Behavior, HealthNCT06119503
Peer-Delivered Episodic Future Thinking for Returning Citizens
A study testing Elongating Time HOrizons for Reentry (ETHoR) and Standardized Episodic Thinking (SET) in people with Behavior, Health, run by Henry Ford Health System at 1 site in United States.
Trial summary
The goal of this study is to examine the effectiveness of a brief, episodic future thinking (EFT) intervention in a substance use treatment setting serving returning citizens with substance use disorders (SUD). The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Behavior, Health
- What is being tested?
- Elongating Time HOrizons for Reentry (ETHoR) and Standardized Episodic Thinking (SET)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2023to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Experience in an incarceration setting within 12 months
- Identify as an individual in substance use recovery
- Willing to participate in the study
- Able to participate in written assessments and an intervention conducted in English
- Willing to receive brief bi-weekly check-in calls for one month, email, and other phone messages related to study participation including SMS/text messages as needed
Who cannot join
- Individuals' ineligible or unwilling to participate in study activities and assessments
- Self-reporting of active and untreated psychosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peer Delivered Episodic Future Thinking to Improve MOUD Treatment Engagement Among Returning Citizens - A Randomized Controlled Trial
The goal of this study is to examine the effectiveness of a brief, episodic future thinking (EFT) intervention in a substance use treatment setting serving returning citizens with substance use disorders (SUD).
The main questions it aims to answer are:
Read more
- Determine preliminary implementation potential of the EFT intervention, including acceptability and feasibility of conducting the intervention.
- Examine the preliminary effectiveness of this approach, with a specific focus on patient outcomes, including changes in delay discounting, treatment retention, treatment motivation, and substance use.
Participants will be asked to participant in pre and post assessment questionnaires, participate in a single-episode brief intervention followed by tailored phone call follow-ups.
Read the detailed description
Returning citizens with substance use disorders (SUD) are at the greatest risk for overdose in the first two weeks following the transition from incarceration. Thus, the reentry period is of specific importance for ensuring individuals are engaged and retained in specialized intervention services. Individuals also face numerous, and highly impactful, decisions during this period. They are required to navigate complex tasks (finding employment, securing housing), often with limited financial and social supports. Of particular concern, recent research suggests that the reentry period, often characterized by instability and limited resources, may reinforce a decision-making approach that favors meeting immediate needs relative to engaging in long-term planning. This focus on attaining smaller but immediately available rewards relative to larger, delayed, rewards (known as delay discounting), in turn, has been associated with a number of negative health outcomes, including substance use and poor treatment outcomes (higher dropout and lower motivation). In other words, the reentry context may create an environment which reinforces individuals' tendencies to engage in short-term, reward-seeking behaviors (e.g. substance use, skipping treatment appointments) at a time when their decisions have highly significant consequences (relapse, recidivism). This study will examine the efficacy of implementing a low-cost, brief intervention (Episodic Future Thinking) targeting the reduction of delay discounting with the reentry population to inform broader public health efforts aimed at reducing substance misuse and improvements in treatment outcomes.
- Conditions
- Behavior, Health
- Being tested
- Elongating Time HOrizons for Reentry (ETHoR), Standardized Episodic Thinking (SET)
- Keywords
- delay discounting, episodic future thinking, returning citizen, substance use recovery
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elongating Time HOrizons for Reentry (ETHoR)Behavioural
Also called Episodic Future Thinking (EFT)
The adapted episodic future thinking (EFT) intervention will focus on generation of vivid, substance-free, rewarding events that could happen in an incarceration free future.
Standardized Episodic Thinking (SET)Behavioural
In the standardized episodic thinking (SET) condition, the participant will instead describe in vivid details events that have occurred in the recent past.
