Screen, Treat and Retain People With Primary Meth Use Dis... | NCT07121296

ID	Type	Description	Link
3R01DA050486-05S1	U.S. NIH Grant/Contract		View source

Status Module

Name	Class
National Institute on Drug Abuse (NIDA)	NIH

Description Module

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.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Contingency management for substance use	Behavioral	Participants receive escalating incentives for each consecutive negative weekly urine drug screen.	Contingency management for Substance use

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

Name	Affiliation	Role
Giang M. Le, MD, PhD	Hanoi Medical University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Hanoi Medical University		Hanoi	Hanoi	100000	Vietnam

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34793523	Background	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.
36441408	Background