Hanoi Medical University
Hanoi, 100000, Vietnam
NCT Number: NCT07121296
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Hanoi, 100000, Vietnam
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants receive escalating incentives for each consecutive negative weekly urine drug screen.
Participants receive escalating incentives for each consecutive counseling session they attended.
Group-based Matrix counseling
Individual-based Matrix counseling
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline to 12-week follow-up
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.
Time frame: From baseline to 12-week follow-up
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.
Time frame: From baseline to 12-week follow-up
Changes in HIV status as determined by rapid HIV testing between baseline and 12-week follow-up
Time frame: From baseline to 12-week follow-up
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.
Time frame: Within 2 weeks after the last participant completes the intervention
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).
Time frame: Within 2 weeks after the last participant completes the intervention
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).
Hanoi Medical University
Other
Acronym: STAR-OM+
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06538285
Behavior, Chemsex
San Francicso, California, United States
View Trial DetailsNCT06745128
Body Weight, Methamphetamine Use Disorder
Dallas, Texas, United States
View Trial DetailsNCT05558358
Methamphetamine Use Disorder
Aurora, Colorado, United States
View Trial DetailsNCT06288997
Methamphetamine Use Disorder
Beijing, Beijing Municipality, China
View Trial Details