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

NCT07121296 | Active Not Recruiting

• 1 other identifier: 3R01DA050486-05S1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Methamphetamine Use Disorder

Keywords

methamphetamine; methadone; Vietnam; STAR-OM

Outcome Measures

Primary Outcomes (4)

• 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.

  Over the 3-month recruitment period

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (6)

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

  From baseline to 12-week follow-up

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

  From baseline to 12-week follow-up

• Rapid HIV testing

  From baseline to 12-week follow-up

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

  From baseline to 12-week follow-up

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

  Within 2 weeks after the last participant completes the intervention

Study Arms (3)

Contingency management for Substance use

EXPERIMENTAL

Participants receive contingency management for their abstinence over 12 weeks

Behavioral: Contingency management for substance use

Group-based Matrix plus contingency management

EXPERIMENTAL

Participants receive group-based Matrix counseling and contingency management for their attendance in group counseling sessions

Behavioral: Contingency management for attendance; Behavioral: Group-based Matrix counseling

Individual-based Matrix plus contingency management

EXPERIMENTAL

Participants receive individual-based Matrix counseling and contingency management for their attendance in individual counseling sessions

Behavioral: Contingency management for attendance; Behavioral: Individual-based Matrix counseling

Interventions

Contingency management for substance use BEHAVIORAL

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

Contingency management for Substance use

Contingency management for attendance BEHAVIORAL

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

Group-based Matrix plus contingency management; Individual-based Matrix plus contingency management

Group-based Matrix counseling BEHAVIORAL

Group-based Matrix counseling

Group-based Matrix plus contingency management

Individual-based Matrix counseling BEHAVIORAL

Individual-based Matrix counseling

Individual-based Matrix plus contingency management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hanoi Medical University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Hanoi Medical University

Hanoi, Hanoi, 100000, Vietnam

Location

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Study Officials

• Giang M. Le, MD, PhD

  Hanoi Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of the Institute of Preventive Medicine and Public Health

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: August 13, 2025
• Study Start: February 24, 2025
• Primary Completion: August 29, 2025
• Study Completion: September 30, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08

Locations

VN (1)