Substance Use DisordersNCT05081934
Feasibility, Acceptability and Preliminary Treatment Effects of A-CRA for Youth in Compulsory Institutional Care
A study testing A-CRA and TAU in people with Substance Use Disorders and Criminal Behavior, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Substance abuse and criminal behavior are increasing among adolescents in Sweden. The Swedish National Board of Institutional Care, SiS, provides institutional care on basis of the Swedish laws Care of Young Persons (Special Provisions) Act, LVU, Care of Substance Abusers (Special Provisions) Act, LVM, Secure Youth… Read more about this study
- Who is it for?
- Ages 16 to 21 years
- Conditions the study is for
- Substance Use Disorders, Criminal Behavior
- What is being tested?
- A-CRA and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSweden
- Study dates
- 16 Feb 2022to 31 Dec 2023
- 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 16 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 16-21, placed in institutional care (SiS), with substance use disorder and criminal, violent or destructive behavior, willing and able to undergo A-CRA during their placement.
- Ability to read and understand informed consent.
Who cannot join
- Severe cognitive or psychiatric condition that obstructs ability to provide informed consent or to undergo assessment or interventions.
- Serious somatic condition requiring acute medical attention.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet.
Stockholm, Stockholm County
About this study
Official title: Feasibility, Acceptability and Preliminary Treatment Effects of Adolescent Community Reinforcement Approach, A-CRA, for Youth in Compulsory Institutional Care
Substance abuse and criminal behavior are increasing among adolescents in Sweden. The Swedish National Board of Institutional Care, SiS, provides institutional care on basis of the Swedish laws Care of Young Persons (Special Provisions) Act, LVU, Care of Substance Abusers (Special Provisions) Act, LVM, Secure Youth Care Act, LSU. Treatment is provided at locked youth residential homes. The Adolescent Community Reinforcement Approach, A-CRA, an empirically supported substance use treatment, promotes long-term abstinence, increases social stability and decreases depression and other co-morbid psychiatric problems. However, A-CRA has mostly been delivered and evaluated within outpatient care. It is unclear whether A-CRA is as effective when delivered in compulsory care where many adolescents with severe substance use disorder and criminal behavior receive treatment. This study is the first part of a larger project with the overall objective to evaluate and adjust A-CRA to the compulsory care provided at National Board of Institutional Care (Statens institutionsstyrelse, SiS) for justice-involved youth. The aim of this first part is to examine feasibility, acceptability and preliminary effects of A-CRA when provided in institutional care (SiS). Furthermore, to explore experiences of undergoing and delivering A-CRA in the institutional setting. Data collected from this study will be used for improvement of a coming full scale randomized controlled trial planned for 2022. Expected results are that A-CRA is feasible in the institutional environment, that A-CRA is perceived as helpful and acceptable by therapists and adolescents, that planned procedures are feasible and data collection and recruitment works satisfactorily.
Read the detailed description
The primary objective of this study is to evaluate the feasibility, acceptability and preliminary effects of the empirically supported treatment A-CRA when adjusted to, and delivered in, the institutional care of SiS. Furthermore, to increase pro-social behavior/attitudes and psychological flexibility, to improve mental health and to decrease criminal behavior and substance abuse in youth suffering from substance use disorder and/or disruptive behaviors. This study consists of a qualitative and a quantitative part 1) semi-structured interviews with adolescents and therapists involved in treatment to explore experiences 2) a pilot study to evaluate acceptability, feasibility and preliminary effects of A-CRA. Treatment type and dose (number of sessions received and length of sessions) are registered to enable future analyzes. Acceptability (perceived helpfulness and comprehensibility) is measured using a 7-point Likert-scale, ranging from 1 (not at all helpful) to 7 (very helpful).
Adolescents are randomized to either standard care alone or standard care with the addition of A-CRA. Standard care is defined as the interventions and treatments adolescents are usually offered and undergo in institutional care. These are Motivational Interviewing, MI, Cognitive Behavioral Therapy, CBT, Aggression Replacement Therapy, ART or Acceptance and Commitment Therapy, ACT. This will be further specified and registered in the initial phase of the study, in collaboration with SiS. Randomization takes place at the individual level with even allocation to the groups. Quantitative measurements take place before, during and after treatment as well as follow up once a month for six months. Potential adverse events will be collected after treatment completion using open questions.
