MPACT Program for Opioid Use Disorder

(MPACT Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Must be taking: Methadone

Disqualifiers: Patients receiving methadone

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1080 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the MPACT treatment for opioid use disorder?

The research on methadone medical maintenance (MMM) shows that it is an effective treatment for opioid use disorder, helping patients participate in community activities and receive adequate counseling. This suggests that similar treatments like MPACT could also be effective in supporting patients with opioid use disorder. ^{1 2 3 4 5}

Is the MPACT Program for Opioid Use Disorder safe for humans?

The safety of treatments for opioid use disorder, like those in the MPACT Program, has been studied, but there are some concerns. For example, people on methadone, a common treatment, may have a higher risk of car accidents. However, the overall safety data is mixed, and more rigorous studies are needed to draw strong conclusions. ^{6 7 8 9 10}

How is the MPACT treatment for opioid use disorder different from other treatments?

The MPACT treatment is unique because it focuses on implementing medication-assisted treatment (MAT) in prisons and jails, which is uncommon despite the high prevalence of opioid use disorder among incarcerated individuals. This approach aims to expand screening, treatment, and provide linkage to community-based care upon release, addressing a critical gap in the current treatment landscape. ^{4 11 12 13 14}

What is the purpose of this trial?

The trial of Methadone Patient Access to Collaborative Treatment (MPACT) will establish the impact of the intervention on patient outcomes of methadone treatment retention and in treatment overdose. It will also establish the impact of patient and staff trauma symptoms and clinic practice change on MPACT intervention implementation.

Eligibility Criteria

This trial is for staff members who provide methadone treatment services at opioid treatment programs. It's not open to patients currently receiving methadone treatment at these facilities.

Inclusion Criteria

I work at a clinic that provides methadone for opioid treatment.

Exclusion Criteria

I am currently receiving methadone treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Implementation

MPACT intervention components are implemented, including training, self-assessment, and wellness education

15 months

Periodic surveys and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• MPACT

Trial Overview The MPACT intervention is being tested to see if it helps with keeping patients on methadone treatment and reduces overdoses while in treatment. The study will also look into how trauma symptoms affect the implementation of this program.

Participant Groups

Group I: MPACT Intervention Experimental Treatment 1 Intervention

Enrolled clinic staff will be exposed to the MPACT intervention components over the trial period. This includes accredited training, clinic self assessment, reflective supervision for counseling/peer/case management staff, and wellness education with navigation to trauma symptoms assessment and resources including trauma treatment. Periodic surveys of staff and patients will be conducted to assess outcome measures (primary and secondary) and patient chart reviews will verify patient outcomes.

Group II: Control for MPACT Active Control 1 Intervention

Enrolled clinic staff will not receive any portion of the intervention. Periodic surveys of staff and patients will be conducted to assess outcome measures (primary and secondary) and patient chart reviews will verify patient outcomes.

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Findings from Research

A study involving 96 community-based treatment staff across five methadone maintenance clinics showed that a seven-session seminar on methadone medical maintenance (MMM) significantly improved staff perceptions of its benefits, including facilitating patient participation in rehabilitation activities and ensuring adequate counseling services for MMM patients.

After the seminar, one clinic adopted an adaptive stepped care model, and three out of five clinics began implementing MMM, indicating that educational interventions can effectively promote the adoption of evidence-based practices in opioid treatment programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing methadone medical maintenance in community-based clinics: disseminating evidence-based treatment. King, VL., Burke, C., Stoller, KB., et al.[2013]

The Patient Decision Aid for Medication Treatment for Opioid Use Disorder (PtDA-MOUD) was developed with input from experts and patients, and it effectively provided information to help patients make informed treatment decisions during their initial clinical visit.

In a pilot test with 36 patients, those who used the PtDA-MOUD were more likely to start medication treatment for opioid use disorder (37% vs. 11% in controls) and received treatment for more days on average, suggesting that the decision aid may enhance treatment initiation and engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient decision aid for medication treatment for opioid use disorder (PtDA-MOUD): Rationale, methodology, and preliminary results. Mooney, LJ., Valdez, J., Cousins, SJ., et al.[2021]

Medication-Assisted Treatment (MAT) for opioid use disorder shows mixed effects on functional outcomes, with some studies indicating poorer cognitive performance, such as working memory and cognitive speed, compared to healthy controls.

While MAT users may experience lower fatigue rates with buprenorphine compared to methadone, the overall quality of evidence regarding functional outcomes is low, highlighting the need for more rigorous studies to draw stronger conclusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of medication assisted treatment (MAT) for opioid use disorder on functional outcomes: A systematic review. Maglione, MA., Raaen, L., Chen, C., et al.[2019]

Project RAMP successfully recruited 26 primary care practices across 13 counties in Pennsylvania to provide medications for opioid use disorder (MOUD), exceeding their target and demonstrating effective strategies for engaging rural healthcare providers.

Key recruitment strategies included leveraging health system leadership support and addressing barriers faced by providers, such as lack of training, which facilitated better communication and integration of care for patients with opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies to recruit rural primary care providers to implement a medication for opioid use disorder (MOUD) focused integrated care model. Cloutier, RM., Cole, ES., McDonough, BL., et al.[2023]

The Drug Abuse Treatment Act of 2000 (DATA) expanded treatment options for opioid addiction by allowing certified physicians to prescribe buprenorphine in office settings, increasing access to care.

Clinical studies show that buprenorphine is as effective as methadone for maintaining treatment and reducing illicit opioid use, and it is more effective than clonidine for short-term detoxification, highlighting its role as a valuable tool in addiction treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bupreorphine:a new pharmacotherapy for opioid addictions treatment. Stock, C., Shum, JH.[2013]

References

1. United States pubmed.ncbi.nlm.nih.gov

Implementing methadone medical maintenance in community-based clinics: disseminating evidence-based treatment. [2013]

2. England pubmed.ncbi.nlm.nih.gov

Outcomes from the medication assisted treatment pilot program for adults with opioid use disorders in rural Colorado. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Patient decision aid for medication treatment for opioid use disorder (PtDA-MOUD): Rationale, methodology, and preliminary results. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Advancing the implementation and sustainment of medication assisted treatment for opioid use disorders in prisons and jails. [2021]

5. Brazil pubmed.ncbi.nlm.nih.gov

The future of precision medicine in opioid use disorder: inclusion of patient-important outcomes in clinical trials. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Impact of a Multidisciplinary Long-Term Opioid Therapy Safety Program at a Military Tertiary Academic Medical Center. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Assessment of outcomes following high-dose opioid tapering in a Veterans Healthcare System. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of medication assisted treatment (MAT) for opioid use disorder on functional outcomes: A systematic review. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Barriers and facilitators to implementing medications for opioid use disorder and naloxone distribution in Veterans Affairs emergency departments. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Risk of motor vehicle collisions after methadone use. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Indian Health Service pharmacists engaged in opioid safety initiatives and expanding access to naloxone. [2017]

12. United States pubmed.ncbi.nlm.nih.gov

Strategies to recruit rural primary care providers to implement a medication for opioid use disorder (MOUD) focused integrated care model. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Bupreorphine:a new pharmacotherapy for opioid addictions treatment. [2013]

14. United States pubmed.ncbi.nlm.nih.gov

Perceived Ability to Treat Opioid Use Disorder in West Virginia. [2022]