| Study group | Role | What they receive |
|---|---|---|
| Elongating Time HOrizons for Reentry (ETHoR) | Experimental | Episodic Future Thinking (EFT) utilizes participant-generated descriptions of future events to elongate an individual's temporal horizon. In EFT paradigms, the participant is asked to create and envision vivid descriptions of specific, positively valanced, events that could happen in the future. Recent research suggests that directing EFTs to focus on specific goals (i.e. evoking images of oneself engaging in activities consistent with a desired future outcome) are associated with stronger decreases in undesirable health behaviors. Thus, as part of the ETHoR condition, participants will be asked to verbally describe and imagine four specific events reflecting positive activities in which the participant engages in substance and incarceration-free activities, corresponding to predetermined future timepoints. The PRC will encourage participants to include as many contextual and emotional details as possible. Receives: Behavioral: Elongating Time HOrizons for Reentry (ETHoR) |
| Standardized Recent Thinking (ERT) | Active comparator | Individuals in the control group utilizes SET; an approach that controls for activation of episodic thinking but does not engage prospection (the hypothesized mechanism of episodic future thinking, future outcome) are associated with stronger decreases in undesirable health behaviors. Thus, as part of the SET condition, participants will be asked to verbally describe and imagine four current events reflecting positive activities in which the participant engages in substance and incarceration-free activities, corresponding to current experiences. The PRC will encourage participants to include as many contextual and emotional details as possible. Receives: Behavioral: Standardized Episodic Thinking (SET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Delay Discounting 5 Trial Adjusted Measure
The computer based adjusting amount discounting task uses an adjusting algorithm to determine the amount of immediately available money that is equivalent to a large sum that is delayed by seven discrete durations of time presented in a randomized order (i.e., 1 day, 1 week, 1 month, 6 months, 1 year, 5 years, and 25 years). At each delay, a choice is first presented between the delayed larger sum and a smaller sum available immediately. For each trial, the position of the delayed and immediate amounts are randomly assigned and the participant chooses the preferred option by pressing the corresponding response button.
Measured: Baseline and up to 3 months post-intervention
Change in Consideration of Future Consequences Scale
The Consideration of Future Consequences Scale1 (CFCS-14) is a 14-item self-report questionnaire that assesses active consideration of longer-term implications of an individual's actions. Lower scores on the CFCS-14 are associated with a greater focus on immediate needs and have been found to be associated with less engagement in health behaviors1819 and greater substance use. The measure has been used extensively among adult samples and demonstrates strong reliability and validity. Research suggests modest but significant correlations with the MCQ.
Measured: Baseline and up to 3 months post-intervention
Secondary outcomes (2)
Change in Short Michigan Alcohol Screening Test (SMAST)
The SMAST is a brief questionnaire consisting of 13 items. It can be completed in just a few minutes and is designed for individuals with a reading level equivalent to that of a 7th grader. This assessment tool was derived from the Michigan Alcoholism Screening Test and has been found to be a reliable diagnostic tool to detect at-risk alcohol use, alcohol abuse, or alcoholism. The evaluation data suggests its effectiveness, with no notable occurrence of false positives.
Measured: Baseline and up to 3 months post-intervention
Change in Drug Abuse Screen Test (DAST)
The DAST offer a concise self-report tool for screening populations, identifying clinical cases, and researching treatment effectiveness related to drug abuse. It is applicable for use with both adults and older adolescents. The DAST-10 provides a numerical gauge of the extent of drug abuse-related consequences. Administering the assessment takes around 5 minutes Condensed from its longer counterpart of 28 items, the DAST-10 comprises 10 self-report items.
Measured: Baseline and up to 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start14 Nov 2023
- Primary completion31 Dec 2024
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (68)Papers the sponsor has linked to this study.
- Other trials for Behavior, HealthStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Detroit Recovery Project INC, Michigan State University, University of Kansas
- Responsible party
- Principal investigator, Julia Felton, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119503
- Sponsor's protocol ID
- JRCT: 16686-01
- Status last verified
- Feb 2025
- First submitted
- 25 Oct 2023
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zeng S, Minton TD. Jail Inmates in 2019. Bureau of Justice Statistics. Accessed July 15, 2022. https://bjs.ojp.gov/library/publications/jail-inmates-2019
Loeffler CE, Nagin DS. The Impact of Incarceration on Recidivism. Annu Rev Criminol. 2022;5(1):133-152. doi:10.1146/annurev-criminol-030920-112506
NIDA. Criminal Justice DrugFacts. National Institute on Drug Abuse. Published June 1, 2020. Accessed July 11, 2022. https://nida.nih.gov/publications/drugfacts/criminal-justice
Binswanger IA, Blatchford PJ, Mueller SR, Stern MF. Mortality after prison release: opioid overdose and other causes of death, risk factors, and time trends from 1999 to 2009. Ann Intern Med. 2013 Nov 5;159(9):592-600. doi: 10.7326/0003-4819-159-9-201311050-00005.
