Methamphetamine UseFB-WWUMNCT06789523

Friendship Bench for Women Who Use Methamphetamine in Vietnam

A study testing Friendship Bench and Usual psychiatric care in people with Methamphetamine Use and Common Mental Disorders (CMD), run by Hanoi Medical University at 1 site in Vietnam.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Methamphetamine Use, Common Mental Disorders (CMD)
What is being tested?: Friendship Bench and Usual psychiatric care
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteVietnam
Study dates: 11 Jun 2025to 31 Aug 2029
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
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult women (>=18 years old)
Moderate or greater risk for meth use (ASSIST ≥ 4)
Moderate or greater CMD symptom severity (Depression ≥ 10, Anxiety ≥ 8, and/or Stress ≥ 15 on DASS-21)

Who cannot join

Severe psychotic disorders or other interfering problems that require specialty care;
Inability to understand study procedures by the research team's judgment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Trang Thu Nguyen, PhD contact

+84 988 424 871

trangthu@hmu.edu.vn

Vietnam1 site, 1 recruiting

Friendship Bench & Lighthouse
Haiphong, Hai Phong, 100000
Trang Thu Nguyen, PhD, +84 988 424 871, trangthu@hmu.edu.vn
Trang Thu Nguyen, PhD
Recruiting

Other trials in Vietnam

About this study

The high comorbidity of mental health issues and meth use in women worsens both their mental health and meth use outcomes. The study team proposes to evaluate the potential of Friendship Bench to be used as a low-threshold, task-shifting mental health intervention among women who use methamphetamine in Vietnam - a lower-middle-income country. The study will provide preliminary data for a R01 trial testing the effectiveness Friendship Bench to improve mental health and methamphetamine use outcomes among women who use methamphetamine in Vietnam.

Read the detailed description

The specific aims of this research proposal are to: (1) assess the mental health needs of WWUM in Haiphong, (2) adapt Friendship Bench to the specific needs of Vietnamese WWUM and (3) assess the feasibility, fidelity, and acceptability of the adapted Friendship Bench for common mental disorders among WWUM and preliminary indicators of its impact in improving their mental health and methamphetamine use in a two-arm randomized trial, comparing Friendship Bench with usual psychiatric care.

Conditions: Methamphetamine Use, Common Mental Disorders (CMD)
Being tested: Friendship Bench, Usual psychiatric care
Keywords: methamphetamine, women who use drugs, common mental disorders, Friendship Bench, lay worker-delivered intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Friendship BenchBehavioural
The Friendship Bench model comprises 6 weekly, individual sessions with trained peer workers in addition to the usual care. Peer workers will help participants identify problems, outline potential solutions, and implement selected solutions.
The adaptation of Friendship Bench for Vietnamese methadone patients made revisions, such as removing the 'Belief in supernatural powers' section, replacing the Shona Symptom Questionnaire with DASS-21, and adding meth use. But this adaptation removed women-focused content on pregnancy and postpartum depression that we plan to include.
Usual psychiatric careBehavioural
Usual care includes monthly check-ups by peer workers, referral to hospital-based psychiatric services or other available mental health services if needed. This usual care might surpass standard psychiatric care in other provinces given that peer workers in Haiphong have been well trained on case management skills.

Study groups in NCT06789523
Study group	Role	What they receive
Friendship Bench	Experimental	Participants randomized to the intervention condition will receive the adapted Friendship Bench intervention. Receives: Behavioral: Friendship Bench
Usual psychiatric care	Active comparator	Participants in the control group will receive usual care for their common mental disorders. Receives: Behavioral: Usual psychiatric care

