Youth IncarcerationNCT03556618
A Pilot Trial of a Network Intervention for Youth After Incarceration
A study testing Whole Person Care (WPC) Reentry Program - Pre & Post Release services in people with Youth Incarceration and Health Care Utilization, run by University of California, Los Angeles at 1 site in United States.
Trial summary
A vicious cycle exists between adolescent substance use disorders and youth incarceration. Re-wiring adolescent social networks during community reentry after incarceration can potentially break the cycle of adolescent substance use and youth incarceration. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Youth Incarceration, Health Care Utilization
- What is being tested?
- Whole Person Care (WPC) Reentry Program - Pre & Post Release services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2020to 31 Oct 2023
- 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 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Inclusion criteria for youth exiting the adult justice system:
- Recipient of WPC pre-release reentry intervention (determined by Los Angeles County)
- Ages 18-24
- Fluent in English or Spanish
Exclusion criteria for youth exiting the adult justice system:
- Not receiving WPC pre-release reentry intervention (determined by Los Angeles County)
- Severe cognitive delay
- Unable to complete surveys in English or Spanish
Trial locations and contacts
1 site in 1 country.
United States1 site
Los Angeles County Jails
Los Angeles, California, 90012
About this study
A vicious cycle exists between adolescent substance use disorders and youth incarceration. Re-wiring adolescent social networks during community reentry after incarceration can potentially break the cycle of adolescent substance use and youth incarceration. Social networks influence adolescent substance use and delinquent behavior, yet little is known about how to intervene on social networks to improve health. Community reentry is a key opportunity to re-set youths' social networks and re-direct high-risk youth toward a healthier, more supportive network that can foster drug abstinence and reduce recidivism. The investigators hypothesize that an adult who has successfully navigated reentry can guide youth to rewire their social network by encouraging pro-social relationships, troubleshooting basic barriers to healthcare and social services, and helping create linkages to substance use and mental health treatment services. The goal of this study is to measure the impact of a pilot intervention to address two key barriers to accessing behavioral health treatment among recently incarcerated youth: poor care coordination and need for more positive support from the social network. The proposed study intervention, the Whole Person Care (WPC) Reentry Program, is based on the successful adult Transitions Clinic model, and is being adapted for delivery to transition age youth (TAY) by community partners in the Los Angeles County justice system. WPC community health workers (coaches) will provide recently released inmates a formerly incarcerated adult role model who provides care coordination and social support to facilitate access to needed health services, and who actively intervenes to guide TAY youth toward pro-social peers and adults. The investigators propose a pilot longitudinal study of WPC, using a community-partnered participatory research approach. The primary outcome will be reductions in adolescent substance use in response to the intervention (Aim 1). Secondary outcomes will test whether the intervention increases receipt of behavioral health services, decreases recidivism and mental health symptoms, and improves school and work engagement (Aim 2). Finally, the investigators will examine social networks as a potential mechanism by measuring whether youth receiving the intervention report healthier social networks (lower proportion of peers engaging in risky behaviors and a higher number of supportive adults) than control youth (Aim 3).
Read the detailed description
A vicious cycle exists between adolescent substance use disorders (SUD) and youth incarceration. Untreated SUD, often comorbid with mental health problems, contribute substantially to youth incarceration. Among 51,000 US youth detained annually, 50-88% have SUD. Incarceration itself can exacerbate existing mental health disorders and contribute to future substance use. Following incarceration, reentry back into the community of peers and adults is a challenging juncture and a high risk period for re-engaging in substance use. Finally, relapse on substance use leads to recidivism. Within 3 years of release, 75% of adolescents are re-arrested, with highest risk among youth with SUD.
Re-wiring adolescent social networks during reentry can potentially break the vicious cycle of adolescent substance use and youth incarceration. Social networks powerfully influence adolescent substance use and delinquent behavior, yet little is known about how to intervene on social networks to improve health. In the investigators prior research, the investigators found that incarcerated youth value relationships with supportive adults and peers who can help them succeed in school and stay out of trouble. Most express plans to "stay clean" from drugs and stay away from peers who encourage substance use and delinquent behaviors. Yet, during reentry, many youth re-engage with their previous network of risky peers. Why? The investigators have found that upon reentry, youth who lack sufficient social supports and positive role models default back to previous risky social networks, reinforcing further substance use and other risky behaviors. Community reentry is a key opportunity to re-set social networks and re-direct high-risk youth toward a healthier network that can foster drug abstinence and reduce recidivism. Having an available and supportive adult role model can be transformative for youth after incarceration. The investigators hypothesize that an adult who has successfully navigated reentry can actively guide youth to re-wire their social network by encouraging pro-social relationships, troubleshooting basic barriers to healthcare and social services, and creating linkages to SUD and mental health services, to disrupt the viscous cycle.