- Conditions
- Substance Use Disorders, Criminal Behavior
- Being tested
- A-CRA, TAU
- Medical subject headings
- Substance-Related Disorders, Criminal Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A-CRABehavioural
12-14 weekly sessions of A-CRA, a behavioral treatment for youth suffering from substance use disorder and co-occurring problems. The average time for a placement within SiS is for boys 5,9 months and for girls 4,5 months. To further adjust A-CRA to the closed institutional care, frequency of sessions may be increased to twice a week. This is to facilitate maintaining of focus in treatment and closely follow treatment progress. Treatment consists of 18 procedures that aim to reduce problematic behaviors and increase constructive behaviors. Example of procedures are functional analysis of substance use behavior, functional analysis of prosocial behavior, increasing prosocial activities, drink/drug refusal, relapse prevention, anger management and caregiver sessions. Procedures are combined and tailored to youth individual goals and needs.
TAUBehavioural
Standard care is defined as the interventions and treatments adolescents are usually offered and undergo in institutional care. These are Motivational Interviewing, MI, Cognitive Behavioral Therapy, CBT, Aggression Replacement Therapy, ART or Acceptance and Commitment Therapy, ACT. This will be further specified and registered in the initial phase of the study, in collaboration with SiS.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual, TAU | Active comparator | TAU: Interventions and treatments usually offered and delivered in institutional care. For example, Motivational Interviewing, MI, Cognitive Behavioral Therapy, CBT, Aggression Replacement Therapy, ART or Acceptance and Commitment Therapy, ACT. Further specification of TAU will be made in collaboration with the institutions included in the trial. Receives: Behavioral: TAU |
| TAU + A-CRA | Experimental | Behavioral: A-CRA, a 12-14 weekly sessions long behavioral treatment for youth (ages 12-25) suffering from substance use disorder and co-occurring problems, i.e. criminal behavior. The aim is to increase constructive behavior that reduces the need of substances and creates a context where it is rewarding to stay sober. Individual functional analyses, goals and needs guides treatment planning and interventions.
TAU: interventions and treatments usually offered and delivered in institutional care. For example, Motivational Interviewing, MI, Cognitive Behavioral Therapy, CBT, Aggression Replacement Therapy, ART or Acceptance and Commitment Therapy, ACT. Further specification of TAU will be made in collaboration with the institutions included in the trial. Receives: Behavioral: A-CRA; Behavioral: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attrition
Attrition defined as participants discontinuing treatment and assessments.
Measured: During treatment and at follow up 6 months.
Inclusion rate.
Proportion of youth accepting to participate after being informed about randomization and offered treatment.
Measured: 0 weeks.
Treatment completion.
Percentage of treatment completers defined as participants who underwent all planned A-CRA modules.
Measured: Immediately after completion.
Secondary outcomes (14)
Completed treatment sessions
Proportion of treatment sessions completed in TAU + A-CRA compared to TAU.
Measured: Registered weekly
Length of treatment sessions
Average length of treatment sessions in TAU + A-CRA compared to TAU.
Measured: Registered after every session
Treatment period
Defined as number of weeks from treatment initiation to treatment completion.
Measured: 0 weeks to treatment completion.
Acceptability of treatment
Acceptability is measured using a 7-point Likert-scale, ranging from 1 (not at all helpful) to 7 (very helpful).
Measured: Post treatment.
Depression, anxiety and stress
Depression Anxiety Stress Scale-21 (DASS-21; Antony, Bieling, Cox, Enns, \& Swinson, 1998), a self-assessment scale with three subscales.
Measured: 0 weeks, 7 weeks, 14 weeks and at follow up 6 months after treatment.
Pro-social behavior
Prosocial Tendencies Measure (PTM; Carlo \& Randall, 2002), a self-assessment scale measuring pro-social behavior in six domains, such as altruistic, emotional, public and private behavior.
Measured: 0 weeks, 7 weeks, 14 weeks and at follow up 6 months after treatment.