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility: the ability to enroll women who use meth with common mental disorders in the pilot
The ability to enroll WWUM is assessed through the recruitment rate (number of WWUM approached to accrue the final sample) and reasons for non-participation.
Measured: From enrollment to the end of intervention at 6 weeks
Feasibility: the ability to retain WWUM with common mental disorders in the pilot
Based on data from previous studies in Vietnam, the study team defines feasible retention as 80% retention at 6-weeks.
Measured: From enrollment to the end of intervention at 6 weeks
Feasibility: adequate completion of Friendship Bench sessions
As peer outreach workers will conduct home visits or visits to workplace, the study team considers 70% participants attending all 6 individual sessions to be feasible. The reasons for session non-attendance, and counselor time per session and per patient including preparation, documentation, and supervision will also be assessed to explain the Friendship Bench completion rate.
Measured: From enrollment to the end of intervention at 6 weeks
Acceptability
Acceptability is defined as the perception among implementation stakeholders that the intervention is agreeable or satisfactory. The study team will assess acceptability through the 6-week follow-up interview with all participants (n=100) and peer workers (n=10). Acceptability will also be assessed qualitatively using the post-intervention in-depth interviews with peer workers (n=10), participants (n=20) and brief exit interviews with supervisors (n=2). The interviews will assess how easy the intervention is to participate and to deliver, the perceived usefulness of the intervention and suggestions for improvement. Intervention acceptability is defined as 80% participants rating the intervention as acceptable and by a common theme of positive perceptions of Friendship Bench in qualitative data.
Measured: At Week 6
Fidelity
Fidelity is defined as delivery of the intervention as intended. Master trainers will use a checklist to assess fidelity to session content either during direct monitoring or using audio recording of 1 randomly chosen session per patient or up to 8 sessions per counselor. Covering at least 75% of checklist items during each session is considered fidelity to the intervention protocol.
Measured: From enrollment to the end of intervention at 6 weeks

Secondary outcomes (3)

Mental health: changes in CMD symptom response
The mental health outcome is defined to be common mental disorders symptom response and measured as a composite score. Common mental disorders symptom response is based on common mental disorders symptom improvement. Common mental disorders symptom improvement is defined as the percent improvement in each depression, anxiety and stress subscale of the 21-item Depression, Anxiety and Stress Scale (DASS-21) from baseline, averaged across only those subscales that were elevated at baseline. Each subscale ranges from 0 to 42, with higher scores indicating worse outcomes.
Measured: From enrollment to the end of intervention at 6 weeks
Meth use: self-reported changes in meth use behaviors
Meth use outcomes include changes in the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) score for meth and the amphetamine use behaviors scale between baseline and follow-up visits. The ASSIST score ranges from 0 to 39 for each drug assessed, higher scores indicating greater risk.
Measured: From enrollment to the end of intervention at 6 weeks
Meth use: changes in urinalysis
Changes in the number of participants with positive urinalysis between baseline and follow-up visits.
Measured: From enrollment to the end of intervention at 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jun 202531 Aug 2029

