Opioid Use DisorderMPACTNCT06556602
Methadone Patient Access to Collaborative Treatment
A study testing MPACT in people with Opioid Use Disorder and Staff, run by University of Arizona at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Use Disorder, Staff, Patients
- What is being tested?
- MPACT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,080 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2026to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Staff providing methadone treatment services at the enrolled opioid treatment programs
Who cannot join
- Patients receiving methadone treatment at the enrolled opioid treatment programs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Arizona College of Nursing
Tucson, Arizona, 85714
Beth Meyerson, PhD, 520-626-0275, bmeyerson@arizona.edu
Beth Meyerson, PhD
About this study
Official title: Methadone Patient Access to Collaborative Treatment (MPACT)
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.
Read the detailed description
This MPACT trial will involve finalizing the refined MPACT intervention (materials, training) and conducting a Hybrid Type 1, 15-month cluster randomized controlled trial in 30 clinics with 600 patients (20/clinic) and 480 staff (18/clinic) to assess MPACT effect on patient outcomes and examine the relationship between staff trauma outcomes and MPACT implementation. R33 Specific AIMS:
AIM 1: Quantify the effects of MPACT on methadone treatment (MMT) practice change and opioid treatment program (OTP) culture.
AIM 2: Determine the efficacy of MPACT on MMT retention, in-MMT overdose and patient and staff post traumatic stress symptoms (PTSS) outcomes.
AIM 3: Evaluate the effect of patient and staff trauma symptoms on primary outcomes and staff MPACT implementation.
- Conditions
- Opioid Use Disorder, Staff, Patients
- Being tested
- MPACT
- Keywords
- Methadone
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPACTOther
Four components are part of this intervention: 1) accredited training about patient centered, trauma-informed care and the standard of care under the current federal regulation (42CFRpart8), 2) education about trauma and trauma symptoms including vicarious (work related) trauma and navigation to symptoms screening and resources including treatment, 3) reflective supervision for counseling, case management and peer staff, and 4) clinic self assessment for trauma-informed and patient centered care
| Study group | Role | What they receive |
|---|---|---|
| MPACT Intervention | Experimental | 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. Receives: Other: MPACT |
| Control for MPACT | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days in Treatment to treatment interruption
Time (days) to treatment interruption
Measured: 18 months
Missed doses
Missed methadone doses in the last 30 days
Measured: 20 months
In Treatment- Point in time
Point in time in treatment (0 day, 30 day, 60, day, 90 day)
Measured: 18 months
Number of patients reporting opioid overdoses while in methadone treatment
Reported overdoses by patients in methadone treatment during the trial period by survey measured at 5 points during the study period.
Measured: 18 months
Secondary outcomes (2)
Number of staff experiencing vicarious (work related) stress
Post traumatic stress symptoms and vicarious (work related) trauma symptoms measured by the Vicarious Trauma Scale (VTS). Total scores can be grouped into three categories to represent low (8-28), moderate (29-42) and high (43-56) levels of vicarious trauma symptoms
Measured: 18 months
Number of patients and staff experiencing post traumatic stress symptoms
Post traumatic stress symptoms measured by the 8-item PCL-5 measuring post traumatic stress symptoms. Scores range from 0-80, with higher scores representing greater levels of traumatic stress symptomatology.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start5 Feb 2026
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Hybrid Type 1, 20-month simultaneous cluster randomized controlled trial in 36 clinics
- Masking
- None (open label)
- Enrolment
- 1,080 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556602
- Sponsor's protocol ID
- 456483
- Acronym
- MPACT
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2024
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A Data Management and Sharing Plan has been filed with the National Institute on Drug Abuse.