Ongoing alcohol/drug cravings
VAS Single Item Craving Question (Reid, Flammino, Starosta, Palamar, \& Franck, 2006), a self-assessment VAS-scale ranging from 0 (no craving) to 100 (maximum craving).
Measured: 0 weeks, 7 weeks, 14 weeks and at follow up 6 months after treatment.
Emotion regulation
Difficulties in Emotion Regulation Scale-16 (DERS-16; Bjureberg et al., 2016), a self-assessment scale measuring problems with emotion regulation in five domains, ability to control impulses in when distressed, non-acceptance of negative emotions, goal orientation when distressed, limited access to emotion regulation strategies perceived as effective and emotional clarity. Consists of 16 items, answers on a Likert-scale ranging from 1 (almost never) to 5 (almost always).
Measured: 0 weeks, 7 weeks, 14 weeks and at follow up 6 months after treatment.
Goal directed behavior, engagement in goal behaviors and obstacles to prosocial and healthy behavioral patterns
Bull's-Eye Values Survey (BEVS; Lundgren et al., 2012). Therapist guided. The scale ranges from 0-7 and is illustrated with a physical metaphor of a dartboard.
Measured: 0 weeks, 7 weeks, 14 weeks and at follow up 6 months after treatment.
Psychological flexibility
Avoidance and Fusion Questionnaire Short Version (AFQ-Y8; Livheim et al.,2016) a self-assessment scale measuring psychological flexibility in adolescents. Consists of 8 items.
Measured: 0 weeks, 7 weeks, 14 weeks and at follow up 6 months after treatment.
Negative effects of treatment
Negative Effects Questionnaire (NEQ; Rozental, Kottorp, Boettcher, Andersson, \& Carlbring, 2016) NEQ-20 investigate participants' negative effects of psychological treatments. Total range is 0-80, with higher values representing a worse outcome.
Measured: 7 weeks, 14 weeks and at follow up 6 months after treatment.
Level of Service/Case Management Inventory
Level of Service/Case Management Inventory (LS/CMI; Andrews, Bonta, \& Wormith, 2000) is a clinician administered instrument to evaluate the risks and needs in youthful offenders and is often used to guide case management. Involves antisocial and pro-criminal attitudes.
Measured: 0 weeks, 14 weeks and at follow up 6 months after treatment.
Alcohol Use Disorders Identification Test
- Alcohol Use Disorders Identification Test (AUDIT; Saunders et al., 1993) a self-assessment scale screening for hazardous drinking and alcohol abuse disorder.
Measured: 0 weeks, 14 weeks and at follow up 6 months after treatment.
Drug Use Disorders Identification Test
- Drug Use Disorders Identification Test (DUDIT; Berman, Bergman, Palmstierna, \& Schlyter, 2005) a self-assessment scale measuring the use and disorder of drugs.
Measured: 0 weeks, 14 weeks and at follow up 6 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start16 Feb 2022
- Primary completion30 Sep 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- National Board of Institutional Care, Sweden
- Responsible party
- Principal investigator, Tobias Lundgren, Karolinska Institutet
- Investigators
- Tobias Lundgren, PhD, Principal investigator, Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05081934
- Sponsor's protocol ID
- 2021-02258
- Status last verified
- Oct 2023
- First submitted
- 14 Sep 2021
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Malarstig I, Tyrberg M, Spannargard A, Garke MA, Lundgren T, Alfonsson S. Adolescent community reinforcement approach in secure care for adolescents with substance use and serious norm-violating behaviour: a randomised feasibility trial. BMJ Open. 2026 Feb 9;16(2):e111332. doi: 10.1136/bmjopen-2025-111332.
PubMed 41663166
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability and Preliminary Treatment Effects of Adolescent Community Reinforcement Approach, A-CRA, for Youth in Compulsory Institutional Care
- ClinicalTrials.gov ID
- NCT05081934
- Acronym / sponsor ID
- 2021-02258
- Conditions
- Substance Use Disorders, Criminal Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- National Board of Institutional Care, Sweden
- Study start
- 16 Feb 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 18 Oct 2021 (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.