PubMed 24189594Pizzicato LN, Drake R, Domer-Shank R, Johnson CC, Viner KM. Beyond the walls: Risk factors for overdose mortality following release from the Philadelphia Department of Prisons. Drug Alcohol Depend. 2018 Aug 1;189:108-115. doi: 10.1016/j.drugalcdep.2018.04.034. Epub 2018 Jun 5.
PubMed 29908410Garland B, Wodahl EJ, Mayfield J. Prisoner Reentry in a Small Metropolitan Community: Obstacles and Policy Recommendations. Criminal Justice Policy Review. 2011;22(1):90-110. doi:10.1177/0887403409359804
Jonson CL, Cullen FT. Prisoner reentry programs. Crime and justice. 2015;44(1):517-575.
Solomon AL. From prison to work: The employment dimensions of prisoner reentry. Published online 2004.
Hattery AJ, Smith E. Prisoner Reentry and Social Capital: The Long Road to Reintegration. Lexington Books; 2010.
Grieb SM, Crawford A, Fields J, Smith H, Harris R, Matson P. "The stress will kill you": prisoner reentry as experienced by family members and the urgent need for support services. J Health Care Poor Underserved. 2014 Aug;25(3):1183-200. doi: 10.1353/hpu.2014.0118.
PubMed 25130233Amso D, Lynn A. Distinctive Mechanisms of Adversity and Socioeconomic Inequality in Child Development: A Review and Recommendations for Evidence-Based Policy. Policy Insights Behav Brain Sci. 2017;4(2):139-146. doi: 10.1177/2372732217721933. Epub 2017 Jul 25.
PubMed 30345346Sheridan MA, Peverill M, Finn AS, McLaughlin KA. Dimensions of childhood adversity have distinct associations with neural systems underlying executive functioning. Dev Psychopathol. 2017 Dec;29(5):1777-1794. doi: 10.1017/S0954579417001390.
PubMed 29162183Wesarg C, Akker ALVD, Oei NYL, Hoeve M, Wiers RW. Identifying pathways from early adversity to psychopathology: A review on dysregulated HPA axis functioning and impaired self-regulation in early childhood. European Journal of Developmental Psychology. 2020;17(6):808-827. doi:10.1080/17405629.2020.1748594
Friedel E, Schlagenhauf F, Beck A, Dolan RJ, Huys QJ, Rapp MA, Heinz A. The effects of life stress and neural learning signals on fluid intelligence. Eur Arch Psychiatry Clin Neurosci. 2015 Feb;265(1):35-43. doi: 10.1007/s00406-014-0519-3. Epub 2014 Aug 21.
PubMed 25142177Mani A, Mullainathan S, Shafir E, Zhao J. Poverty impedes cognitive function. Science. 2013 Aug 30;341(6149):976-80. doi: 10.1126/science.1238041.
PubMed 23990553
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Delivered Episodic Future Thinking to Improve MOUD Treatment Engagement Among Returning Citizens - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06119503
- Acronym / sponsor ID
- JRCT: 16686-01
- Conditions
- Behavior, Health
- Keywords
- delay discounting, episodic future thinking, returning citizen, substance use recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- Detroit Recovery Project INC, Michigan State University, University of Kansas
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 7 Nov 2023 (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.
The goal of this study is to examine the effectiveness of a brief, episodic future thinking (EFT) intervention in a substance use treatment setting serving returning citizens with substance use disorders (SUD).
The main questions it aims to answer are:
- Determine preliminary implementation potential of the EFT intervention, including acceptability and feasibility of conducting the intervention.
- Examine the preliminary effectiveness of this approach, with a specific focus on patient outcomes, including changes in delay discounting, treatment retention, treatment motivation, and substance use.
Participants will be asked to participant in pre and post assessment questionnaires, participate in a single-episode brief intervention followed by tailored phone call follow-ups.
