Substance AbuseNCT03051997
Increasing Caregiver Engagement in Juvenile Drug Courts
A study testing Caregiver Contingency Management + Usual Drug Court Treatment and Usual Drug Court Treatment in people with Substance Abuse, run by Medical University of South Carolina at 2 sites in United States.
Trial summary
The purpose of this study is to test a prize-based contingency management intervention for increasing caregiver engagement in juvenile drug court and adolescent drug treatment, and for achieving the ultimate outcomes of reduced substance use and delinquent behavior among drug court-involved youth. Read more about this study
- Who is it for?
- Ages 13 to 89 years
- Conditions the study is for
- Substance Abuse
- What is being tested?
- Caregiver Contingency Management + Usual Drug Court Treatment and Usual Drug Court Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Oct 2017to 12 Dec 2024
- 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 13 to 89 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Involved in juvenile drug court
- Aged 13-17 years
- Youth is willing to participate
- At least one caregiver is willing to participate in the youth's treatment
- Fluent in English or Spanish
- Caregiver of youth involved in juvenile drug court
Show all 10Show fewer
- Caregiver is willing to participate
- Fluent in English or Spanish
- Providing substance abuse treatment to a youth in juvenile drug court
- Personnel working in juvenile drug court
Who cannot join
- Diagnosed with intellectual disability or autism spectrum disorder
- Diagnosed with intellectual disability or autism spectrum disorder
- None
- None
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Nueces County Juvenile Court/Juvenile Treatment Court
Corpus Christi, Texas, 78415
Montgomer County Juvenile Court, 380 West Second Street
Dayton, Ohio, 45422
About this study
Official title: Behavioral Incentives to Increase Caregiver Engagement in Juvenile Drug Courts
The purpose of this study is to test a prize-based contingency management intervention for increasing caregiver engagement in juvenile drug court and adolescent drug treatment, and for achieving the ultimate outcomes of reduced substance use and delinquent behavior among drug court-involved youth.
Read the detailed description
Juvenile offenders with substance abuse problems represent a large and underserved population that is at high risk of deleterious outcomes and long-term costs for themselves, their families, communities, and society. Moreover, a high percentage of substance abusing adolescents continue to abuse substances and engage in criminal activity into adulthood. Although one juvenile justice intervention, Juvenile Drug Court (JDC), has emerged as a promising model for reducing drug use and delinquency among youth, its effectiveness is variable. Drug court outcomes may be compromised by the lack of caregiver engagement in JDC processes and adolescent drug treatment. Incorporating easily implemented evidence-based incentive programs in JDCs might improve their effectiveness in reducing youth drug use and re-offending. An extensive body of research supports the critical role that families play in the etiology, maintenance, and treatment of adolescent substance abuse. Although family-based interventions for adolescent substance abuse have been shown to be superior to other treatment modalities, parents must attend treatment and participate in meaningful ways for these superior outcomes to be realized. This randomized clinical trial will examine the efficacy of a prize-based contingency management intervention for increasing caregiver engagement (attendance and participation) in JDC and adolescent drug treatment. This caregiver contingency management intervention (CCM) will be compared with drug court treatment as usual (TAU). Increased caregiver participation is predicted to improve adolescent outcomes (decreased drug use and delinquent behavior). One hundred and eighty youth enrolled in JDC will be randomly assigned along with a parent/caregiver to TAU or CCM. Analyses will examine measures of caregiver engagement in JDC as well as youth substance use (urine drug screens) and delinquent activity. Results from this study will demonstrate the effectiveness of CCM procedures for increasing caregiver attendance and participation in JDC and adolescent drug treatment above and beyond drug court and usual care. If effective, the CCM approach may ultimately be used to enhance JDC outcomes, thereby reducing substance use and recidivism in juvenile offenders served by this promising juvenile justice intervention.
