Screen, Treat and Retain People With Primary Meth Use Disorder at MMT Clinics (STAR-OM+)

Hanoi Medical University

Status: Active, not recruiting

Conditions: Methamphetamine Use Disorder

Treatments: Behavioral: Contingency management for attendance; Behavioral: Contingency management for substance use; Behavioral: Group-based Matrix counseling; Behavioral: Individual-based Matrix counseling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07121296

3R01DA050486-05S1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Contingency management for Substance use

Experimental group

Description:

Participants receive contingency management for their abstinence over 12 weeks

Treatment:

Behavioral: Contingency management for substance use

Group-based Matrix plus contingency management

Experimental group

Description:

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

Treatment:

Behavioral: Group-based Matrix counseling

Behavioral: Contingency management for attendance

Individual-based Matrix plus contingency management

Experimental group

Description:

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

Treatment:

Behavioral: Individual-based Matrix counseling

Behavioral: Contingency management for attendance