First posted23 Jan 2025
Study start11 Jun 2025
Primary completion31 Dec 2028 (estimated)
Study completion31 Aug 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Methamphetamine UseStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06789523
Sponsor's protocol ID: K43TW012620-01A1
Other IDs: K43TW012620-01A1
Acronym: FB-WWUM
Status last verified: Sep 2026
First submitted: 12 Dec 2024
Last updated: 16 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Tran HV, Nong HTT, Tran TTT, Filipowicz TR, Landrum KR, Pence BW, Le GM, Nguyen MX, Chibanda D, Verhey R, Go VF, Ho HT, Gaynes BN. Adaptation of a Problem-solving Program (Friendship Bench) to Treat Common Mental Disorders Among People Living With HIV and AIDS and on Methadone Maintenance Treatment in Vietnam: Formative Study. JMIR Form Res. 2022 Jul 8;6(7):e37211. doi: 10.2196/37211.
PubMed 35802402
Chibanda D, Weiss HA, Verhey R, Simms V, Munjoma R, Rusakaniko S, Chingono A, Munetsi E, Bere T, Manda E, Abas M, Araya R. Effect of a Primary Care-Based Psychological Intervention on Symptoms of Common Mental Disorders in Zimbabwe: A Randomized Clinical Trial. JAMA. 2016 Dec 27;316(24):2618-2626. doi: 10.1001/jama.2016.19102.
PubMed 28027368
Chibanda D. Reducing the treatment gap for mental, neurological and substance use disorders in Africa: lessons from the Friendship Bench in Zimbabwe. Epidemiol Psychiatr Sci. 2017 Aug;26(4):342-347. doi: 10.1017/S2045796016001128. Epub 2017 Apr 12.
PubMed 28399952
Chibanda D, Mesu P, Kajawu L, Cowan F, Araya R, Abas MA. Problem-solving therapy for depression and common mental disorders in Zimbabwe: piloting a task-shifting primary mental health care intervention in a population with a high prevalence of people living with HIV. BMC Public Health. 2011 Oct 26;11:828. doi: 10.1186/1471-2458-11-828.
PubMed 22029430
Giang HT, Duc NQ, Khue PM, Quillet C, Oanh KTH, Thanh NTT, Vallo R, Feelemyer J, Vinh VH, Rapoud D, Michel L, Laureillard D, Moles JP, Jarlais DD, Nagot N, Huong DT. Gender Differences in HIV, HCV risk and Prevention Needs Among People who Inject drug in Vietnam. AIDS Behav. 2023 Jun;27(6):1989-1997. doi: 10.1007/s10461-022-03932-x. Epub 2022 Nov 28.
PubMed 36441408
Michel L, Des Jarlais DC, Duong Thi H, Khuat Thi Hai O, Pham Minh K, Peries M, Vallo R, Nham Thi Tuyet T, Hoang Thi G, Le Sao M, Feelemyer J, Vu Hai V, Moles JP, Laureillard D, Nagot N; DRIVE Study Team. Intravenous heroin use in Haiphong, Vietnam: Need for comprehensive care including methamphetamine use-related interventions. Drug Alcohol Depend. 2017 Oct 1;179:198-204. doi: 10.1016/j.drugalcdep.2017.07.004. Epub 2017 Aug 2.
PubMed 28800503
Kittirattanapaiboon P, Srikosai S, Wittayanookulluk A. Methamphetamine use and dependence in vulnerable female populations. Curr Opin Psychiatry. 2017 Jul;30(4):247-252. doi: 10.1097/YCO.0000000000000335.
PubMed 28426546
Tracy D, Hahn JA, Fuller Lewis C, Evans J, Briceno A, Morris MD, Lum PJ, Page K. Higher risk of incident hepatitis C virus among young women who inject drugs compared with young men in association with sexual relationships: a prospective analysis from the UFO Study cohort. BMJ Open. 2014 May 29;4(5):e004988. doi: 10.1136/bmjopen-2014-004988.
PubMed 24875490
Des Jarlais DC, Feelemyer JP, Modi SN, Arasteh K, Hagan H. Are females who inject drugs at higher risk for HIV infection than males who inject drugs: an international systematic review of high seroprevalence areas. Drug Alcohol Depend. 2012 Jul 1;124(1-2):95-107. doi: 10.1016/j.drugalcdep.2011.12.020. Epub 2012 Jan 17.
PubMed 22257753
Azim T, Bontell I, Strathdee SA. Women, drugs and HIV. Int J Drug Policy. 2015 Feb;26 Suppl 1(0 1):S16-21. doi: 10.1016/j.drugpo.2014.09.003. Epub 2014 Sep 17.
PubMed 25277726

Interested in taking part?

Trang Thu Nguyen, PhD

+84 988 424 871

trangthu@hmu.edu.vn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Friendship Bench for Women Who Use Methamphetamine in Vietnam
ClinicalTrials.gov ID: NCT06789523
Acronym / sponsor ID: FB-WWUM / K43TW012620-01A1
Conditions: Methamphetamine Use, Common Mental Disorders (CMD)
Keywords: methamphetamine, women who use drugs, common mental disorders, Friendship Bench, lay worker-delivered intervention
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 100 participants (estimated)
Lead sponsor: Hanoi Medical UniversityUniversity, hospital or other
Collaborators: Fogarty International Center of the National Institute of Health, University of North Carolina, Chapel Hill, National Institute on Drug Abuse (NIDA)
Study start: 11 Jun 2025 (actual)
Primary completion: 31 Dec 2028 (estimated)
Study completion: 31 Aug 2029 (estimated)
First posted: 23 Jan 2025 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Friendship Bench	Experimental	Behavioral: Friendship BenchParticipants randomized to the intervention condition will receive the adapted Friendship Bench intervention.
Usual psychiatric care	Active comparator	Behavioral: Usual psychiatric careParticipants in the control group will receive usual care for their common mental disorders.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Adult women (>=18 years old)
Moderate or greater risk for meth use (ASSIST ≥ 4)
Moderate or greater CMD symptom severity (Depression ≥ 10, Anxiety ≥ 8, and/or Stress ≥ 15 on DASS-21)

Key exclusion criteria (2 listed)

Severe psychotic disorders or other interfering problems that require specialty care;
Inability to understand study procedures by the research team's judgment.