- Conditions
- Substance Abuse
- Being tested
- Caregiver Contingency Management + Usual Drug Court Treatment, Usual Drug Court Treatment
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregiver Contingency Management + Usual Drug Court TreatmentBehavioural
In addition to receiving JDC treatment as usual described below, caregiver participants will receive prize draws for engaging in activities consistent with their adolescents' successful completion of the JDC program during the time the youth is actively involved in JDC and substance abuse treatment. Specific activities that may be reinforced include: attendance at drug court hearings; accompanying the youth to probation meetings; participating in home visits; attendance at the youth's drug treatment sessions; attendance at mental health provider meetings; attending groups for parents of youth with substance abuse issues; and completing other verifiable treatment-related activities. All activities will meet the goals of (directly or indirectly) enhancing caregiver participation in the JDC and/or treatment process. Caregivers will receive escalating chances for tangible reinforcers each week for completing up to 3 of the activities agreed upon by the caregiver and the therapist.
Usual Drug Court TreatmentBehavioural
Standard outpatient substance abuse treatment services that a young person would receive while participating in JDC.
| Study group | Role | What they receive |
|---|---|---|
| Caregiver Contingency Management + Usual Drug Court Treatment | Experimental | This group will receive a caregiver contingency management intervention plus the standard outpatient substance abuse treatment services provided at JDC. Receives: Behavioral: Caregiver Contingency Management + Usual Drug Court Treatment |
| Usual Drug Court Treatment | Active comparator | This group will receive the standard outpatient substance abuse treatment services provided at JDC. Receives: Behavioral: Usual Drug Court Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Positive Urine Drug Screens at 5 Months Post-baseline
This measure reflects the number of positive urine drug screens for THC, amphetamines, methamphetamines, opiates, cocaine, benzodiazepines, MDMA, and oxycodone collected from youth participants. Assessed at baseline and 5 months; data reported for 5-month time point
Measured: Baseline to 5 months
Frequency of Substance Use and Substance-related Problems Self-reported by Youth on the Global Appraisal of Individual Needs.
The GAIN Substance Frequency Scale assesses frequency of substance use over the past 90 days. Scores range from 0 (no use) to 90 (daily use). Higher scores indicate greater substance use severity.
Measured: Baseline, 5 months
Secondary outcomes (15)
Changes From Baseline to 18 Months Post-baseline in Youth Arrests, Charges, and Convictions.
Number of youth arrests, charges, and convictions measured via official arrest records.
Measured: Baseline to 18 months
Changes From Baseline to 18 Months Post-baseline in Youth Delinquent Behaviors (Measured at 0, 3, 5, 6, 9, 12, and 18 Months).
Frequency of delinquent behaviors self-reported by youth using the Self-Report Delinquency Scale.
Measured: Baseline to 18 months
Changes From Baseline to 18 Months Post-baseline in Caregiver Reports on Youth Internalizing Symptoms and Externalizing Behaviors (Measured at 0, 1, 2, 3, 4, 5, 6, 9, 12, and 18 Months).
Frequency of youth's internalizing symptoms and externalizing behaviors measured with the Child Behavior Checklist (caregiver report).
Measured: Baseline to 18 months
Changes From Baseline to 18 Months Post-baseline in Youth Reports on Youth Internalizing Symptoms and Externalizing Behaviors (Measured at 0, 1, 2, 3, 4, 5, 6, 9, 12, and 18 Months).
Frequency of youth's internalizing symptoms and externalizing behaviors measured with the Brief Problem Checklist (youth report).
Measured: Baseline to 18 months
Changes From Baseline to Post-treatment in Caregiver Substance Use Problems.
Frequency and severity of substance use problems self-reported by caregivers on the Addiction Severity Index.
Measured: Baseline through treatment completion, an average of 4 months
Changes From Baseline to Post-treatment in Caregiver Depressive Symptoms.
Frequency and severity of depressive symptoms self-reported by caregivers on the Beck Depression Inventory.
Measured: Baseline through treatment completion, an average of 4 months
Changes From Baseline to Post-treatment in Therapist-Family Working Alliance (Measured at 1, 2, 3, and 4 Months, as Well as Post-treatment).
Levels of alliance during treatment reported by therapists, caregivers, and youth on the Working Alliance Inventory.
