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临床试验/NCT07121296
NCT07121296已完成不适用

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

Hanoi Medical University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年2月24日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Recruitment rates for screening and for enrollment to measure feasiblity of recruitment

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

Contingency management for Substance use

Experimental

Participants receive contingency management for their abstinence over 12 weeks

干预措施: Contingency management for substance use (Behavioral)

Group-based Matrix plus contingency management

Experimental

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

干预措施: Contingency management for attendance (Behavioral)

Group-based Matrix plus contingency management

Experimental

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

干预措施: Group-based Matrix counseling (Behavioral)

Individual-based Matrix plus contingency management

Experimental

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

干预措施: Contingency management for attendance (Behavioral)

Individual-based Matrix plus contingency management

Experimental

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

干预措施: Individual-based Matrix counseling (Behavioral)

结局指标

主要结局

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

时间窗: Over the 3-month recruitment period

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.

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

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

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.

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

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

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.

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

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

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.

次要结局

  • 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)
  • Themes of perceptions from focus groups and in-depth interviews regarding how acceptable it is to provide medications to treat methamphetamine use disorder(Within 2 weeks after the last participant completes the intervention)

研究者

发起方
Hanoi Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giang Le Minh

Dean of the Institute of Preventive Medicine and Public Health

Hanoi Medical University

研究点 (2)

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