Substance abuse and criminal behavior are increasing among adolescents in Sweden. The Swedish National Board of Institutional Care, SiS, provides institutional care on basis of the Swedish laws Care of Young Persons (Special Provisions) Act, LVU, Care of Substance Abusers (Special Provisions) Act, LVM, Secure Youth Care Act, LSU. Treatment is provided at locked youth residential homes. The Adolescent Community Reinforcement Approach, A-CRA, an empirically supported substance use treatment, promotes long-term abstinence, increases social stability and decreases depression and other co-morbid psychiatric problems. However, A-CRA has mostly been delivered and evaluated within outpatient care. It is unclear whether A-CRA is as effective when delivered in compulsory care where many adolescents with severe substance use disorder and criminal behavior receive treatment. This study is the first part of a larger project with the overall objective to evaluate and adjust A-CRA to the compulsory care provided at National Board of Institutional Care (Statens institutionsstyrelse, SiS) for justice-involved youth. The aim of this first part is to examine feasibility, acceptability and preliminary effects of A-CRA when provided in institutional care (SiS). Furthermore, to explore experiences of undergoing and delivering A-CRA in the institutional setting. Data collected from this study will be used for improvement of a coming full scale randomized controlled trial planned for 2022. Expected results are that A-CRA is feasible in the institutional environment, that A-CRA is perceived as helpful and acceptable by therapists and adolescents, that planned procedures are feasible and data collection and recruitment works satisfactorily.
Detailed description
The primary objective of this study is to evaluate the feasibility, acceptability and preliminary effects of the empirically supported treatment A-CRA when adjusted to, and delivered in, the institutional care of SiS. Furthermore, to increase pro-social behavior/attitudes and psychological flexibility, to improve mental health and to decrease criminal behavior and substance abuse in youth suffering from substance use disorder and/or disruptive behaviors. This study consists of a qualitative and a quantitative part 1) semi-structured interviews with adolescents and therapists involved in treatment to explore experiences 2) a pilot study to evaluate acceptability, feasibility and preliminary effects of A-CRA. Treatment type and dose (number of sessions received and length of sessions) are registered to enable future analyzes. Acceptability (perceived helpfulness and comprehensibility) is measured using a 7-point Likert-scale, ranging from 1 (not at all helpful) to 7 (very helpful).
Adolescents are randomized to either standard care alone or standard care with the addition of A-CRA. Standard care is defined as the interventions and treatments adolescents are usually offered and undergo in institutional care. These are Motivational Interviewing, MI, Cognitive Behavioral Therapy, CBT, Aggression Replacement Therapy, ART or Acceptance and Commitment Therapy, ACT. This will be further specified and registered in the initial phase of the study, in collaboration with SiS. Randomization takes place at the individual level with even allocation to the groups. Quantitative measurements take place before, during and after treatment as well as follow up once a month for six months. Potential adverse events will be collected after treatment completion using open questions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual, TAU | Active comparator | Behavioral: TAUTAU: Interventions and treatments usually offered and delivered in institutional care. For example, Motivational Interviewing, MI, Cognitive Behavioral Therapy, CBT, Aggression Replacement Therapy, ART or Acceptance and Commitment Therapy, ACT. Further specification of TAU will be made in collaboration with the institutions included in the trial. |
| TAU + A-CRA | Experimental | Behavioral: A-CRA, Behavioral: TAUBehavioral: A-CRA, a 12-14 weekly sessions long behavioral treatment for youth (ages 12-25) suffering from substance use disorder and co-occurring problems, i.e. criminal behavior. The aim is to increase constructive behavior that reduces the need of substances and creates a context where it is rewarding to stay sober. Individual functional analyses, goals and needs guides treatment planning and interventions. TAU: interventions and treatments usually offered and delivered in institutional care. For example, Motivational Interviewing, MI, Cognitive Behavioral Therapy, CBT, Aggression Replacement Therapy, ART or Acceptance and Commitment Therapy, ACT. Further specification of TAU will be made in collaboration with the institutions included in the trial. |
Who may qualify
- Ages
- 16 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age 16-21, placed in institutional care (SiS), with substance use disorder and criminal, violent or destructive behavior, willing and able to undergo A-CRA during their placement.
- Ability to read and understand informed consent.
Key exclusion criteria (2 listed)
- Severe cognitive or psychiatric condition that obstructs ability to provide informed consent or to undergo assessment or interventions.
