Mental HealthSTAR-RNCT07555145
Supporting Treatment Access and Recovery in Re-entry (STAR-R)
A study testing Full MISSION-CJ and Peer Linkage Support in people with Mental Health and Substance Use Disorders, run by University of Massachusetts, Worcester at 2 sites in United States.
Trial summary
This application is aimed at testing a multicomponent intervention called "Maintaining Independence and Sobriety through Systems Integration, Outreach, and Networking-Criminal Justice (MISSION-CJ) or Peer Linkage Support post-release from two jails in Massachusetts for individuals with co-occurring substance use and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health, Substance Use Disorders, Co-occurring Mental and Substance Use Disorders
- What is being tested?
- Full MISSION-CJ and Peer Linkage Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2026to 31 Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 18 years or older;
- Proficient in reading and writing in the English language;
- Are released from one of the participating jail/s; and
- Have a current co-occurring substance use and mental health disorder, which includes both any substance use disorder (including alcohol) and mental health disorder (including depression, anxiety, trauma related disorders, bipolar, and/or schizophrenia) as documented by the participating jails.
Who cannot join
- Are acutely suicidal based on the CSSRS; or
- Are acutely psychotic (as this would require a higher level of care) based on SCID-5-RV.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Hampshire County Jail and House of Correction
Northampton, Massachusetts, 01060
Patrick Cahillane, 413-582-7703, patrick.cahillane@hsd.state.ma.us
Worceseter County Jail and House of Correction
West Boylston, Massachusetts, 01583
Jason Butland, 508-854-1800, jbutland@sdw.state.ma.us
About this study
This application is aimed at testing a multicomponent intervention called "Maintaining Independence and Sobriety through Systems Integration, Outreach, and Networking-Criminal Justice (MISSION-CJ) or Peer Linkage Support post-release from two jails in Massachusetts for individuals with co-occurring substance use and mental health disorders (COD), given high rates of COD among incarcerated populations. The research will examine engagement in treatment, behavioral health outcomes, mediators and moderators, an economic analysis, and facilitators and barriers of MISSION-CJ implementation.
Read the detailed description
Individuals with substance use and mental health conditions (COD) are overrepresented in criminal legal (CL) settings, including jails with 50% having a COD. Compared to having a single disorder, those with a COD have more serious criminal histories, childhood traumas, reincarceration, suicide, homelessness, unemployment, poor treatment engagement, and a tenfold increased risk of overdosing within 3 months of release. While treatments exist to address mental health, substance use, CL prosocial thinking, and social determinants of health (SDOH) needs separately, there is an absence of comprehensive re-entry approaches that address these needs simultaneously, which can result in care fragmentation, poor treatment engagement, relapses, and a vicious cycle of reincarceration. Maintaining Independence and Sobriety through Systems Integration, Outreach, and Networking-Criminal Justice version (MISSION-CJ) is a promising, cross-disciplinary multicomponent intervention, offering 6 months of COD treatment, prosocial and recovery services, and assertive outreach. Four MISSION-CJ open pilots demonstrated increased treatment engagement, improved behavioral health outcomes, and reduced recidivism for clients with a COD. The investigators also have a MISSION-CJ Manual, Workbook, Treatment Planning Tool, and Fidelity Measure and are ready to test them in this RCT. In response to RFA-DA-25-062, the proposed 5-year study, "Supporting Treatment Access and Recovery in Re-entry (STAR-R)," will randomize 240 people with COD to MISSION-CJ or Peer Linkage Support (PLS). Study aims include Aim 1: Compared to PLS, those receiving MISSION-CJ are hypothesized to show: (1a) greater engagement in treatment (measured by total days participated in each condition), and total community provider linkages sessions); (1b) Reduced substance use (measured by self-report use days); reduced overdose risk (measured by self-report Overdose Risk Questionnaire) / overdoses (self-report and corroborated with surveillance data); and reduced mental health symptoms (measured by self-report mental health symptoms); (1c) less CL recidivism (measured by fewer days in jail and fewer numbers of arrests). Aim 2: Examine mechanisms impacting Aim 1 outcomes. Treatment effects will be mediated by: (i) recidivism risk; (ii) increased affiliations with prosocial peers; (iii) reduced affiliations with antisocial peers; and (iv) increased community integration; and will be moderated by demographic factors and COD severity. Aim 3: To conduct a comprehensive economic evaluation that will (i) estimate the full implementation (start-up and ongoing) costs associated with MISSION-CJ and PLS, and (ii) evaluate the cost-effectiveness of MISSION-CJ compared to PLS, from the healthcare system and societal perspectives. Aim 4. To examine facilitators and barriers of MISSION-CJ implementation via qualitative interviews with participants (n=20) and staff (N=12). This application is responsive to NIDA priorities by proposing to improve treatment within the CL system, and to optimize continuity of care post incarceration, and the JCOIN goals of addressing the intersection of the CL system and the community-based healthcare system.