Measured: Baseline through treatment completion, an average of 4 months
Changes From Baseline to Post-treatment in Caregiver Treatment Attendance and Activity Completion (Measured at 1, 2, 3, and 4 Months, as Well as Post-treatment).
Frequency of caregiver attendance at their youth's substance use treatment sessions and completion of therapeutic activities reported by therapists on the Session Tracking Sheet.
Measured: Baseline through treatment completion, an average of 4 months
Changes From Baseline to the End of JDC Involvement in Caregiver Attendance at JDC Sessions.
Frequency of caregiver attendance at their youth's JDC sessions reported by JDC personnel on the JDC Attendance Form.
Measured: Baseline through the end of JDC involvement, an average of 12 months
Rates of Treatment Completion.
Rates of youth treatment completion reported by therapists using the Treatment Termination Form.
Measured: Up to 4 months on average
Levels of Satisfaction With Treatment and JDC.
Levels of satisfaction with substance use treatment and JDC reported by caregivers and youth on the Client Satisfaction Questionnaire.
Measured: Up to 4 months on average
Changes From Baseline to Post-treatment in Caregiver Perceptions of Incentive Programs.
Ratings by caregivers on perceptions of incentive-based interventions as measured by the Provider Survey of Incentives.
Measured: Baseline through treatment completion, an average of 4 months
Changes From Baseline to 36 Months Post-baseline in Therapist and JDC Personnel Perceptions of Incentive Programs (Measured at 0, 12, 24, and 36 Months).
Ratings by therapists and JDC personnel on perceptions of incentive-based interventions as measured by the Provider Survey of Incentives.
Measured: Baseline to 36 months
Reports at Post-treatment on Youth and Caregiver Attitudes Toward Incentive Programs.
Youth and caregiver attitudes toward incentive programs as measured during qualitative interviews.
Measured: Up to 4 months on average
Changes From Baseline to 36 Months Post-baseline in Therapist and JDC Personnel Attitudes Toward Incentive Programs (Measured at 0, 12, 24, and 36 Months).
Therapist and JDC personnel attitudes toward incentive programs as measured during qualitative interviews.
Measured: Baseline to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start13 Oct 2017
- Primary completion12 Dec 2023
- Study completion12 Dec 2024
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 (1)Papers the sponsor has linked to this study.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Wayne State University, Alliant International University, Baylor University
- Responsible party
- Sponsor
- Investigators
- Phillippe Cunningham, Ph.D., Principal investigator, Medical University of South CarolinaDavid Ledgerwood, Ph.D., Principal investigator, Wayne State UniversityStacy Ryan, Ph.D., Study director, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03051997
- Sponsor's protocol ID
- R01MD011322
- Other IDs
- R01MD011322
- Status last verified
- Jul 2026
- First submitted
- 8 Feb 2017
- Last updated
- 7 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ledgerwood DM, Cunningham PB. Juvenile Drug Treatment Court. Pediatr Clin North Am. 2019 Dec;66(6):1193-1202. doi: 10.1016/j.pcl.2019.08.011.
PubMed 31679607
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Incentives to Increase Caregiver Engagement in Juvenile Drug Courts
- ClinicalTrials.gov ID
- NCT03051997
- Acronym / sponsor ID
- R01MD011322
- Conditions
- Substance Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Wayne State University, Alliant International University, Baylor University
- Study start
- 13 Oct 2017 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 12 Dec 2024 (actual)
- First posted
- 14 Feb 2017 (actual)
- Results
- Posted 8 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test a prize-based contingency management intervention for increasing caregiver engagement in juvenile drug court and adolescent drug treatment, and for achieving the ultimate outcomes of reduced substance use and delinquent behavior among drug court-involved youth.