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
Friendship BenchThe Friendship Bench model comprises 6 weekly, individual sessions with trained peer workers in addition to the usual care. Peer workers will help participants identify problems, outline potential solutions, and implement selected solutions. The adaptation of Friendship Bench for Vietnamese methadone patients made revisions, such as removing the 'Belief in supernatural powers' section, replacing the Shona Symptom Questionnaire with DASS-21, and adding meth use. But this adaptation removed women-focused content on pregnancy and postpartum depression that we plan to include.	Behavioural	Friendship Bench
Usual psychiatric careUsual care includes monthly check-ups by peer workers, referral to hospital-based psychiatric services or other available mental health services if needed. This usual care might surpass standard psychiatric care in other provinces given that peer workers in Haiphong have been well trained on case management skills.	Behavioural	Usual psychiatric care

Primary outcome

Feasibility: the ability to enroll women who use meth with common mental disorders in the pilot
Time frame: From enrollment to the end of intervention at 6 weeks
The ability to enroll WWUM is assessed through the recruitment rate (number of WWUM approached to accrue the final sample) and reasons for non-participation.
Feasibility: the ability to retain WWUM with common mental disorders in the pilot
Time frame: From enrollment to the end of intervention at 6 weeks
Based on data from previous studies in Vietnam, the study team defines feasible retention as 80% retention at 6-weeks.
Feasibility: adequate completion of Friendship Bench sessions
Time frame: From enrollment to the end of intervention at 6 weeks
As peer outreach workers will conduct home visits or visits to workplace, the study team considers 70% participants attending all 6 individual sessions to be feasible. The reasons for session non-attendance, and counselor time per session and per patient including preparation, documentation, and supervision will also be assessed to explain the Friendship Bench completion rate.
Acceptability
Time frame: At Week 6
Acceptability is defined as the perception among implementation stakeholders that the intervention is agreeable or satisfactory. The study team will assess acceptability through the 6-week follow-up interview with all participants (n=100) and peer workers (n=10). Acceptability will also be assessed qualitatively using the post-intervention in-depth interviews with peer workers (n=10), participants (n=20) and brief exit interviews with supervisors (n=2). The interviews will assess how easy the intervention is to participate and to deliver, the perceived usefulness of the intervention and suggestions for improvement. Intervention acceptability is defined as 80% participants rating the intervention as acceptable and by a common theme of positive perceptions of Friendship Bench in qualitative data.
Fidelity
Time frame: From enrollment to the end of intervention at 6 weeks
Fidelity is defined as delivery of the intervention as intended. Master trainers will use a checklist to assess fidelity to session content either during direct monitoring or using audio recording of 1 randomly chosen session per patient or up to 8 sessions per counselor. Covering at least 75% of checklist items during each session is considered fidelity to the intervention protocol.

3 secondary outcomes

Mental health: changes in CMD symptom response
Time frame: From enrollment to the end of intervention at 6 weeks
Meth use: self-reported changes in meth use behaviors
Time frame: From enrollment to the end of intervention at 6 weeks
Meth use: changes in urinalysis
Time frame: From enrollment to the end of intervention at 6 weeks