- Being tested
- Full MISSION-CJ, Peer Linkage Support
- Keywords
- MISSION-CJ, co-occurring disorders, peer linkage support, mental health, substance use disorders
- Medical subject headings
- Psychological Well-Being, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full MISSION-CJBehavioural
MISSION-CJ is a time-limited, cross disciplinary, team-based wraparound approach that provides 6 months of psychosocial treatment combined with assertive outreach, empowering clients to access and engage in care and community services to promote recovery and address criminogenic risk. The MISSION-CJ treatment curriculum integrates 3 evidence-based practices: 1) Critical Time Intervention (CTI), a time-limited form of assertive community treatment; 2) Dual Recovery Therapy (DRT), which is integrated mental health and substance use group therapy; and 3) Peer Support (PS), offering support for people in recovery by people in recovery.
Peer Linkage SupportBehavioural
Linkage only is provided via Peer Specialists whom have lived experiences similar to that of our participants. Linkage only includes informal treatment planning and linkages and supports to needed community services.
| Study group | Role | What they receive |
|---|---|---|
| Full MISSION-CJ | Experimental | Participants assigned to this condition will receive full MISSION-CJ services. MISSION-CJ services include 6-months of integrated mental health and substance use treatment and treatment planning with the MISSION-CJ Case Manager (13 session curriculum) and Peer Support Specialist (11 session curriculum). Content of these sessions will be directed using the MISSION-CJ Treatment Manual and Consumer Workbooks. MISSION-CJ teams will also provide linkages and supports to treatment services within the participant's community throughout the duration of the study. Receives: Behavioral: Full MISSION-CJ |
| Peer Linkage Support | Active comparator | Our Linkage only arm delivered by a Peer Specialist will act as the comparison group to the MISSION-CJ arm. Participants randomized to the linkage only arm will receive 6-months of linkage care from a Peer Specialist. The Peer Specialist will provide informal treatment planning as well as linkages and support to community services, but will not provide integrated dual disorders treatment, nor will this arm utilize any MISSION-CJ materials or offer Peer led groups. Receives: Behavioral: Peer Linkage Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement in Treatment
Measured by total days participating in each condition using fidelity logs adapted for each treatment arm.
Measured: Measured weekly through 6-months post enrollment
Engagement in Treatment
Measured by total community provider linkages
Measured: 6-months post enrollment
Engagement in Treatment
Measured by total days participating in other healthcare services. Measured using an adapted version of the Treatment Services Review (TSR)
Measured: Measured at baseline, 3, 6, 9, 12-months post enrollment
Secondary outcomes (12)
Self-reported Substance Use
Measured as self-reported days of use using the Timeline Follow back (TLFB)
Measured: Measured at baseline, 3, 6, 9, 12-months post enrollment
Overdose Risk
Measured by self-report using the Overdose Risk Questionnaire (OdRi). The OdRi is a 25-item scale scored on a scale between 0 and 25, with greater scores indicating greater risk of overdose.
Measured: Measured at baseline, 3, 6, 9, 12-months post enrollment.
Overdoses from substances
Measured as self-reported overdoses, and corroborated with surveillance data from the Vitals and MATRIS databases within the Massachusetts Public Health Data Warehouse (MA PHDW)
Measured: Self reported overdoses measured at baseline, 3, 6, 9, 12-months post enrollment. Surveillance data will be captured in a one time data request from the MA PHDW post-enrollment.
