AzTrials
AzTrials

Methamphetamine Use DisorderSTAR-OM+NCT07121296

Screen, Treat and Retain People With Primary Meth Use Disorder at MMT Clinics

A study testing Contingency management for substance use, Contingency management for attendance and Group-based Matrix counseling in people with Methamphetamine Use Disorder, run by Hanoi Medical University at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is built upon the STAR-OM study (R01 DA050486) to assess if providing psycho-behavioral interventions and medications for people with primary methamphetamine use disorder (MUD) and without opioid use disorder (OUD) at methadone clinics is feasible and acceptable. In Vietnam and many U.S. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Methamphetamine Use Disorder
What is being tested?
Contingency management for substance use, Contingency management for attendance and Group-based Matrix counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteVietnam
Study dates
24 Feb 2025to 30 Sep 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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: ≥ 18
  • ASSIST ≥ 10 OR urine drug screen positive with meth
  • Urine drug screen negative with opioid and methadone
  • Willing to participate in study interventions at selected MMT clinics

Who cannot join

  • Unable to read and write Vietnamese
  • Being incapable of understanding questions and research processes

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

  • Hanoi Medical University

    Hanoi, Hanoi, 100000

Other trials in Vietnam

About this study

This study is built upon the STAR-OM study (R01 DA050486) to assess if providing psycho-behavioral interventions and medications for people with primary methamphetamine use disorder (MUD) and without opioid use disorder (OUD) at methadone clinics is feasible and acceptable. In Vietnam and many U.S. settings, clinics providing medication for OUD (especially methadone clinics) are the only viable option for evidence-based addiction treatment. Importantly, many of these clinics are at primary care level and therefore accessible to people with primary MUD, who are in dire need for effective treatment. Furthermore, providers in methadone clinics are capable of conducting psycho-behavioral interventions, which remain the first line of treatment for MUD, and prescribing medications should these medications become available and approved by authorities. It remains unknown, however, if methadone clinics could serve as treatment facilities for those with primary MUD. This Supplement to the STAR-OM study will 1) assess the feasibility and acceptability of three recruitment strategies to enroll people with MUD and without OUD in MUD treatment at methadone clinics and 2) explore the feasibility and acceptability of providing psycho-behavioral interventions as well as challenges in providing medications at methadone clinics for people with MUD and without OUD. In Aim 1, the study will screen 600 people with primary MUD recruited through three strategies (peer outreach, snowballing and social media) over 3 months to enroll 60 people with MUD and without OUD into the study interventions. Participants will be screened at MMT clinics for meth use and readiness for MUD intervention. The study team will monitor recruitment rate for each strategy to assess feasibility. Acceptability will be assessed through focus group discussions with people who support recruitment (N=2 focus group with 12-16 participants), in-depth interviews with individuals eligible for enrollment and agree or decline to participate in the study interventions (N=15, 5 per recruitment strategy). In Aim 2, consenting participants will be randomized 1:1:1 into three arms of interventions over 12 weeks: (1) contingency management only; (2) group-based Matrix plus contingency management; and (3) individual-based Matrix plus contingency management. All participants will be required to provide urine samples randomly once a week. The investigators will monitor participation and retention rate in each treatment arm and completion of urine drug screens to assess feasibility. Acceptability will be assessed through post-intervention in-depth interviews with 15 participants, focus groups with methadone providers who deliver behavioral interventions (N = 1 focus group with 6-8 participants), and in-depth interviews with policy makers at national and city levels (N=5). In addition, participants will be asked in these interviews and focus groups about the challenges and facilitators of providing medications for treatment of MUD at MMT clinics should they become available. Findings from this Supplement will be used to prepare for a larger trial to assess effectiveness of implementing psycho-behavioral interventions for people with primary MUD and without OUD at methadone clinics.

