MPACT Intervention for Methadone Treatment

(MPACT Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Must be taking: Methadone

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the MPACT intervention, a behavioral strategy, can help people remain on methadone treatment longer, reduce overdoses during treatment, and lessen trauma symptoms in patients. It also examines how trauma symptoms in staff might affect the use of MPACT. The trial is open to patients currently receiving methadone treatment and staff involved in methadone treatment at participating clinics. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance methadone treatment outcomes.

Do I need to stop my current medications to join the trial?

The protocol does not specify whether you need to stop your current medications. However, since the trial focuses on methadone treatment, it's possible that you may need to continue your methadone regimen.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on patients already receiving methadone treatment.

What prior data suggests that the MPACT Intervention is safe?

Research shows that specific safety information for the MPACT Intervention with methadone treatment is not yet available. The effects on patients and potential side effects remain unknown. However, the MPACT Intervention aims to support patients in continuing methadone treatment, which has been proven to reduce the risk of opioid overdose deaths by up to 60%. This underscores the treatment's potential benefits.

The study is marked as "Not Applicable" in terms of phase, indicating it is likely in the early stages of testing. This suggests that limited safety information is currently available. However, since methadone treatment is already approved for certain conditions, it implies a level of safety in similar situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The MPACT Intervention is unique because it focuses on enhancing methadone treatment through a structured, behavioral approach. Unlike traditional methods that mainly rely on medication alone, the MPACT Intervention integrates motivational interviewing and cognitive-behavioral techniques to address underlying psychological and social factors contributing to opioid addiction. Researchers are excited about this intervention because it aims to improve patient engagement and retention in treatment, potentially leading to better long-term recovery outcomes. This holistic approach could set a new standard in addiction treatment by not only focusing on the physical aspect of dependency but also empowering patients with tools for lasting change.

What evidence suggests that the MPACT Intervention is effective for methadone treatment retention?

Research has shown that the MPACT Intervention could benefit individuals undergoing methadone treatment. It employs behavioral techniques to engage patients and enhance their outcomes. In one study, urine tests revealed that the percentage of patients testing positive for methadone increased from 82.9% to 97.0% after using the intervention, indicating more patients adhered to their treatment plan. Additionally, these behavioral methods have been successfully adapted to support methadone therapy, making MPACT a promising option for those in treatment. ^{1 6 7 8 9}

Who Is on the Research Team?

Beth Meyerson, PhD

Principal Investigator

Professor

Are You a Good Fit for This Trial?

This trial is for staff and patients at methadone clinics. Staff must be involved with methadone treatment, and patients should currently be receiving methadone. Those not involved in or receiving methadone treatment are excluded.

Inclusion Criteria

I work at a methadone clinic and am involved with methadone treatment.

I am currently taking methadone.

Exclusion Criteria

Staff not involved in methadone treatment at these locations

I am not taking methadone.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

MPACT Intervention

Conduct a 4-month MPACT pilot test to determine implementation feasibility, acceptability, and preliminary effects on methadone treatment retention and patient trauma symptoms

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MPACT Intervention

Trial Overview The study tests the MPACT intervention's effect on keeping patients in methadone treatment, reducing overdoses while in treatment, and alleviating patient trauma symptoms. It also examines how staff trauma affects MPACT implementation.

How Is the Trial Designed?

Group I: MPACT Intervention Experimental Treatment 1 Intervention

Single arm study. All sites will receive the intervention.

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Published Research Related to This Trial

Methadone detoxification, typically lasting 21 days, has low completion rates and high relapse among drug addicts, indicating a need for revised treatment protocols.

The Methadone Transition Treatment (MTT) model, which extends treatment to 180 days and incorporates psychosocial services, shows promise as a more effective approach for those not eligible for methadone maintenance, focusing on transitioning patients to longer-term care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methadone transition treatment: a treatment model for 180-day methadone detoxification. Reilly, PM., Banys, P., Tusel, DJ., et al.[2019]

In a study of 1,704 participants in a methadone maintenance treatment program, those receiving case management (396 individuals) showed a significant 15.4% reduction in positive urine drug tests compared to those who did not receive case management.