Mental Health Symptoms
Measured by self-reported days of mental health symptoms using the Behavior and Symptom Identification Scale (BASIS-24). This is a 24-item measure scored on a scale of 0 to 4, with greater scores indicating more mental health problems and greater functional impairment.
Measured: Measured at baseline, 3, 6, 9, 12-months post enrollment
Recidivism Risk
Measured using the Level of Service Inventory-Revised scale (LSI-R). The LSI-R is scored on a scale of 0-54, with greater scores indicating greater risk of criminal and legal recidivism.
Measured: Measured at baseline, 3, 6, 9, 12-months post enrollment
Current Recidivism
Measured using data extracted from Vinelink. Vinelink provides information on current incarcerations. Thus, recidivism data captured will include if the participant is currently incarcerated or not (i.e. yes or no).
Measured: One time data extract at study conclusion to see if any participants are currently incarcerated.
Recidivism
Measured using data extracted from Massachusetts Public Health Data Warehouse (MA PHDW). Recidivism data captured from MA PHDW will include days in prison or jail during the period of enrollment.
Measured: One time data extract from MA PHDW at the conclusion of the study.
Recidivism
Measured using data extracted from Massachusetts Public Health Data Warehouse (MA PHDW). Recidivism data captured from MA PHDW will include number of arrests during the period of enrollment.
Measured: One time data extract from MA PHDW at the conclusion of the study.
Recidivism
Measured using data extracted from participating jails. Recidivism data from participating jails will include days in prison or jail during enrollment. This data will be compared with recidivism data extracted from MA PHDW.
Measured: One time data extract at the conclusion of the study.
Recidivism
Measured using data extracted from participating jails. Recidivism data from participating jails will include number of arrests during enrollment. This data will be compared with recidivism data extracted from MA PHDW.
Measured: One time data extract at the conclusion of the study.
Mental Health Symptoms: Trauma Symptoms
Measured using the Post-Traumatic Stress Disorder Checklist 5 (PCL-5). The PCL-5 is scored on a scale of 0 to 80, with greater scores indicating greater severity with post-traumatic stress symptoms.
Measured: Measured at baseline, 3, 6, 9, 12-months post enrollment
Quality Adjusted Life Years (QALYs): health
Measured by self-report on the 5-level EQ-5D (EQ-5D-5L). Scores range from 0 (worst imaginable health) to 100 (best imaginable health).
Measured: Measured at baseline, 3, 6, 9, and 12-months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 May 2030 (estimated)
- Study completion31 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe 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
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Cornell University, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, David Smelson, University of Massachusetts, Worcester
- Investigators
- David Smelson, PsyD, Principal investigator, University of Massachusetts, WorcesterPaige Shaffer, PhD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555145
- Sponsor's protocol ID
- STUDY00002781
- Other IDs
- R01DA064494
- Acronym
- STAR-R
- Status last verified
- Sep 2026
- First submitted
- 13 Apr 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Consistent with the NIH and the JCOIN Initiative, Underlying Primary Data collected from participants in this project will be made readily available to the public through regular submissions to the Methodology and Advanced Analytics Resource Center (MAARC) and Syracuse Qualitative Data Repository for both quantitative and qualitative data collected respectively. In consultation with the University of Massachusetts Chan Medical School's institutional review board (IRB), project consent forms will include relevant information for participants to be made aware that their de-identified data will be available to other investigators as a part of the JCOIN Initiative Public Access and Data Sharing Policy.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Treatment Access and Recovery in Re-entry (STAR-R)
- ClinicalTrials.gov ID
- NCT07555145
- Acronym / sponsor ID
- STAR-R / STUDY00002781
- Keywords
- MISSION-CJ, co-occurring disorders, peer linkage support, mental health, substance use disorders
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Cornell University, National Institute on Drug Abuse (NIDA)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 May 2030 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 29 Apr 2026 (actual)
- 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.