Being tested
Contingency management for substance use, Contingency management for attendance, Group-based Matrix counseling, Individual-based Matrix counseling
Keywords
methamphetamine, methadone, Vietnam, STAR-OM

What participants receive

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

  • Contingency management for substance useBehavioural

    Participants receive escalating incentives for each consecutive negative weekly urine drug screen.

  • Contingency management for attendanceBehavioural

    Participants receive escalating incentives for each consecutive counseling session they attended.

  • Group-based Matrix counselingBehavioural

    Group-based Matrix counseling

  • Individual-based Matrix counselingBehavioural

    Individual-based Matrix counseling

Study groups in NCT07121296
Study groupRoleWhat they receive
Contingency management for Substance useExperimentalParticipants receive contingency management for their abstinence over 12 weeks
Receives: Behavioral: Contingency management for substance use
Group-based Matrix plus contingency managementExperimentalParticipants receive group-based Matrix counseling and contingency management for their attendance in group counseling sessions
Receives: Behavioral: Contingency management for attendance; Behavioral: Group-based Matrix counseling
Individual-based Matrix plus contingency managementExperimentalParticipants receive individual-based Matrix counseling and contingency management for their attendance in individual counseling sessions
Receives: Behavioral: Contingency management for attendance; Behavioral: Individual-based Matrix counseling

What is being measured

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

  1. Recruitment rates for screening and for enrollment to measure feasiblity of recruitment

    Feasibility will be evaluated 1) by recruitment rate for screening at selected methadone clinics and 2) by recruitment rate for the study interventions among those screened. Feasibility is defined as at least 50% of those approached agree to participate in screening and among those eligible at least 50% agree to participate in the study interventions.

    Measured: Over the 3-month recruitment period

  2. Themes of perceptions regarding each recruitment strategy from focus groups and in-depth interviews to assess the acceptability of recruitment strategies

    Acceptability will be assessed by perceived challenges and facilitators of recruitment and enrollment. Two focus group discussions will be organized with 12-16 participants who support recruitment and 15 in-depth interviews (5 per recruitment strategy) will be conducted with individuals eligible for enrollment and agree or decline to participate in the study interventions. Themes of positive perceptions of recruitment and enrollment are considered indicators of acceptability.

    Measured: Two weeks at the end of the 3-month recruitment period

  3. Rate of attendance in intervention sessions, rate of retention and rate of completion of urine drug screen to measure the feasibility of providing interventions at methadone clinics

    Feasibility is defined by the rate of attendance in intervention sessions, retention in treatment and completion of urine drug screens (UDS). The STAR-OM data indicated that in any given week, approximately 85% of participants attended Matrix sessions and 88% completed UDS visits. Acknowledging the challenges facing people with primary MUD and without OUD in attending intervention sessions at methadone clinics regularly over 12 weeks, the study intervention is deemed feasible if the study reaches 70% of overall intervention attendance and 70% of overall UDS completion.

    Measured: Up to 12 weeks per participants from enrollment to completion of intervention

  4. Themes of perceptions from focus groups and in-depth interviews regarding how acceptable it is to provide intervention at methadone clinics and percentage of participants indicating that the intervention is satisfactory

    Acceptability is defined as a common theme of positive perceptions among both participants and providers of providing each type of intervention, behavioral or medication, for people with primary MUD but without OUD at methadone clinics. Acceptability will be assessed through post-intervention in-depth interviews with 15 participants, focus groups with methadone providers who deliver behavioral interventions (N = 1 focus group with 6-8 participants), and in-depth interviews with policy makers at national and city levels (N=5). Acceptability is also defined by 70% of participants indicating that the intervention is agreeable or satisfactory in the 12-week assessment.

    Measured: Upon the completion of intervention (Week 12) per selected participants

Secondary outcomes (6)

  1. Number of meth use days, cost for meth use in the past 30 days and urine test results over 12 weeks of intervention

    Changes in reported meth use and urine drug screen results between baseline and 12-week follow-up. The study team uses Timeline Follow-back method to collect data on the number of meth use days and the cost for meth use in the past 30 days at baseline and at 12-week follow-up visit. Participants undergo one weekly urine drug screen throughout the 12 weeks of intervention.