This community-partnered study seeks to measure the impact of an innovative pilot intervention, the Whole Person Care (WPC) Reentry Program, a network community health worker (i.e. coach) intervention that addresses two key challenges for recently incarcerated transition age youth (TAY): poor care coordination in the "behavioral health cascade" and need for more positive support from the social network. Los Angeles (LA) County has the largest adult and juvenile justice systems in the US and has implemented the WPC Reentry Program to enhance linkages to community behavioral health services. WPC is based on the successful Transitions Clinic model, an intervention with demonstrated efficacy in linking recently incarcerated adults to needed healthcare and improving health outcomes. The model has yet to be implemented for reentry TAY, but has the potential to be transformative at the critical developmental stage of adolescence, when peer social networks are highly dynamic and youth behaviors can affect lifelong trajectories. WPC community health workers will receive formalized training modeled after the adult Transitions Clinic approach and will serve as a formerly incarcerated adult role model who provides care coordination and social support to facilitate access to needed behavioral health services. Tailored for reentry youth, WPC will also include a social network component whereby coaches are trained to actively guide youth toward pro-social peers and adults. Dr. Barnert has been working closely with LA County and this study capitalizes on a unique opportunity to rigorously study WPC. The investigators hypothesize that (1) WPC will reduce adolescent SUD and recidivism and (2) WPC will demonstrate positive associations with other key markers of healthy reentry (e.g., improved mental health). The investigators further hypothesize that shifts towards healthier social networks will mediate these relationships, a potential mechanism the investigators will test.
The investigators propose a pilot longitudinal study of WPC, using a community-partnered, participatory research approach. Specific aims are to:
- Measure the impact of the WPC network coach intervention targeting recently incarcerated youth on decreasing rates of 30-day use and risky use of marijuana, alcohol, and other drug use.
- Test whether the WPC network coach intervention decreases recidivism, increases receipt of behavioral health services, improves mental health, and enhances school and work engagement.
- Examine whether recently incarcerated youth receiving the WPC intervention report healthier social networks (lower proportion of peers engaging in risky behaviors and a higher number of supportive adults) than those not receiving the intervention.
- Conditions
- Youth Incarceration, Health Care Utilization
- Being tested
- Whole Person Care (WPC) Reentry Program - Pre & Post Release services
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Person Care (WPC) Reentry Program - Pre & Post Release servicesBehavioural
Social network intervention to provide care coordination and social support during youth reentry before release and post-release from jail.
| Study group | Role | What they receive |
|---|---|---|
| Whole Person Care (WPC) Reentry Program - Post-Release | Experimental | In partnership with LA County Health Agency, Dr. Barnert is adapting the successful Transitions Clinic model developed for reentry adults, to assist recently incarcerated transition age youth link to needed health services and reduce substance use disorder relapse and recidivism. This adaption is informed by Dr. Barnert's prior research on the needs of incarcerated adolescents. The intervention, called the "Whole Person Care (WPC) Reentry Program" will consist of community health workers (i.e. network coaches) who are formerly incarcerated and formally trained in care coordination and social network coaching, who interact with justice-involved transition age youth pre- and post-release to increase youths' engagement in community SUD and mental health services. Participants in this branch will include youth exiting the adult justice system (ages 18-24) who receive PRE- and POST-release WPC services. Receives: Behavioral: Whole Person Care (WPC) Reentry Program - Pre & Post Release services |
| Control | No intervention | Participants in the control arm will receive PRE-release services only from Whole Person Care. They will not receive the POST-release WPC community health worker intervention. Participants in this branch will include youth exiting the adult jail system (ages 18-24). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Past-month (30-day) Marijuana Use
Self-reported frequency of past-month (30-day) marijuana use
Measured: 3 months post-release
Frequency of Past-month (30-day) Alcohol Use
Self-reported frequency of past-month (30-day) alcohol use
Measured: 3 months post-release
Secondary outcomes (18)
Frequency of Past-month (30-day) Marijuana Use
Self-reported frequency of past-month (30-day) marijuana use
Measured: 9 months post release
Frequency of Past-month (30-day) Alcohol Use
Self-reported frequency of past-month (30-day) alcohol use
Measured: 9 months post release
Recidivism
Re-arrest since release (self-report and administrative/probation data)
Measured: 3 months post-release
Recidivism
