Methamphetamine Use Disorder
Conditions
Keywords
methamphetamine, methadone, Vietnam, STAR-OM
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.
Interventions
BEHAVIORALContingency management for substance use
Participants receive escalating incentives for each consecutive negative weekly urine drug screen.
BEHAVIORALContingency management for attendance
Participants receive escalating incentives for each consecutive counseling session they attended.
BEHAVIORALGroup-based Matrix counseling
Group-based Matrix counseling
BEHAVIORALIndividual-based Matrix counseling
Individual-based Matrix counseling
Sponsors
Hanoi Medical University
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rates for screening and for enrollment to measure feasiblity of recruitment | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Depression, Anxiety and Stress Scale version with 21 items (DASS-21) | 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. |
| Rapid HIV testing | From baseline to 12-week follow-up | Changes in HIV status as determined by rapid HIV testing between baseline and 12-week follow-up |
| Chesney (1997)'s questionnaire on HIV sexual risk behaviors related to substance use | 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. |
| 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 | 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). |
| 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 | 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). |
Countries
Vietnam
Contacts
PRINCIPAL_INVESTIGATORGiang M. Le, MD, PhD
Hanoi Medical University
Outcome results
None listed