This application is aimed at testing a multicomponent intervention called "Maintaining Independence and Sobriety through Systems Integration, Outreach, and Networking-Criminal Justice (MISSION-CJ) or Peer Linkage Support post-release from two jails in Massachusetts for individuals with co-occurring substance use and mental health disorders (COD), given high rates of COD among incarcerated populations. The research will examine engagement in treatment, behavioral health outcomes, mediators and moderators, an economic analysis, and facilitators and barriers of MISSION-CJ implementation.
Detailed description
Individuals with substance use and mental health conditions (COD) are overrepresented in criminal legal (CL) settings, including jails with 50% having a COD. Compared to having a single disorder, those with a COD have more serious criminal histories, childhood traumas, reincarceration, suicide, homelessness, unemployment, poor treatment engagement, and a tenfold increased risk of overdosing within 3 months of release. While treatments exist to address mental health, substance use, CL prosocial thinking, and social determinants of health (SDOH) needs separately, there is an absence of comprehensive re-entry approaches that address these needs simultaneously, which can result in care fragmentation, poor treatment engagement, relapses, and a vicious cycle of reincarceration. Maintaining Independence and Sobriety through Systems Integration, Outreach, and Networking-Criminal Justice version (MISSION-CJ) is a promising, cross-disciplinary multicomponent intervention, offering 6 months of COD treatment, prosocial and recovery services, and assertive outreach. Four MISSION-CJ open pilots demonstrated increased treatment engagement, improved behavioral health outcomes, and reduced recidivism for clients with a COD. The investigators also have a MISSION-CJ Manual, Workbook, Treatment Planning Tool, and Fidelity Measure and are ready to test them in this RCT. In response to RFA-DA-25-062, the proposed 5-year study, "Supporting Treatment Access and Recovery in Re-entry (STAR-R)," will randomize 240 people with COD to MISSION-CJ or Peer Linkage Support (PLS). Study aims include Aim 1: Compared to PLS, those receiving MISSION-CJ are hypothesized to show: (1a) greater engagement in treatment (measured by total days participated in each condition), and total community provider linkages sessions); (1b) Reduced substance use (measured by self-report use days); reduced overdose risk (measured by self-report Overdose Risk Questionnaire) / overdoses (self-report and corroborated with surveillance data); and reduced mental health symptoms (measured by self-report mental health symptoms); (1c) less CL recidivism (measured by fewer days in jail and fewer numbers of arrests). Aim 2: Examine mechanisms impacting Aim 1 outcomes. Treatment effects will be mediated by: (i) recidivism risk; (ii) increased affiliations with prosocial peers; (iii) reduced affiliations with antisocial peers; and (iv) increased community integration; and will be moderated by demographic factors and COD severity. Aim 3: To conduct a comprehensive economic evaluation that will (i) estimate the full implementation (start-up and ongoing) costs associated with MISSION-CJ and PLS, and (ii) evaluate the cost-effectiveness of MISSION-CJ compared to PLS, from the healthcare system and societal perspectives. Aim 4. To examine facilitators and barriers of MISSION-CJ implementation via qualitative interviews with participants (n=20) and staff (N=12). This application is responsive to NIDA priorities by proposing to improve treatment within the CL system, and to optimize continuity of care post incarceration, and the JCOIN goals of addressing the intersection of the CL system and the community-based healthcare system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full MISSION-CJ | Experimental | Behavioral: Full MISSION-CJParticipants assigned to this condition will receive full MISSION-CJ services. MISSION-CJ services include 6-months of integrated mental health and substance use treatment and treatment planning with the MISSION-CJ Case Manager (13 session curriculum) and Peer Support Specialist (11 session curriculum). Content of these sessions will be directed using the MISSION-CJ Treatment Manual and Consumer Workbooks. MISSION-CJ teams will also provide linkages and supports to treatment services within the participant's community throughout the duration of the study. |
| Peer Linkage Support | Active comparator | Behavioral: Peer Linkage SupportOur Linkage only arm delivered by a Peer Specialist will act as the comparison group to the MISSION-CJ arm. Participants randomized to the linkage only arm will receive 6-months of linkage care from a Peer Specialist. The Peer Specialist will provide informal treatment planning as well as linkages and support to community services, but will not provide integrated dual disorders treatment, nor will this arm utilize any MISSION-CJ materials or offer Peer led groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older;
- Proficient in reading and writing in the English language;
- Are released from one of the participating jail/s; and
- Have a current co-occurring substance use and mental health disorder, which includes both any substance use disorder (including alcohol) and mental health disorder (including depression, anxiety, trauma related disorders, bipolar, and/or schizophrenia) as documented by the participating jails.