Detailed description
Returning citizens with substance use disorders (SUD) are at the greatest risk for overdose in the first two weeks following the transition from incarceration. Thus, the reentry period is of specific importance for ensuring individuals are engaged and retained in specialized intervention services. Individuals also face numerous, and highly impactful, decisions during this period. They are required to navigate complex tasks (finding employment, securing housing), often with limited financial and social supports. Of particular concern, recent research suggests that the reentry period, often characterized by instability and limited resources, may reinforce a decision-making approach that favors meeting immediate needs relative to engaging in long-term planning. This focus on attaining smaller but immediately available rewards relative to larger, delayed, rewards (known as delay discounting), in turn, has been associated with a number of negative health outcomes, including substance use and poor treatment outcomes (higher dropout and lower motivation). In other words, the reentry context may create an environment which reinforces individuals' tendencies to engage in short-term, reward-seeking behaviors (e.g. substance use, skipping treatment appointments) at a time when their decisions have highly significant consequences (relapse, recidivism). This study will examine the efficacy of implementing a low-cost, brief intervention (Episodic Future Thinking) targeting the reduction of delay discounting with the reentry population to inform broader public health efforts aimed at reducing substance misuse and improvements in treatment outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elongating Time HOrizons for Reentry (ETHoR) | Experimental | Behavioral: Elongating Time HOrizons for Reentry (ETHoR)Episodic Future Thinking (EFT) utilizes participant-generated descriptions of future events to elongate an individual's temporal horizon. In EFT paradigms, the participant is asked to create and envision vivid descriptions of specific, positively valanced, events that could happen in the future. Recent research suggests that directing EFTs to focus on specific goals (i.e. evoking images of oneself engaging in activities consistent with a desired future outcome) are associated with stronger decreases in undesirable health behaviors. Thus, as part of the ETHoR condition, participants will be asked to verbally describe and imagine four specific events reflecting positive activities in which the participant engages in substance and incarceration-free activities, corresponding to predetermined future timepoints. The PRC will encourage participants to include as many contextual and emotional details as possible. |
| Standardized Recent Thinking (ERT) | Active comparator | Behavioral: Standardized Episodic Thinking (SET)Individuals in the control group utilizes SET; an approach that controls for activation of episodic thinking but does not engage prospection (the hypothesized mechanism of episodic future thinking, future outcome) are associated with stronger decreases in undesirable health behaviors. Thus, as part of the SET condition, participants will be asked to verbally describe and imagine four current events reflecting positive activities in which the participant engages in substance and incarceration-free activities, corresponding to current experiences. The PRC will encourage participants to include as many contextual and emotional details as possible. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least 18 years of age
- Experience in an incarceration setting within 12 months
- Identify as an individual in substance use recovery
- Willing to participate in the study
- Able to participate in written assessments and an intervention conducted in English
Key exclusion criteria (2 listed)
- Individuals' ineligible or unwilling to participate in study activities and assessments
- Self-reporting of active and untreated psychosis
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 |
|---|---|---|
| Elongating Time HOrizons for Reentry (ETHoR)Also: Episodic Future Thinking (EFT)The adapted episodic future thinking (EFT) intervention will focus on generation of vivid, substance-free, rewarding events that could happen in an incarceration free future. | Behavioural | Elongating Time HOrizons for Reentry (ETHoR) |
| Standardized Episodic Thinking (SET)In the standardized episodic thinking (SET) condition, the participant will instead describe in vivid details events that have occurred in the recent past. | Behavioural | Standardized Recent Thinking (ERT) |
Primary outcome
Change in Delay Discounting 5 Trial Adjusted Measure
Time frame: Baseline and up to 3 months post-intervention
The computer based adjusting amount discounting task uses an adjusting algorithm to determine the amount of immediately available money that is equivalent to a large sum that is delayed by seven discrete durations of time presented in a randomized order (i.e., 1 day, 1 week, 1 month, 6 months, 1 year, 5 years, and 25 years). At each delay, a choice is first presented between the delayed larger sum and a smaller sum available immediately. For each trial, the position of the delayed and immediate amounts are randomly assigned and the participant chooses the preferred option by pressing the corresponding response button.