Re-arrest since last survey (self-report and administrative/probation data)
Measured: 9 months post release
Receipt of Behavioral Health Services
receipt of behavioral since release (self-report and verified by administrative/probation data)
Measured: 3 months post-release
Receipt of Behavioral Health Services
receipt of behavioral since last survey (self-report and verified by administrative/probation data)
Measured: 9 months post-release
Mental Health
self-reported presence of diagnosis of a mental health disorder (will be verified by administrative/probation data)
Measured: 3 months post release
Mental Health
self-reported presence of diagnosis of a mental health disorder at follow-up (will be verified by administrative/probation data)
Measured: 9 months post release
Substance Use Disorders
self-reported presence or diagnosis of substance use disorder at follow-up (will be verified by administrative/probation data)
Measured: 3 months post release
Substance Use Disorders
self-reported presence or diagnosis of substance use disorder at follow-up (will be verified by administrative/probation data)
Measured: 9 months post release
Medications
self-reported medication or prescription at follow-up (will be verified by administrative/probation data)
Measured: 3 months post release
Medications
self-reported medication or prescription at follow-up (will be verified by administrative/probation data)
Measured: 9 months post release
Delinquency
number of arrest since release (will be verified by administrative/probation data)
Measured: 3 months post release
Delinquency
number of arrest since last survey (will be verified by administrative/probation data)
Measured: 9 months post release
Attitudes Towards WPC Reentry Intervention (WPC Reentry Participant Response Tool)
Liked intervention; recommend to a friend. Assessed via WPC Reentry Participant Response Tool. Includes 3 items, assessed via 7-point Likert scale.
Measured: 3 months post release
Attitudes Towards WPC Reentry Intervention (WPC Reentry Participant Response Tool)
Liked intervention; recommend to a friend. Assessed via WPC Reentry Participant Response Tool. Includes 3 items, assessed via 7-point Likert scale.
Measured: 9 months post release
Psychiatric Hospitalizations
psychiatric hospitalizations since release (self-report and health records data)
Measured: 3 months post release
Psychiatric Hospitalizations
psychiatric hospitalizations since last survey (self-report and health records data)
Measured: 9 months post release
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start2 Mar 2020
- Primary completion16 Dec 2021
- Study completion31 Oct 2023
Why it stopped: It was not feasible to study the WPC intervention as a clinical trial due to disruptions caused by COVID-19.
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.
- Other trials for Youth IncarcerationStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Barnert, MD, MPH, MS, University of California, Los Angeles
- Investigators
- Elizabeth S Barnert, MD, MPH, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556618
- Sponsor's protocol ID
- K23DA045747-01
- Status last verified
- Feb 2024
- First submitted
- 18 May 2018
- Last updated
- 27 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available to other researchers. The participants, justice-involved youth, are a vulnerable population and we do not currently have permission to share their IPD.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of a Network Intervention for Youth After Incarceration
- ClinicalTrials.gov ID
- NCT03556618
- Acronym / sponsor ID
- K23DA045747-01
- Conditions
- Youth Incarceration, Health Care Utilization
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It was not feasible to study the WPC intervention as a clinical trial due to disruptions caused by COVID-19.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 16 Dec 2021 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 14 Jun 2018 (actual)
- Results
- Posted 27 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A vicious cycle exists between adolescent substance use disorders and youth incarceration. Re-wiring adolescent social networks during community reentry after incarceration can potentially break the cycle of adolescent substance use and youth incarceration. Social networks influence adolescent substance use and delinquent behavior, yet little is known about how to intervene on social networks to improve health. Community reentry is a key opportunity to re-set youths' social networks and re-direct high-risk youth toward a healthier, more supportive network that can foster drug abstinence and reduce recidivism. The investigators hypothesize that an adult who has successfully navigated reentry can guide youth to rewire their social network by encouraging pro-social relationships, troubleshooting basic barriers to healthcare and social services, and helping create linkages to substance use and mental health treatment services. The goal of this study is to measure the impact of a pilot intervention to address two key barriers to accessing behavioral health treatment among recently incarcerated youth: poor care coordination and need for more positive support from the social network. The proposed study intervention, the Whole Person Care (WPC) Reentry Program, is based on the successful adult Transitions Clinic model, and is being adapted for delivery