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 16 Sep 2026.
Background: PubMed 35802402Tran HV, Nong HTT, Tran TTT, Filipowicz TR, Landrum KR, Pence BW, Le GM, Nguyen MX, Chibanda D, Verhey R, Go VF, Ho HT, Gaynes BN. Adaptation of a Problem-solving Program (Friendship Bench) to Treat Common Mental Disorders Among People Living With HIV and AIDS and on Methadone Maintenance Treatment in Vietnam: Formative Study. JMIR Form Res. 2022 Jul 8;6(7):e37211. doi: 10.2196/37211.
Background: PubMed 28027368Chibanda D, Weiss HA, Verhey R, Simms V, Munjoma R, Rusakaniko S, Chingono A, Munetsi E, Bere T, Manda E, Abas M, Araya R. Effect of a Primary Care-Based Psychological Intervention on Symptoms of Common Mental Disorders in Zimbabwe: A Randomized Clinical Trial. JAMA. 2016 Dec 27;316(24):2618-2626. doi: 10.1001/jama.2016.19102.
Background: PubMed 28399952Chibanda D. Reducing the treatment gap for mental, neurological and substance use disorders in Africa: lessons from the Friendship Bench in Zimbabwe. Epidemiol Psychiatr Sci. 2017 Aug;26(4):342-347. doi: 10.1017/S2045796016001128. Epub 2017 Apr 12.
Background: PubMed 22029430Chibanda D, Mesu P, Kajawu L, Cowan F, Araya R, Abas MA. Problem-solving therapy for depression and common mental disorders in Zimbabwe: piloting a task-shifting primary mental health care intervention in a population with a high prevalence of people living with HIV. BMC Public Health. 2011 Oct 26;11:828. doi: 10.1186/1471-2458-11-828.
Background: PubMed 36441408Giang HT, Duc NQ, Khue PM, Quillet C, Oanh KTH, Thanh NTT, Vallo R, Feelemyer J, Vinh VH, Rapoud D, Michel L, Laureillard D, Moles JP, Jarlais DD, Nagot N, Huong DT. Gender Differences in HIV, HCV risk and Prevention Needs Among People who Inject drug in Vietnam. AIDS Behav. 2023 Jun;27(6):1989-1997. doi: 10.1007/s10461-022-03932-x. Epub 2022 Nov 28.
Background: PubMed 28800503Michel L, Des Jarlais DC, Duong Thi H, Khuat Thi Hai O, Pham Minh K, Peries M, Vallo R, Nham Thi Tuyet T, Hoang Thi G, Le Sao M, Feelemyer J, Vu Hai V, Moles JP, Laureillard D, Nagot N; DRIVE Study Team. Intravenous heroin use in Haiphong, Vietnam: Need for comprehensive care including methamphetamine use-related interventions. Drug Alcohol Depend. 2017 Oct 1;179:198-204. doi: 10.1016/j.drugalcdep.2017.07.004. Epub 2017 Aug 2.
Background: PubMed 28426546Kittirattanapaiboon P, Srikosai S, Wittayanookulluk A. Methamphetamine use and dependence in vulnerable female populations. Curr Opin Psychiatry. 2017 Jul;30(4):247-252. doi: 10.1097/YCO.0000000000000335.
Background: PubMed 24875490Tracy D, Hahn JA, Fuller Lewis C, Evans J, Briceno A, Morris MD, Lum PJ, Page K. Higher risk of incident hepatitis C virus among young women who inject drugs compared with young men in association with sexual relationships: a prospective analysis from the UFO Study cohort. BMJ Open. 2014 May 29;4(5):e004988. doi: 10.1136/bmjopen-2014-004988.
Background: PubMed 22257753Des Jarlais DC, Feelemyer JP, Modi SN, Arasteh K, Hagan H. Are females who inject drugs at higher risk for HIV infection than males who inject drugs: an international systematic review of high seroprevalence areas. Drug Alcohol Depend. 2012 Jul 1;124(1-2):95-107. doi: 10.1016/j.drugalcdep.2011.12.020. Epub 2012 Jan 17.
Background: PubMed 25277726Azim T, Bontell I, Strathdee SA. Women, drugs and HIV. Int J Drug Policy. 2015 Feb;26 Suppl 1(0 1):S16-21. doi: 10.1016/j.drugpo.2014.09.003. Epub 2014 Sep 17.
Individual participant dataSharing planned: Undecided

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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.

Trang Thu Nguyen, PhD contact

+84 988 424 871

trangthu@hmu.edu.vn

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Friendship Bench and Usual psychiatric care in people with Methamphetamine Use and Common Mental Disorders (CMD), run by Hanoi Medical University at 1 site in Vietnam.

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 3 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: looking for participants now, as of the sponsor's last update on 16 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 1 site in Vietnam. 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 Trang Thu Nguyen, PhD (+84 988 424 871, trangthu@hmu.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility: the ability to enroll women who use meth with common mental disorders in the pilot (time frame: From enrollment to the end of intervention at 6 weeks). The study lists 5 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 NCT06789523, which also lists 10 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 16 Sep 2026.