    Measured: From baseline to 12-week follow-up

  2. Depression, Anxiety and Stress Scale version with 21 items (DASS-21)

    Changes in the mean scores of each of the subscales in the Depression, Anxiety and Stress Scale version with 21 items (DASS-21) between baseline and 12-month follow-up. DASS-21 has 3 subscales for depression, anxiety and stress. Each subscale has 7 items, rated on a 4-point Likert scale. Scores (after multiplying by 2) range from 0 to 42. Lower scores mean better mental health status.

    Measured: From baseline to 12-week follow-up

  3. Rapid HIV testing

    Changes in HIV status as determined by rapid HIV testing between baseline and 12-week follow-up

    Measured: From baseline to 12-week follow-up

  4. Chesney (1997)'s questionnaire on HIV sexual risk behaviors related to substance use

    HIV sexual risk behaviors related to substance use are measured using Chesney et al. (1997)'s questionnaire. Injection practices in relation to meth use are also inquired. This section consists of 8 questions asking about unprotected sexual behaviors and injection equipment sharing. The unit of measure is percentage of participants indicating yes for each risk behavior.

    Measured: From baseline to 12-week follow-up

  5. Themes of perceptions from focus groups and in-depth interviews regarding how feasible it is to provide medications to treat methamphetamine use disorder

    Feasibility of providing medications at methadone clinics for people with primary methamphetamine use disorder and without opioid use disorder is assessed qualitatively and defined as a common theme of positive perceptions among MMT providers and policy makers (1 focus group with 6-8 MMT providers, and 5 in-depth interviews with policy makers at national and city levels).

    Measured: Within 2 weeks after the last participant completes the intervention

  6. Themes of perceptions from focus groups and in-depth interviews regarding how acceptable it is to provide medications to treat methamphetamine use disorder

    Acceptability of providing medications at methadone clinics for people with primary methamphetamine use disorder and without opioid use disorder is assessed qualitatively and defined as a common theme of positive perceptions among MMT providers and policy makers (1 focus group with 6-8 MMT providers, and 5 in-depth interviews with policy makers at national and city levels).

    Measured: Within 2 weeks after the last participant completes the intervention

Timeline

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

  1. First posted13 Aug 2025
  2. Study start24 Feb 2025
  3. Primary completion29 Aug 2025
  4. Study completion30 Sep 2025

Resources

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
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07121296
Sponsor's protocol ID
3R01DA050486-05S1
Other IDs
3R01DA050486-05S1
Acronym
STAR-OM+
Status last verified
Sep 2026
First submitted
22 Jul 2025
Last updated
16 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Des Jarlais DC, Arasteh K, Huong DT, Oanh KTH, Feelemyer JP, Khue PM, Giang HT, Thanh NTT, Vinh VH, Le SM, Vallo R, Quillet C, Rapoud D, Michel L, Laureillard D, Moles JP, Nagot N; DRIVE Study Team. Using large-scale respondent driven sampling to monitor the end of an HIV epidemic among persons who inject drugs in Hai Phong, Viet Nam. PLoS One. 2021 Nov 18;16(11):e0259983. doi: 10.1371/journal.pone.0259983. eCollection 2021.

    PubMed 34793523

  • 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

  • Bolivar HA, Klemperer EM, Coleman SRM, DeSarno M, Skelly JM, Higgins ST. Contingency Management for Patients Receiving Medication for Opioid Use Disorder: A Systematic Review and Meta-analysis. JAMA Psychiatry. 2021 Oct 1;78(10):1092-1102. doi: 10.1001/jamapsychiatry.2021.1969.

