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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called MPACT to evaluate its impact on methadone treatment retention and overdose prevention. It also examines how the program addresses trauma symptoms in both patients and clinic staff and whether it alters clinic operations. The trial includes two groups: one where staff implement the MPACT program and one where they do not. Only staff providing methadone treatment at specific clinics can participate in this study. As an unphased trial, this study presents a unique opportunity to contribute to innovative research that could enhance methadone treatment and clinic operations.

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 prior data suggests that the MPACT intervention is safe for opioid use disorder treatment?

Research has shown that programs like MPACT can help people with opioid addiction stay in treatment longer and use fewer drugs. For instance, one study found that similar programs kept 85% of participants in treatment for over six months. Another study showed that many participants tested negative for opioids after joining these programs.

Regarding safety, MPACT is not a medication but a support and training program for clinic staff, reducing concerns about side effects. MPACT focuses on enhancing the support system for patients through training and wellness education. This approach is generally low-risk because it doesn't involve taking new drugs.

Overall, while the exact effects of MPACT are still under study, similar programs have been well-received by participants and have shown positive results in helping people with opioid addiction. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MPACT program for opioid use disorder because it offers a comprehensive approach that goes beyond traditional medication-assisted treatments like methadone and buprenorphine. Unlike these standard treatments, MPACT focuses on integrating wellness education and trauma-informed care into the recovery process. This includes training for clinic staff, reflective supervision, and assessments that guide patients to appropriate trauma resources. By addressing the psychological and emotional roots of addiction, MPACT aims to improve long-term recovery outcomes, making it a promising new avenue for treating opioid use disorder.

What evidence suggests that the MPACT intervention could be effective for opioid use disorder?

This trial will compare the MPACT intervention with a control group. Although the trial does not involve methadone treatment, studies have shown that methadone reduces overdoses and serious health problems related to opioid use. Research indicates that people on methadone have a much lower risk of dying from any cause, including overdoses. Evidence also shows that medications like methadone can improve physical and mental health over time. In one study, 85% of patients remained in treatment for six months, and most had drug-free test results. This suggests methadone can be a powerful tool in managing opioid use disorder. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK541393/

The Effectiveness of Medication-Based Treatment for Opioid ... Both methadone and buprenorphine treatment retention have been linked to substantially decreased risks of both all-cause and overdose-related mortality among ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2760032

Comparative Effectiveness of Different Treatment Pathways ... Treatment with buprenorphine or methadone was associated with reductions in overdose and serious opioid-related acute care use compared with other treatments.

3. substanceabusepolicy.biomedcentral.com substanceabusepolicy.biomedcentral.com/articles/10.1186/s13011-021-00424-4

Outcomes from the medication assisted treatment pilot ... This study shows decreased substance use, improved physical and mental health, and reduced symptoms after 6 months of MOUD.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2949875925001237

Evaluation of a primary care-based Medication for Opioid ... Data collected from July 1, 2022 to December 31, 2022 showed a 6-month retention rate of 85 % (N = 186). Urine drug screens were opioid-negative for 91 % of ...

5. cdc.gov cdc.gov/mmwr/volumes/73/wr/mm7325a1.htm

Treatment for Opioid Use Disorder: Population Estimates In 2022, 3.7% of US adults aged ≥18 years needed OUD treatment. Among these, only 25.1% received medications for OUD.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10993074/

Public Health Interventions and Overdose-Related ... This decision analytical model estimates the projected 3-year association between public health interventions and opioid overdose-related outcomes

7. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-025-06722-6

Impact of an opioid use disorder medication implementation ... This evaluation did not find evidence that SCOUTT substantially impacted hospitalization or ED utilization relative to comparison clinics.

8. psychiatryonline.org psychiatryonline.org/doi/full/10.1176/appi.ajp.20230918

Harm Reduction for Opioid Use Disorder: Strategies and ... Although outcomes are challenging to track, data routinely suggest that these programs dispense thousands of doses of naloxone and are ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8389722/

Medication Assisted Treatment for Opioid Use Disorder MAT has been shown to improve life functioning and decrease heroin and other opioid use; criminal behavior; drug use practices, such as needle sharing, that ...