practices plus financial incentives will be more effective than usual care practices alone, that the incentives intervention will be cost effective, and that while adding the incentives reduces a greater proportion of the health and economic burden of smoking than best practices alone, more can be done while remaining cost effective.
Overall, the proposed study has the potential to substantially advance knowledge on cost-effective smoking cessation for pregnant women. Importantly, because of the strong association between smoking during pregnancy and economic disadvantage, the proposed study also has the potential to contribute new knowledge relevant to reducing the serious challenges of health disparities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Best practices for pregnant smokers | Experimental | Behavioral: Best practicesFive As plus referral to pregnancy-specific tobacco quit line |
| Best practices plus financial incentives | Experimental | Behavioral: Best practices, Behavioral: financial incentivesBest practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum. |
| Never-smoker comparison condition | No intervention | –We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- report being smokers at the time that they learned of the current pregnancy;
- report smoking in the 7 days prior to the first prenatal care visit with biochemical verification;
- < 25 weeks gestation;
- English speaking;
- plan on remaining in the geographical area through 12months postpartum.
Key exclusion criteria (4 listed)
- > 25 weeks gestation;
- unavailable for routine assessments through 1 year postpartum;
- opioid substitution therapy;
- untreated/unstable serious mental illness
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 |
|---|---|---|
| Best practicesAlso: Five As plus referral to pregnancy-specific quit line | Behavioural | Best practices for pregnant smokers, Best practices plus financial incentives |
| financial incentivesAlso: contingency managementfinancial incentives provided contingent on biochemically confirmed smoking abstinence | Behavioural | Best practices plus financial incentives |
Primary outcome
7-day Point Prevalence Abstinence Levels at Final Antepartum Assessment
Time frame: collected once per women at approximately 28-weeks gestation in each of the two smoking arms
Abstinence was defined as woman reports that she has not smoked, not even a puff, in the past 7 days and self-report is biochemically verified via urine cotinine testing
14 secondary outcomes
7-day Point Prevalence Abstinence Postpartum
Time frame: Repeated assessments completed at 2-, 4-, 8-, 12-, 24-, and 48-weeks postpartum
Breastfeeding in the Three Trial Arms
Time frame: Repeated assessments completed at 2-, 4-, 8-, 12-, 24-, and 48-weeks postpartum
Breastfeeding While Abstinent From Smoking
Time frame: Repeated assessments completed at 2-, 4-, 8-, 12-, 24-, and 48-weeks postpartum
Craving Item From the Minnesota Nicotine Withdrawal Scale (MNWS).
Time frame: Outcomes reported for 8 assessments (early pregnancy, late pregnancy, 2, 4, 8, 12, 24, 28 weeks postpartum.
Nicotine Withdrawal Total Scores for the Two Smoking-cessation Trial Conditions.
Time frame: Outcomes reported for 8 assessments (early pregnancy, late pregnancy, 2, 4, 8, 12, 24, 28 weeks postpartum.
Infant Growth in First Year of Life
Time frame: delivery, 24-week, and 50-week postpartum assessments
Birth Outcomes (% Small for Gestational Age Deliveries)
Time frame: delivery
Birth Outcomes (Percent Preterm [<37 Weeks] Deliveries)
Time frame: at delivery
Birth Outcomes (NICU Admissions)
Time frame: at delivery
Ages & Stages Questionnaire (ASQ)
Time frame: 24- and 48-weeks postpartum
Birth Outcome: Gestational Age at Delivery
Time frame: at delivery
Cost Per Participant
Time frame: Trial entry through 24-weeks postpartum (approximately one year following smoking-cessation quit date).
Quality of Life Years Gained (QALYs)
Time frame: 24 weeks postpartum
Incremental Cost Effectiveness Ratio (ICER)
Time frame: 24 weeks postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22227223Higgins ST, Washio Y, Heil SH, Solomon LJ, Gaalema DE, Higgins TM, Bernstein IM. Financial incentives for smoking cessation among pregnant and newly postpartum women. Prev Med. 2012 Nov;55 Suppl(Suppl):S33-40. doi: 10.1016/j.ypmed.2011.12.016. Epub 2011 Dec 27.
- Derived from this study: PubMed 35533885Shepard DS, Slade EP, Nighbor TD, DeSarno MJ, Roemhildt ML, Williams RK, Higgins ST. Economic analysis of financial incentives for smoking cessation during pregnancy and postpartum. Prev Med. 2022 Dec;165(Pt B):107079. doi: 10.1016/j.ypmed.2022.107079. Epub 2022 May 6.
- Derived from this study: PubMed 35248683Higgins ST, Nighbor TD, Kurti AN, Heil SH, Slade EP, Shepard DS, Solomon LJ, Lynch ME, Johnson HK, Markesich C, Rippberger PL, Skelly JM, DeSarno M, Bunn J, Hammond JB, Roemhildt ML, Williams RK, O'Reilly DM, Bernstein IM. Randomized Controlled Trial Examining the Efficacy of Adding Financial Incentives to Best practices for Smoking Cessation Among pregnant and Newly postpartum Women. Prev Med. 2022 Dec;165(Pt B):107012. doi: 10.1016/j.ypmed.2022.107012. Epub 2022 Mar 3.
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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.
Stephen T Higgins, PhD principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best practices and financial incentives in people with Cigarette Smoking, run by University of Vermont 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 4 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 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day Point Prevalence Abstinence Levels at Final Antepartum Assessment (time frame: collected once per women at approximately 28-weeks gestation in each of the two smoking arms). 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 NCT02210832, which also lists 3 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 24 Aug 2023.