Detailed description
Juvenile offenders with substance abuse problems represent a large and underserved population that is at high risk of deleterious outcomes and long-term costs for themselves, their families, communities, and society. Moreover, a high percentage of substance abusing adolescents continue to abuse substances and engage in criminal activity into adulthood. Although one juvenile justice intervention, Juvenile Drug Court (JDC), has emerged as a promising model for reducing drug use and delinquency among youth, its effectiveness is variable. Drug court outcomes may be compromised by the lack of caregiver engagement in JDC processes and adolescent drug treatment. Incorporating easily implemented evidence-based incentive programs in JDCs might improve their effectiveness in reducing youth drug use and re-offending. An extensive body of research supports the critical role that families play in the etiology, maintenance, and treatment of adolescent substance abuse. Although family-based interventions for adolescent substance abuse have been shown to be superior to other treatment modalities, parents must attend treatment and participate in meaningful ways for these superior outcomes to be realized. This randomized clinical trial will examine the efficacy of a prize-based contingency management intervention for increasing caregiver engagement (attendance and participation) in JDC and adolescent drug treatment. This caregiver contingency management intervention (CCM) will be compared with drug court treatment as usual (TAU). Increased caregiver participation is predicted to improve adolescent outcomes (decreased drug use and delinquent behavior). One hundred and eighty youth enrolled in JDC will be randomly assigned along with a parent/caregiver to TAU or CCM. Analyses will examine measures of caregiver engagement in JDC as well as youth substance use (urine drug screens) and delinquent activity. Results from this study will demonstrate the effectiveness of CCM procedures for increasing caregiver attendance and participation in JDC and adolescent drug treatment above and beyond drug court and usual care. If effective, the CCM approach may ultimately be used to enhance JDC outcomes, thereby reducing substance use and recidivism in juvenile offenders served by this promising juvenile justice intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caregiver Contingency Management + Usual Drug Court Treatment | Experimental | Behavioral: Caregiver Contingency Management + Usual Drug Court TreatmentThis group will receive a caregiver contingency management intervention plus the standard outpatient substance abuse treatment services provided at JDC. |
| Usual Drug Court Treatment | Active comparator | Behavioral: Usual Drug Court TreatmentThis group will receive the standard outpatient substance abuse treatment services provided at JDC. |
Who may qualify
- Ages
- 13 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Involved in juvenile drug court
- Aged 13-17 years
- Youth is willing to participate
- At least one caregiver is willing to participate in the youth's treatment
- Fluent in English or Spanish
Key exclusion criteria (4 listed)
- Diagnosed with intellectual disability or autism spectrum disorder
- Diagnosed with intellectual disability or autism spectrum disorder
- None
- None
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 |
|---|---|---|
| Caregiver Contingency Management + Usual Drug Court TreatmentIn addition to receiving JDC treatment as usual described below, caregiver participants will receive prize draws for engaging in activities consistent with their adolescents' successful completion of the JDC program during the time the youth is actively involved in JDC and substance abuse treatment. Specific activities that may be reinforced include: attendance at drug court hearings; accompanying the youth to probation meetings; participating in home visits; attendance at the youth's drug treatment sessions; attendance at mental health provider meetings; attending groups for parents of youth with substance abuse issues; and completing other verifiable treatment-related activities. All activities will meet the goals of (directly or indirectly) enhancing caregiver participation in the JDC and/or treatment process. Caregivers will receive escalating chances for tangible reinforcers each week for completing up to 3 of the activities agreed upon by the caregiver and the therapist. | Behavioural | Caregiver Contingency Management + Usual Drug Court Treatment |
| Usual Drug Court TreatmentStandard outpatient substance abuse treatment services that a young person would receive while participating in JDC. | Behavioural | Usual Drug Court Treatment |
Primary outcome
Number of Participants With Positive Urine Drug Screens at 5 Months Post-baseline
Time frame: Baseline to 5 months
This measure reflects the number of positive urine drug screens for THC, amphetamines, methamphetamines, opiates, cocaine, benzodiazepines, MDMA, and oxycodone collected from youth participants. Assessed at baseline and 5 months; data reported for 5-month time point
Frequency of Substance Use and Substance-related Problems Self-reported by Youth on the Global Appraisal of Individual Needs.