Publications
Meyerson BE, Davis A, Crosby RA, Linde-Krieger LB, Brady BR, Carter GA, Mahoney AN, Frank D, Rothers J, Coffee Z, Deuble E, Ebert J, Jablonsky MF, Juarez M, Lee B, Lorenz HM, Pava MD, Tinsely K, Yousaf S. Methadone Patient Access to Collaborative Treatment: Protocol for a Pilot and a Randomized Controlled Trial to Establish Feasibility of Adoption and Impact on Methadone Treatment Delivery and Patient Outcomes. JMIR Res Protoc. 2025 Apr 15;14:e69829. doi: 10.2196/69829.
PubMed 40105313
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methadone Patient Access to Collaborative Treatment (MPACT)
- ClinicalTrials.gov ID
- NCT06556602
- Acronym / sponsor ID
- MPACT / 456483
- Conditions
- Opioid Use Disorder, Staff, Patients
- Keywords
- Methadone
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,080 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 16 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This MPACT trial will involve finalizing the refined MPACT intervention (materials, training) and conducting a Hybrid Type 1, 15-month cluster randomized controlled trial in 30 clinics with 600 patients (20/clinic) and 480 staff (18/clinic) to assess MPACT effect on patient outcomes and examine the relationship between staff trauma outcomes and MPACT implementation. R33 Specific AIMS:
AIM 1: Quantify the effects of MPACT on methadone treatment (MMT) practice change and opioid treatment program (OTP) culture.
AIM 2: Determine the efficacy of MPACT on MMT retention, in-MMT overdose and patient and staff post traumatic stress symptoms (PTSS) outcomes.
AIM 3: Evaluate the effect of patient and staff trauma symptoms on primary outcomes and staff MPACT implementation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Hybrid Type 1, 20-month simultaneous cluster randomized controlled trial in 36 clinics
| Arm | Type | Receives |
|---|---|---|
| MPACT Intervention | Experimental | Other: MPACTEnrolled 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. |
| Control for MPACT | No 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Staff providing methadone treatment services at the enrolled opioid treatment programs
Key exclusion criteria (1 listed)
- Patients receiving methadone treatment at the enrolled opioid treatment programs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MPACTFour components are part of this intervention: 1) accredited training about patient centered, trauma-informed care and the standard of care under the current federal regulation (42CFRpart8), 2) education about trauma and trauma symptoms including vicarious (work related) trauma and navigation to symptoms screening and resources including treatment, 3) reflective supervision for counseling, case management and peer staff, and 4) clinic self assessment for trauma-informed and patient centered care | Other | MPACT Intervention |
Primary outcome
Days in Treatment to treatment interruption
Time frame: 18 months
Time (days) to treatment interruption
Missed doses
Time frame: 20 months
Missed methadone doses in the last 30 days
In Treatment- Point in time
Time frame: 18 months
Point in time in treatment (0 day, 30 day, 60, day, 90 day)
Number of patients reporting opioid overdoses while in methadone treatment
Time frame: 18 months
Reported overdoses by patients in methadone treatment during the trial period by survey measured at 5 points during the study period.
2 secondary outcomes
Number of staff experiencing vicarious (work related) stress
Time frame: 18 months
Number of patients and staff experiencing post traumatic stress symptoms
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Derived from this study: PubMed 40105313Meyerson BE, Davis A, Crosby RA, Linde-Krieger LB, Brady BR, Carter GA, Mahoney AN, Frank D, Rothers J, Coffee Z, Deuble E, Ebert J, Jablonsky MF, Juarez M, Lee B, Lorenz HM, Pava MD, Tinsely K, Yousaf S. Methadone Patient Access to Collaborative Treatment: Protocol for a Pilot and a Randomized Controlled Trial to Establish Feasibility of Adoption and Impact on Methadone Treatment Delivery and Patient Outcomes. JMIR Res Protoc. 2025 Apr 15;14:e69829. doi: 10.2196/69829.
- Individual participant dataSharing planned: Yes. A Data Management and Sharing Plan has been filed with the National Institute on Drug Abuse.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MPACT in people with Opioid Use Disorder and Staff, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days in Treatment to treatment interruption (time frame: 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06556602, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.