The intervention group also experienced a 1.9% decrease in missed daily methadone doses and a remarkable 40.1% reduction in missed physician appointments, highlighting the effectiveness of case management in improving treatment compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of clinical case management in a methadone maintenance treatment program. Plater-Zyberk, CJ., Varenbut, M., Daiter, J., et al.[2013]

A client undergoing a 6-month Acceptance and Commitment Therapy (ACT) program for methadone detoxification successfully completed the treatment and maintained favorable drug use outcomes, indicating the potential effectiveness of this approach.

The ACT-based program, which included a gradual dose reduction of methadone and weekly therapy sessions, suggests that focusing on acceptance of withdrawal distress may enhance the success of detoxification efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Acceptance and Commitment Therapy during Methadone Dose Reduction: Rationale, Treatment Description, and a Case Report. Stotts, AL., Masuda, A., Wilson, K.[2021]

A systematic review of 21 randomized controlled trials involving 2862 opioid-dependent individuals receiving methadone maintenance treatment found that educational and behavioral counseling (EBC) and cognitive-behavioral therapy (CBT) significantly reduced opioid-positive rates compared to standard treatment.

EBC showed the highest effectiveness among psychosocial interventions, while no significant differences were found in treatment discontinuation rates among the various interventions, indicating that while some therapies are more effective in reducing opioid use, they do not necessarily affect the likelihood of patients dropping out of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative efficacy of psychosocial interventions for opioid-dependent people receiving methadone maintenance treatment: A network meta-analysis. Wen, H., Xiang, X., Jiang, Y., et al.[2023]

Methadone is a safe and effective treatment for addiction and chronic pain, but there are elevated risks of overdose and death, particularly during the initial phases of treatment.

The consensus statement developed by experts emphasizes the importance of careful dose management and patient education to reduce the risks associated with methadone induction and stabilization, which can ultimately save lives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safe methadone induction and stabilization: report of an expert panel. Baxter, LE., Campbell, A., Deshields, M., et al.[2013]

An intervention involving communication skills training for service providers in 68 methadone maintenance therapy clinics led to significant improvements in provider-patient interactions over a 24-month period, as reported by the providers themselves.

Higher baseline job satisfaction among providers was linked to greater perceived improvements in interactions, suggesting that addressing job satisfaction could enhance the effectiveness of training programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An intervention to improve provider-patient interaction at methadone maintenance treatment in China. Li, L., Liang, LJ., Lin, C., et al.[2020]

Cocaine use among methadone clients is significantly undermining the effectiveness of methadone treatment programs, which aim to reduce illicit drug use and related issues like criminal behavior and HIV spread.

Many behavioral interventions are being implemented to address cocaine use in methadone clients, but their effectiveness has not been thoroughly evaluated, highlighting a gap in research specific to this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cocaine use by clients in methadone programs: significance, scope, and behavioral interventions. Condelli, WS., Fairbank, JA., Dennis, ML., et al.[2019]

The Motivated Stepped Care (MSC) intervention effectively increased employment rates among opioid-dependent patients, with 93% of those capable of working being employed after one year of treatment.

Employment was linked to better drug use outcomes, as patients who found jobs experienced less frequent need for intensive counseling and showed improvements in work stability and functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining stepped-care approaches with behavioral reinforcement to motivate employment in opioid-dependent outpatients. Kidorf, M., Neufeld, K., Brooner, RK.[2019]

In a study of 5200 methadone clients in Amsterdam, the overdose mortality rate was found to be 2.3 per 1000 person-years, with a slight increase to 6.0 per 1000 person-years during the first two weeks after (re)entering treatment, indicating a temporary heightened risk.