to transition age youth (TAY) by community partners in the Los Angeles County justice system. WPC community health workers (coaches) will provide recently released inmates a formerly incarcerated adult role model who provides care coordination and social support to facilitate access to needed health services, and who actively intervenes to guide TAY youth toward pro-social peers and adults. The investigators propose a pilot longitudinal study of WPC, using a community-partnered participatory research approach. The primary outcome will be reductions in adolescent substance use in response to the intervention (Aim 1). Secondary outcomes will test whether the intervention increases receipt of behavioral health services, decreases recidivism and mental health symptoms, and improves school and work engagement (Aim 2). Finally, the investigators will examine social networks as a potential mechanism by measuring whether youth receiving the intervention report healthier social networks (lower proportion of peers engaging in risky behaviors and a higher number of supportive adults) than control youth (Aim 3).
Detailed description
A vicious cycle exists between adolescent substance use disorders (SUD) and youth incarceration. Untreated SUD, often comorbid with mental health problems, contribute substantially to youth incarceration. Among 51,000 US youth detained annually, 50-88% have SUD. Incarceration itself can exacerbate existing mental health disorders and contribute to future substance use. Following incarceration, reentry back into the community of peers and adults is a challenging juncture and a high risk period for re-engaging in substance use. Finally, relapse on substance use leads to recidivism. Within 3 years of release, 75% of adolescents are re-arrested, with highest risk among youth with SUD.
Re-wiring adolescent social networks during reentry can potentially break the vicious cycle of adolescent substance use and youth incarceration. Social networks powerfully influence adolescent substance use and delinquent behavior, yet little is known about how to intervene on social networks to improve health. In the investigators prior research, the investigators found that incarcerated youth value relationships with supportive adults and peers who can help them succeed in school and stay out of trouble. Most express plans to "stay clean" from drugs and stay away from peers who encourage substance use and delinquent behaviors. Yet, during reentry, many youth re-engage with their previous network of risky peers. Why? The investigators have found that upon reentry, youth who lack sufficient social supports and positive role models default back to previous risky social networks, reinforcing further substance use and other risky behaviors. Community reentry is a key opportunity to re-set social networks and re-direct high-risk youth toward a healthier network that can foster drug abstinence and reduce recidivism. Having an available and supportive adult role model can be transformative for youth after incarceration. The investigators hypothesize that an adult who has successfully navigated reentry can actively guide youth to re-wire their social network by encouraging pro-social relationships, troubleshooting basic barriers to healthcare and social services, and creating linkages to SUD and mental health services, to disrupt the viscous cycle.
This community-partnered study seeks to measure the impact of an innovative pilot intervention, the Whole Person Care (WPC) Reentry Program, a network community health worker (i.e. coach) intervention that addresses two key challenges for recently incarcerated transition age youth (TAY): poor care coordination in the "behavioral health cascade" and need for more positive support from the social network. Los Angeles (LA) County has the largest adult and juvenile justice systems in the US and has implemented the WPC Reentry Program to enhance linkages to community behavioral health services. WPC is based on the successful Transitions Clinic model, an intervention with demonstrated efficacy in linking recently incarcerated adults to needed healthcare and improving health outcomes. The model has yet to be implemented for reentry TAY, but has the potential to be transformative at the critical developmental stage of adolescence, when peer social networks are highly dynamic and youth behaviors can affect lifelong trajectories. WPC community health workers will receive formalized training modeled after the adult Transitions Clinic approach and will serve as a formerly incarcerated adult role model who provides care coordination and social support to facilitate access to needed behavioral health services. Tailored for reentry youth, WPC will also include a social network component whereby coaches are trained to actively guide youth toward pro-social peers and adults. Dr. Barnert has been working closely with LA County and this study capitalizes on a unique opportunity to rigorously study WPC. The investigators hypothesize that (1) WPC will reduce adolescent SUD and recidivism and (2) WPC will demonstrate positive associations with other key markers of healthy reentry (e.g., improved mental health). The investigators further hypothesize that shifts towards healthier social networks will mediate these relationships, a potential mechanism the investigators will test.