Key exclusion criteria (2 listed)
- Are acutely suicidal based on the CSSRS; or
- Are acutely psychotic (as this would require a higher level of care) based on SCID-5-RV.
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 |
|---|---|---|
| Full MISSION-CJMISSION-CJ is a time-limited, cross disciplinary, team-based wraparound approach that provides 6 months of psychosocial treatment combined with assertive outreach, empowering clients to access and engage in care and community services to promote recovery and address criminogenic risk. The MISSION-CJ treatment curriculum integrates 3 evidence-based practices: 1) Critical Time Intervention (CTI), a time-limited form of assertive community treatment; 2) Dual Recovery Therapy (DRT), which is integrated mental health and substance use group therapy; and 3) Peer Support (PS), offering support for people in recovery by people in recovery. | Behavioural | Full MISSION-CJ |
| Peer Linkage SupportLinkage only is provided via Peer Specialists whom have lived experiences similar to that of our participants. Linkage only includes informal treatment planning and linkages and supports to needed community services. | Behavioural | Peer Linkage Support |
Primary outcome
Engagement in Treatment
Time frame: Measured weekly through 6-months post enrollment
Measured by total days participating in each condition using fidelity logs adapted for each treatment arm.
Engagement in Treatment
Time frame: 6-months post enrollment
Measured by total community provider linkages
Engagement in Treatment
Time frame: Measured at baseline, 3, 6, 9, 12-months post enrollment
Measured by total days participating in other healthcare services. Measured using an adapted version of the Treatment Services Review (TSR)
12 secondary outcomes
Self-reported Substance Use
Time frame: Measured at baseline, 3, 6, 9, 12-months post enrollment
Overdose Risk
Time frame: Measured at baseline, 3, 6, 9, 12-months post enrollment.
Overdoses from substances
Time frame: Self reported overdoses measured at baseline, 3, 6, 9, 12-months post enrollment. Surveillance data will be captured in a one time data request from the MA PHDW post-enrollment.
Mental Health Symptoms
Time frame: Measured at baseline, 3, 6, 9, 12-months post enrollment
Recidivism Risk
Time frame: Measured at baseline, 3, 6, 9, 12-months post enrollment
Current Recidivism
Time frame: One time data extract at study conclusion to see if any participants are currently incarcerated.
Recidivism
Time frame: One time data extract from MA PHDW at the conclusion of the study.
Recidivism
Time frame: One time data extract from MA PHDW at the conclusion of the study.
Recidivism
Time frame: One time data extract at the conclusion of the study.
Recidivism
Time frame: One time data extract at the conclusion of the study.
Mental Health Symptoms: Trauma Symptoms
Time frame: Measured at baseline, 3, 6, 9, 12-months post enrollment
Quality Adjusted Life Years (QALYs): health
Time frame: Measured at baseline, 3, 6, 9, and 12-months post enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: Yes. Consistent with the NIH and the JCOIN Initiative, Underlying Primary Data collected from participants in this project will be made readily available to the public through regular submissions to the Methodology and Advanced Analytics Resource Center (MAARC) and Syracuse Qualitative Data Repository for both quantitative and qualitative data collected respectively. In consultation with the University of Massachusetts Chan Medical School's institutional review board (IRB), project consent forms will include relevant information for participants to be made aware that their de-identified data will be available to other investigators as a part of the JCOIN Initiative Public Access and Data Sharing Policy.
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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.
David Smelson, PsyD principal investigator
University of Massachusetts, Worcester
Paige Shaffer, PhD principal investigator
University of Massachusetts, Worcester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full MISSION-CJ and Peer Linkage Support in people with Mental Health and Substance Use Disorders, run by University of Massachusetts, Worcester 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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 22 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Smelson, PsyD (508-713-5420, David.Smelson@umassmed.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement in Treatment (time frame: Measured weekly through 6-months post enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.