Time frame: Baseline, 5 months
The GAIN Substance Frequency Scale assesses frequency of substance use over the past 90 days. Scores range from 0 (no use) to 90 (daily use). Higher scores indicate greater substance use severity.
15 secondary outcomes
Changes From Baseline to 18 Months Post-baseline in Youth Arrests, Charges, and Convictions.
Time frame: Baseline to 18 months
Changes From Baseline to 18 Months Post-baseline in Youth Delinquent Behaviors (Measured at 0, 3, 5, 6, 9, 12, and 18 Months).
Time frame: Baseline to 18 months
Changes From Baseline to 18 Months Post-baseline in Caregiver Reports on Youth Internalizing Symptoms and Externalizing Behaviors (Measured at 0, 1, 2, 3, 4, 5, 6, 9, 12, and 18 Months).
Time frame: Baseline to 18 months
Changes From Baseline to 18 Months Post-baseline in Youth Reports on Youth Internalizing Symptoms and Externalizing Behaviors (Measured at 0, 1, 2, 3, 4, 5, 6, 9, 12, and 18 Months).
Time frame: Baseline to 18 months
Changes From Baseline to Post-treatment in Caregiver Substance Use Problems.
Time frame: Baseline through treatment completion, an average of 4 months
Changes From Baseline to Post-treatment in Caregiver Depressive Symptoms.
Time frame: Baseline through treatment completion, an average of 4 months
Changes From Baseline to Post-treatment in Therapist-Family Working Alliance (Measured at 1, 2, 3, and 4 Months, as Well as Post-treatment).
Time frame: Baseline through treatment completion, an average of 4 months
Changes From Baseline to Post-treatment in Caregiver Treatment Attendance and Activity Completion (Measured at 1, 2, 3, and 4 Months, as Well as Post-treatment).
Time frame: Baseline through treatment completion, an average of 4 months
Changes From Baseline to the End of JDC Involvement in Caregiver Attendance at JDC Sessions.
Time frame: Baseline through the end of JDC involvement, an average of 12 months
Rates of Treatment Completion.
Time frame: Up to 4 months on average
Levels of Satisfaction With Treatment and JDC.
Time frame: Up to 4 months on average
Changes From Baseline to Post-treatment in Caregiver Perceptions of Incentive Programs.
Time frame: Baseline through treatment completion, an average of 4 months
Changes From Baseline to 36 Months Post-baseline in Therapist and JDC Personnel Perceptions of Incentive Programs (Measured at 0, 12, 24, and 36 Months).
Time frame: Baseline to 36 months
Reports at Post-treatment on Youth and Caregiver Attitudes Toward Incentive Programs.
Time frame: Up to 4 months on average
Changes From Baseline to 36 Months Post-baseline in Therapist and JDC Personnel Attitudes Toward Incentive Programs (Measured at 0, 12, 24, and 36 Months).
Time frame: Baseline to 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31679607Ledgerwood DM, Cunningham PB. Juvenile Drug Treatment Court. Pediatr Clin North Am. 2019 Dec;66(6):1193-1202. doi: 10.1016/j.pcl.2019.08.011.
- Individual participant dataSharing planned: No
Related trials for Substance Abuse
RecruitingPhase 3
Nabilone for Agitation Blinded Intervention Trial
Alzheimer Disease, Agitation
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
Active, not recruitingPhase 1
Psilocybin-assisted Treatment for Cannabis Use Disorder
Cannabis Use Disorder
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
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.
Phillippe Cunningham, Ph.D. principal investigator
Medical University of South Carolina
David Ledgerwood, Ph.D. principal investigator
Wayne State University
Stacy Ryan, Ph.D. study director
The University of Texas Health Science Center at San Antonio
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caregiver Contingency Management + Usual Drug Court Treatment and Usual Drug Court Treatment in people with Substance Abuse, run by Medical University of South Carolina at 2 sites 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 10 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 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 8 Dec 2025). 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?
Number of Participants With Positive Urine Drug Screens at 5 Months Post-baseline (time frame: Baseline to 5 months). The study lists 2 primary outcomes in all. 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 NCT03051997, 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 Aug 2026.