- Serious somatic condition requiring acute medical attention.
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 |
|---|---|---|
| A-CRA12-14 weekly sessions of A-CRA, a behavioral treatment for youth suffering from substance use disorder and co-occurring problems. The average time for a placement within SiS is for boys 5,9 months and for girls 4,5 months. To further adjust A-CRA to the closed institutional care, frequency of sessions may be increased to twice a week. This is to facilitate maintaining of focus in treatment and closely follow treatment progress. Treatment consists of 18 procedures that aim to reduce problematic behaviors and increase constructive behaviors. Example of procedures are functional analysis of substance use behavior, functional analysis of prosocial behavior, increasing prosocial activities, drink/drug refusal, relapse prevention, anger management and caregiver sessions. Procedures are combined and tailored to youth individual goals and needs. | Behavioural | TAU + A-CRA |
| TAUStandard care is defined as the interventions and treatments adolescents are usually offered and undergo in institutional care. These are Motivational Interviewing, MI, Cognitive Behavioral Therapy, CBT, Aggression Replacement Therapy, ART or Acceptance and Commitment Therapy, ACT. This will be further specified and registered in the initial phase of the study, in collaboration with SiS. | Behavioural | TAU + A-CRA, Treatment as usual, TAU |
Primary outcome
Attrition
Time frame: During treatment and at follow up 6 months.
Attrition defined as participants discontinuing treatment and assessments.
Inclusion rate.
Time frame: 0 weeks.
Proportion of youth accepting to participate after being informed about randomization and offered treatment.
Treatment completion.
Time frame: Immediately after completion.
Percentage of treatment completers defined as participants who underwent all planned A-CRA modules.
14 secondary outcomes
Completed treatment sessions
Time frame: Registered weekly
Length of treatment sessions
Time frame: Registered after every session
Treatment period
Time frame: 0 weeks to treatment completion.
Acceptability of treatment
Time frame: Post treatment.
Depression, anxiety and stress
Time frame: 0 weeks, 7 weeks, 14 weeks and at follow up 6 months after treatment.
Pro-social behavior
Time frame: 0 weeks, 7 weeks, 14 weeks and at follow up 6 months after treatment.
Ongoing alcohol/drug cravings
Time frame: 0 weeks, 7 weeks, 14 weeks and at follow up 6 months after treatment.
Emotion regulation
Time frame: 0 weeks, 7 weeks, 14 weeks and at follow up 6 months after treatment.
Goal directed behavior, engagement in goal behaviors and obstacles to prosocial and healthy behavioral patterns
Time frame: 0 weeks, 7 weeks, 14 weeks and at follow up 6 months after treatment.
Psychological flexibility
Time frame: 0 weeks, 7 weeks, 14 weeks and at follow up 6 months after treatment.
Negative effects of treatment
Time frame: 7 weeks, 14 weeks and at follow up 6 months after treatment.
Level of Service/Case Management Inventory
Time frame: 0 weeks, 14 weeks and at follow up 6 months after treatment.
Alcohol Use Disorders Identification Test
Time frame: 0 weeks, 14 weeks and at follow up 6 months after treatment.
Drug Use Disorders Identification Test
Time frame: 0 weeks, 14 weeks and at follow up 6 months after treatment.
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 19 Dec 2024.
- Derived from this study: PubMed 41663166Malarstig I, Tyrberg M, Spannargard A, Garke MA, Lundgren T, Alfonsson S. Adolescent community reinforcement approach in secure care for adolescents with substance use and serious norm-violating behaviour: a randomised feasibility trial. BMJ Open. 2026 Feb 9;16(2):e111332. doi: 10.1136/bmjopen-2025-111332.
- Individual participant dataSharing planned: No
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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.
Tobias Lundgren, PhD principal investigator
Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A-CRA and TAU in people with Substance Use Disorders and Criminal Behavior, run by Karolinska Institutet at 1 site in Sweden.
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 2 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 19 Dec 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 Sweden. 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?
Attrition (time frame: During treatment and at follow up 6 months.). 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?
On the ClinicalTrials.gov record for NCT05081934, 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 19 Dec 2024.