Change in Consideration of Future Consequences Scale
Time frame: Baseline and up to 3 months post-intervention
The Consideration of Future Consequences Scale1 (CFCS-14) is a 14-item self-report questionnaire that assesses active consideration of longer-term implications of an individual's actions. Lower scores on the CFCS-14 are associated with a greater focus on immediate needs and have been found to be associated with less engagement in health behaviors1819 and greater substance use. The measure has been used extensively among adult samples and demonstrates strong reliability and validity. Research suggests modest but significant correlations with the MCQ.
2 secondary outcomes
Change in Short Michigan Alcohol Screening Test (SMAST)
Time frame: Baseline and up to 3 months post-intervention
Change in Drug Abuse Screen Test (DAST)
Time frame: Baseline and up to 3 months post-intervention
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 25 Feb 2025.
- BackgroundZeng S, Minton TD. Jail Inmates in 2019. Bureau of Justice Statistics. Accessed July 15, 2022. https://bjs.ojp.gov/library/publications/jail-inmates-2019
- BackgroundLoeffler CE, Nagin DS. The Impact of Incarceration on Recidivism. Annu Rev Criminol. 2022;5(1):133-152. doi:10.1146/annurev-criminol-030920-112506
- BackgroundNIDA. Criminal Justice DrugFacts. National Institute on Drug Abuse. Published June 1, 2020. Accessed July 11, 2022. https://nida.nih.gov/publications/drugfacts/criminal-justice
- Background: PubMed 24189594Binswanger IA, Blatchford PJ, Mueller SR, Stern MF. Mortality after prison release: opioid overdose and other causes of death, risk factors, and time trends from 1999 to 2009. Ann Intern Med. 2013 Nov 5;159(9):592-600. doi: 10.7326/0003-4819-159-9-201311050-00005.
- Background: PubMed 29908410Pizzicato LN, Drake R, Domer-Shank R, Johnson CC, Viner KM. Beyond the walls: Risk factors for overdose mortality following release from the Philadelphia Department of Prisons. Drug Alcohol Depend. 2018 Aug 1;189:108-115. doi: 10.1016/j.drugalcdep.2018.04.034. Epub 2018 Jun 5.
- BackgroundGarland B, Wodahl EJ, Mayfield J. Prisoner Reentry in a Small Metropolitan Community: Obstacles and Policy Recommendations. Criminal Justice Policy Review. 2011;22(1):90-110. doi:10.1177/0887403409359804
- BackgroundJonson CL, Cullen FT. Prisoner reentry programs. Crime and justice. 2015;44(1):517-575.
- BackgroundSolomon AL. From prison to work: The employment dimensions of prisoner reentry. Published online 2004.
- BackgroundHattery AJ, Smith E. Prisoner Reentry and Social Capital: The Long Road to Reintegration. Lexington Books; 2010.
- Background: PubMed 25130233Grieb SM, Crawford A, Fields J, Smith H, Harris R, Matson P. "The stress will kill you": prisoner reentry as experienced by family members and the urgent need for support services. J Health Care Poor Underserved. 2014 Aug;25(3):1183-200. doi: 10.1353/hpu.2014.0118.
- Background: PubMed 30345346Amso D, Lynn A. Distinctive Mechanisms of Adversity and Socioeconomic Inequality in Child Development: A Review and Recommendations for Evidence-Based Policy. Policy Insights Behav Brain Sci. 2017;4(2):139-146. doi: 10.1177/2372732217721933. Epub 2017 Jul 25.
- Background: PubMed 29162183Sheridan MA, Peverill M, Finn AS, McLaughlin KA. Dimensions of childhood adversity have distinct associations with neural systems underlying executive functioning. Dev Psychopathol. 2017 Dec;29(5):1777-1794. doi: 10.1017/S0954579417001390.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elongating Time HOrizons for Reentry (ETHoR) and Standardized Episodic Thinking (SET) in people with Behavior, Health, run by Henry Ford Health System 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 6 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: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Delay Discounting 5 Trial Adjusted Measure (time frame: Baseline and up to 3 months post-intervention). 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 NCT06119503, which also lists 68 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 25 Feb 2025.