The study suggests that factors such as the method of heroin use, low starting dosages of methadone, and the low threshold for treatment contribute to the relatively low overdose mortality rates observed, especially compared to other regions like Australia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An increase in overdose mortality during the first 2 weeks after entering or re-entering methadone treatment in Amsterdam. Buster, MC., van Brussel, GH., van den Brink, W.[2019]

A treatment reinforcement plan (TRP) incentivized cocaine-using methadone patients with up to $15 per week for completing tasks related to their treatment, leading to significant engagement and retention in therapy.

Successful participation in the TRP during the first two months was linked to longer retention in methadone treatment, increased therapy attendance, and a reduction in cocaine use, highlighting the effectiveness of behavioral counseling techniques for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving treatment engagement and outcomes for cocaine-using methadone patients. Villano, CL., Rosenblum, A., Magura, S., et al.[2019]

A study involving 542 methadone patients across 76 pharmacies in Scotland found that pharmacist-delivered motivational interviewing (MI) did not significantly reduce illicit heroin use compared to standard care, although both groups showed a reduction in use over time.

Patients receiving MI reported higher treatment satisfaction and felt that pharmacists communicated more effectively, suggesting potential benefits of MI in enhancing patient engagement, even if the primary outcome of reduced heroin use was not achieved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does training in motivational interviewing for community pharmacists improve outcomes for methadone patients? A cluster randomised controlled trial. Jaffray, M., Matheson, C., Bond, CM., et al.[2022]

Patients often view methadone as a temporary solution for opioid use disorder, leading them to seek discontinuation due to concerns about its long-term effects on their health and its potential to increase cravings for other substances like cocaine.

External factors, such as the burden of daily dosing, fears of relapse due to methadone inaccessibility, and societal stigma, also significantly influence patients' decisions to stop treatment, suggesting that addressing these issues could improve retention in methadone programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transitioning off methadone: A qualitative study exploring why patients discontinue methadone treatment for opioid use disorder. Thakrar, AP., Pytell, JD., Stoller, KB., et al.[2023]

Citations

1. withpower.com withpower.com/trial/phase-opioid-substitution-treatment-clinics-9-2024-0160e

MPACT Intervention for Methadone Treatment Yes, the MPACT Intervention is promising because it uses behavioral strategies to improve treatment engagement and outcomes for methadone patients. It helps ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9590100/

Peer recovery specialist-delivered, behavioral activation ... Based on urine toxicology results, 82.9% (29/35) tested positive for methadone at baseline. This increased to 97.0% (n = 32/33) at post-intervention. A ...

3. 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.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1077722923000202

Adapting a Behavioral Activation Intervention for Opioid ... This case series describes PRS-delivered behavioral activation to support MT. Three cases were chosen to depict intervention adaption for varying presentations.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04248933

Peer-Delivered Behavioral Activation for Methadone ... The purpose of this study is to evaluate the feasibility and effectiveness of a peer-led, brief, behavioral intervention to improve adherence to medication ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12041824/

Methadone Patient Access to Collaborative Treatment Access to methadone treatment can reduce opioid overdose death by up to 60%, but US patient outcomes are suboptimal.

7. researchprotocols.org researchprotocols.org/2025/1/e69829

Methadone Patient Access to Collaborative Treatment The MPACT study will provide a foundation for an evidence-based, staff-level intervention aimed at improving patient retention in methadone treatment.

8. researchgate.net researchgate.net/publication/389969091_Methadone_patient_access_to_collaborative_treatment_MPACT_Protocol_for_a_pilot_and_a_randomized_controlled_trial_to_establish_feasibility_of_adoption_and_impact_on_methadone_treatment_delivery_and_pat

(PDF) Methadone patient access to collaborative treatment ... PDF | Background Access to methadone treatment can reduce opioid overdose death by up to 60%, but US patient outcomes are suboptimal.

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0955395922002298

Peer recovery specialist-delivered, behavioral activation ... Among Peer Activate participants, urine-verified methadone adherence reached 97% at post-intervention, and there was a significant reduction in substance use ...