    PubMed 34347030

  • Weinstock J, Alessi SM, Petry NM. Regardless of psychiatric severity the addition of contingency management to standard treatment improves retention and drug use outcomes. Drug Alcohol Depend. 2007 Mar 16;87(2-3):288-96. doi: 10.1016/j.drugalcdep.2006.08.027. Epub 2006 Sep 26.

    PubMed 17005329

  • Miguel AQ, Madruga CS, Cogo-Moreira H, Yamauchi R, Simoes V, da Silva CJ, McPherson S, Roll JM, Laranjeira RR. Contingency management is effective in promoting abstinence and retention in treatment among crack cocaine users in Brazil: A randomized controlled trial. Psychol Addict Behav. 2016 Aug;30(5):536-543. doi: 10.1037/adb0000192. Epub 2016 Jul 21.

    PubMed 27442691

  • Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.

    PubMed 10245370

  • Chesney MA, Chambers DB, Kahn JO. Risk behavior for HIV infection in participants in preventive HIV vaccine trials: a cautionary note. J Acquir Immune Defic Syndr Hum Retrovirol. 1997 Dec 1;16(4):266-71. doi: 10.1097/00042560-199712010-00007.

    PubMed 9402073

  • Twitchell GR, Huber A, Reback CJ, Shoptaw S. Comparison of General and Detailed HIV Risk Assessments Among Methamphetamine Abusers. AIDS Behav. 2002;6(2):153-162. doi:10.1023/A:1015449231848

  • Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

    PubMed 2748771

  • Le MTH, Tran TD, Holton S, Nguyen HT, Wolfe R, Fisher J. Reliability, convergent validity and factor structure of the DASS-21 in a sample of Vietnamese adolescents. PLoS One. 2017 Jul 19;12(7):e0180557. doi: 10.1371/journal.pone.0180557. eCollection 2017.

    PubMed 28723909

  • McGregor C, Srisurapanont M, Mitchell A, Longo MC, Cahill S, White JM. Psychometric evaluation of the Amphetamine Cessation Symptom Assessment. J Subst Abuse Treat. 2008 Jun;34(4):443-9. doi: 10.1016/j.jsat.2007.05.007. Epub 2007 Jul 13.

    PubMed 17629443

  • Sobell LC, Sobell MB. Timeline follow-back: A technique for assessing self-reported alcohol consumption. In: Measuring Alcohol Consumption: Psychosocial and Biochemical Methods. Totowa, NJ, US: Humana Press/Springer Nature; 1992:41-72. doi:10.1007/978-1-4612-0357-5_3

  • Giang LM, Li MJ, Okafor CN, Diep NB, Shoptaw SJ. Correlates of methamphetamine use severity among patients receiving methadone maintenance treatment for opioid use disorder in Vietnam. J Subst Abuse Treat. 2022 Jan;132:108461. doi: 10.1016/j.jsat.2021.108461. Epub 2021 May 7.

    PubMed 34098204

  • Hoang TA. Civil society organisations' roles in health development in Vietnam: HIV as a case study. Glob Public Health. 2013;8 Suppl 1:S92-103. doi: 10.1080/17441692.2013.811530. Epub 2013 Jul 4.

    PubMed 23822631

  • Nguyen Bich D, Korthuis PT, Nguyen Thu T, Van Dinh H, Le Minh G. HIV Patients' Preference for Integrated Models of Addiction and HIV Treatment in Vietnam. J Subst Abuse Treat. 2016 Oct;69:57-63. doi: 10.1016/j.jsat.2016.07.003. Epub 2016 Jul 19.

    PubMed 27568511

Questions about this trial

What is this clinical trial studying?

A study testing Contingency management for substance use, Contingency management for attendance and Group-based Matrix counseling in people with Methamphetamine Use Disorder, 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 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, 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?

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?

Recruitment rates for screening and for enrollment to measure feasiblity of recruitment (time frame: Over the 3-month recruitment period). The study lists 4 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 NCT07121296, which also lists 30 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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in