The investigators propose a pilot longitudinal study of WPC, using a community-partnered, participatory research approach. Specific aims are to:
- Measure the impact of the WPC network coach intervention targeting recently incarcerated youth on decreasing rates of 30-day use and risky use of marijuana, alcohol, and other drug use.
- Test whether the WPC network coach intervention decreases recidivism, increases receipt of behavioral health services, improves mental health, and enhances school and work engagement.
- Examine whether recently incarcerated youth receiving the WPC intervention report healthier social networks (lower proportion of peers engaging in risky behaviors and a higher number of supportive adults) than those not receiving the intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole Person Care (WPC) Reentry Program - Post-Release | Experimental | Behavioral: Whole Person Care (WPC) Reentry Program - Pre & Post Release servicesIn partnership with LA County Health Agency, Dr. Barnert is adapting the successful Transitions Clinic model developed for reentry adults, to assist recently incarcerated transition age youth link to needed health services and reduce substance use disorder relapse and recidivism. This adaption is informed by Dr. Barnert's prior research on the needs of incarcerated adolescents. The intervention, called the "Whole Person Care (WPC) Reentry Program" will consist of community health workers (i.e. network coaches) who are formerly incarcerated and formally trained in care coordination and social network coaching, who interact with justice-involved transition age youth pre- and post-release to increase youths' engagement in community SUD and mental health services. Participants in this branch will include youth exiting the adult justice system (ages 18-24) who receive PRE- and POST-release WPC services. |
| Control | No intervention | –Participants in the control arm will receive PRE-release services only from Whole Person Care. They will not receive the POST-release WPC community health worker intervention. Participants in this branch will include youth exiting the adult jail system (ages 18-24). |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Whole Person Care (WPC) Reentry Program - Pre & Post Release servicesSocial network intervention to provide care coordination and social support during youth reentry before release and post-release from jail. | Behavioural | Whole Person Care (WPC) Reentry Program - Post-Release |
Primary outcome
Frequency of Past-month (30-day) Marijuana Use
Time frame: 3 months post-release
Self-reported frequency of past-month (30-day) marijuana use
Frequency of Past-month (30-day) Alcohol Use
Time frame: 3 months post-release
Self-reported frequency of past-month (30-day) alcohol use
18 secondary outcomes
Frequency of Past-month (30-day) Marijuana Use
Time frame: 9 months post release
Frequency of Past-month (30-day) Alcohol Use
Time frame: 9 months post release
Recidivism
Time frame: 3 months post-release
Recidivism
Time frame: 9 months post release
Receipt of Behavioral Health Services
Time frame: 3 months post-release
Receipt of Behavioral Health Services
Time frame: 9 months post-release
Mental Health
Time frame: 3 months post release
Mental Health
Time frame: 9 months post release
Substance Use Disorders
Time frame: 3 months post release
Substance Use Disorders
Time frame: 9 months post release
Medications
Time frame: 3 months post release
Medications
Time frame: 9 months post release
Delinquency
Time frame: 3 months post release
Delinquency
Time frame: 9 months post release
Attitudes Towards WPC Reentry Intervention (WPC Reentry Participant Response Tool)
Time frame: 3 months post release
Attitudes Towards WPC Reentry Intervention (WPC Reentry Participant Response Tool)
Time frame: 9 months post release
Psychiatric Hospitalizations
Time frame: 3 months post release
Psychiatric Hospitalizations
Time frame: 9 months post release
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available to other researchers. The participants, justice-involved youth, are a vulnerable population and we do not currently have permission to share their IPD.
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.
Elizabeth S Barnert, MD, MPH principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Person Care (WPC) Reentry Program - Pre & Post Release services in people with Youth Incarceration and Health Care Utilization, run by University of California, Los Angeles 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?
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: stopped early, as of the sponsor's last update on 27 Mar 2024. 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 27 Mar 2024). 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?
Frequency of Past-month (30-day) Marijuana Use (time frame: 3 months post-release). 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?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.