Opioid Substitution Treatment ClinicsMPACTNCT06513728
Pilot Study of Methadone Patient Access to Collaborative Treatment: a HEAL Initiative
A study testing MPACT Intervention in people with Opioid Substitution Treatment Clinics and Patients, run by University of Arizona at 1 site in United States.
Trial summary
Examine the preliminary effect of the MPACT intervention on methadone treatment retention, in treatment overdose and patient trauma symptoms. The study will also explore the relationship between staff trauma symptoms and MPACT implementation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Substitution Treatment Clinics, Patients, Staff
- What is being tested?
- MPACT Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 of enrolled opioid treatment programs (methadone clinics) who are involved with methadone treatment
- Patients receiving methadone at these locations
Who cannot join
- Patients not receiving methadone at these locations
- Staff not involved in methadone treatment at these locations
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arizona College of Medicine
Tucson, Arizona, 85714
About this study
Official title: Methadone Patient Access to Collaborative Treatment
Examine the preliminary effect of the MPACT intervention on methadone treatment retention, in treatment overdose and patient trauma symptoms. The study will also explore the relationship between staff trauma symptoms and MPACT implementation.
Read the detailed description
Specific AIMS:
AIM 1: Develop MPACT through multilevel, iterative planning with OTP staff and people with recent MMT experience.
AIM 2: Conduct a 4-month MPACT pilot test in two AZ OTPs: Mesa (urban) with 50 patients and 22 staff, and Sierra Vista (rural-serving) with 50 patients and 8 staff to:
- Determine MPACT implementation feasibility, acceptability, and preliminary effect on MMT practice change and culture.
- Determine MPACT preliminary effect on MMT retention, in-MMT overdose, and patient PTSS.
- Characterize staff trauma history, PTSS and vicarious trauma, and explore their relationship with MPACT acceptability and implementation fidelity.
AIM 3: Characterize MPACT acceptability, likely adoption, and recruitment feasibility among directors, case managers and counselors from a national random sample of 500 OTPs.
- Conditions
- Opioid Substitution Treatment Clinics, Patients, Staff
- Being tested
- MPACT Intervention
- Keywords
- Implementation Science, Methadone treatment, Opioid Use Disorder, Opioid Use Disorder Treatment, Workforce Development, Vicarious trauma, Posttraumatic stress, Treatment retention
- Medical subject headings
- Opioid-Related Disorders, Compassion Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPACT InterventionOther
MPACT has 4 components: accredited training about patient centered, trauma informed methadone treatment, staff education about trauma symptoms with navigation to self screening and treatment or stress management, clinic self assessment tools for trauma informed, patient centered care, and reflective supervision for counselors, case managers and peer staff.
| Study group | Role | What they receive |
|---|---|---|
| MPACT Intervention | Experimental | Single arm study. All sites will receive the intervention. Receives: Other: MPACT Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
methadone treatment retention
Retention in methadone treatment (measured by 3 different indicators)
Measured: 4 months (pilot study period)
In treatment overdose
Reported overdoses during methadone treatment (measured by study constructed algorithm)
Measured: 4 months (pilot study period)
Secondary outcomes (2)
Trauma symptoms among patients and staff
Post traumatic stress symptoms (measured by 8-item Post Traumatic Stress Disorder Checklist or, PCL-5). Scores are 0-80. Higher scores mean greater PTSD symptom severity.
Measured: pilot period of 4 months
Vicarious Trauma symptoms among staff
Vicarious trauma symptoms (measured by the Vicarious Trauma Scale (VTS). Scores are 0-190. Higher scores indicate more vicarious (work related) traumatization.
Measured: pilot period of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start26 Sep 2024
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
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 Substitution Treatment ClinicsStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a pilot implementation and preliminary effectiveness study of MPACT.
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beth Meyerson, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513728
- Sponsor's protocol ID
- 456482
- Acronym
- MPACT
- Status last verified
- May 2025
- First submitted
- 16 Jul 2024
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A Data Sharing and Management Plan was submitted to NIDA for this study. please see that submission.
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 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methadone Patient Access to Collaborative Treatment
- ClinicalTrials.gov ID
- NCT06513728
- Acronym / sponsor ID
- MPACT / 456482
- Conditions
- Opioid Substitution Treatment Clinics, Patients, Staff
- Keywords
- Implementation Science, Methadone treatment, Opioid Use Disorder, Opioid Use Disorder Treatment, Workforce Development, Vicarious trauma, Posttraumatic stress, Treatment retention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 26 Sep 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 22 Jul 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.
Examine the preliminary effect of the MPACT intervention on methadone treatment retention, in treatment overdose and patient trauma symptoms. The study will also explore the relationship between staff trauma symptoms and MPACT implementation.
Detailed description
Specific AIMS:
AIM 1: Develop MPACT through multilevel, iterative planning with OTP staff and people with recent MMT experience.
AIM 2: Conduct a 4-month MPACT pilot test in two AZ OTPs: Mesa (urban) with 50 patients and 22 staff, and Sierra Vista (rural-serving) with 50 patients and 8 staff to:
- Determine MPACT implementation feasibility, acceptability, and preliminary effect on MMT practice change and culture.
- Determine MPACT preliminary effect on MMT retention, in-MMT overdose, and patient PTSS.
- Characterize staff trauma history, PTSS and vicarious trauma, and explore their relationship with MPACT acceptability and implementation fidelity.
AIM 3: Characterize MPACT acceptability, likely adoption, and recruitment feasibility among directors, case managers and counselors from a national random sample of 500 OTPs.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a pilot implementation and preliminary effectiveness study of MPACT.
| Arm | Type | Receives |
|---|---|---|
| MPACT Intervention | Experimental | Other: MPACT InterventionSingle arm study. All sites will receive the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Staff of enrolled opioid treatment programs (methadone clinics) who are involved with methadone treatment
- Patients receiving methadone at these locations
Key exclusion criteria (2 listed)
- Patients not receiving methadone at these locations
- Staff not involved in methadone treatment at these locations
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 |
|---|---|---|
| MPACT InterventionMPACT has 4 components: accredited training about patient centered, trauma informed methadone treatment, staff education about trauma symptoms with navigation to self screening and treatment or stress management, clinic self assessment tools for trauma informed, patient centered care, and reflective supervision for counselors, case managers and peer staff. | Other | MPACT Intervention |
Primary outcome
methadone treatment retention
Time frame: 4 months (pilot study period)
Retention in methadone treatment (measured by 3 different indicators)
In treatment overdose
Time frame: 4 months (pilot study period)
Reported overdoses during methadone treatment (measured by study constructed algorithm)
2 secondary outcomes
Trauma symptoms among patients and staff
Time frame: pilot period of 4 months
Vicarious Trauma symptoms among staff
Time frame: pilot period of 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- 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 Sharing and Management Plan was submitted to NIDA for this study. please see that submission.
Related trials for Opioid Substitution Treatment Clinics
Recruiting
ETHOS ENGAGE: Enhancing Treatment of Hepatitis C in Opioid Substitution Settings
Hepatitis C
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. This study is not recruiting at the moment.
Beth Meyerson, PhD principal investigator
Professor
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 Intervention in people with Opioid Substitution Treatment Clinics and Patients, 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 8 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
methadone treatment retention (time frame: 4 months (pilot study period)). The study lists 2 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 NCT06513728, 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 8 Aug 2025.