Opioid Use DisorderMBC2OTPNCT06345274
MBC2OTP Project (Measurement-Based Care Implementation in Community Opioid Treatment Programs)
A study testing Measurement Based Care Training and Monthly Consultation in people with Opioid Use Disorder, run by Northwestern University at 5 sites in United States.
Trial summary
The goal of this clinical trial is to evaluate the effectiveness and implementation of measurement-based care, which involves the systematic use of client self-report data to inform and enhance treatment, in opioid treatment programs using a pilot hybrid effectiveness-implementation study design. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Measurement Based Care Training and Monthly Consultation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 5 sitesUnited States
- Study dates
- 24 Apr 2024to 14 Apr 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide supervision or oversight to treatment providers or provide administrative oversight at the OTP
- Conduct supervision or oversight primarily in English
- Are considered a treatment provider at the OTP providing direct patient care
- Conduct treatment primarily in English
- Exclusion Criteria (Opioid Treatment Program Leaders and Providers):
- Exclusion criteria are minimal to enhance generalizability and enable participation of all leaders and treatment providers overseeing or delivering care at each opioid treatment program. Providers and leaders will be excluded if they do not conduct treatment in English, as the measurement-based care assessment tool is written in the English language.
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- Inclusion Criteria (Persons receiving treatment at Opioid Treatment Programs [Not recruited, via electronic medical records only]):
- Must be a new patient at the opioid treatment program in the 6 months pre or post measurement-based care implementation
- Exclusion Criteria (Persons receiving treatment at Opioid Treatment Programs [Not recruited, via electronic medical records only]):
- Younger than 18 years of age
- Does not have electronic medical records
Who cannot join
None listed.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Family Guidance Centers, Inc.
Aurora, Illinois, 60505
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Family Guidance Centers, Inc.
Chicago, Illinois, 60654
Family Guidance Centers, Inc.
Des Plaines, Illinois, 60016
Family Guidance Centers, Inc.
Joliet, Illinois, 60435
About this study
Official title: Pilot Implementation of Measurement-Based Care in Community Opioid Treatment Programs
The goal of this clinical trial is to evaluate the effectiveness and implementation of measurement-based care, which involves the systematic use of client self-report data to inform and enhance treatment, in opioid treatment programs using a pilot hybrid effectiveness-implementation study design. The main questions this study aims to answer are: 1) is measurement based care effective for improving patient treatment attendance and opioid abstinence, and 2) can measurement based care be implemented with fidelity in opioid treatment programs? Participants in this study will be opioid treatment program leaders and treatment providers. Leaders and treatment providers will participate in measurement-based care implementation strategies such as training and consultation to help them use measurement-based care with their patients. There is no comparison group for this study, however researchers will compare effectiveness outcomes prior to and post measurement-based care implementation and will evaluate changes in measurement-based care use with fidelity post implementation.
Read the detailed description
Lethal drug overdoses have now become a leading cause of accidental death in the United States. The gold standard, evidence-based intervention for opioid use disorder (OUD) is pharmacotherapy, but abstinence rates following pharmacotherapy are sub-optimal. In fact, less than 40% of clients with OUD achieve abstinence in the first six months of treatment, highlighting the critical need to supplement pharmacotherapy with evidence-based psychosocial interventions. Unfortunately, very few community opioid treatment programs (OTPs) offer psychosocial interventions due to high patient volume and the need to identify behavioral treatments that can be flexibly delivered. Measurement-based care (MBC), the systematic use of client self-report data to inform treatment, is an evidence-based intervention that is uniquely well suited to complement OUD pharmacotherapy. Given the high lethality of opioid misuse, MBC provides an opportunity to identify early warning signs for poor treatment progress and enables treatment providers to intervene. Additionally, MBC may serve as a minimal intervention/intervention structure to increase the effectiveness of OUD treatment. Such structures have been proposed for implementation in community settings in lieu of full package evidence-based interventions to enhance feasibility and reduce barriers. The pressing need for flexible psychosocial interventions to complement pharmacotherapy, paired with the extensive evidence in support of MBC, makes it crucial to understand ways to implement and evaluate MBC's effectiveness in OTPs. This study involves a pilot type I hybrid effectiveness-implementation study with four OTPs.
Study Aim and Hypotheses are:
Aim: Pilot MBC effectiveness-implementation trial in community OTPs. Four OTPs will participate in a pilot hybrid type 1 effectiveness-implementation trial in which an MBC assessment protocol will be integrated into each OTP's electronic medical record (EMR). The pilot trial will gather data on MBC's effectiveness (outcomes: patient attendance and opioid abstinence) and implementation (outcomes: provider MBC exposure and fidelity). The study hypotheses are that post MBC EMR integration, patients will attend more treatment appointments (H1) and have more negative opioid urine screens per month (H2) compared to pre-EMR integration patients. Provider MBC exposure and fidelity will also be positively associated with higher attendance and abstinence across all sites (H3).
- Conditions
- Opioid Use Disorder
- Being tested
- Measurement Based Care Training and Monthly Consultation
- Keywords
- Opioid Use Disorder, Opioid Treatment Programs, Measurement-Based Care, Implementation Science
- 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.
Measurement Based Care Training and Monthly ConsultationBehavioural
Participating opioid treatment program leaders and treatment providers will receive two measurement-based care implementation strategies: 1) didactic training including a total of four hours of workshop training led by a measurement-based care expert, and 2) monthly consultation calls led by a measurement-based care expert for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Measurement Based Care Implementation | Experimental | All participating opioid treatment programs will receive this arm. Receives: Behavioral: Measurement Based Care Training and Monthly Consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient treatment attendance (effectiveness outcome)
Treatment attendance will include both completion of medication for opioid use disorder (MOUD) dosing visits and attendance at treatment sessions. Data to be extracted from opioid treatment program electronic medical records include the number of treatment sessions/visits attended for each patient (e.g., MOUD dosing visits and individual/group counseling appointments) and the total number of treatment visits scheduled for each patient.
Measured: Assessed for 6 months for each patient both pre and post measurement based care implementation. Data will be extracted from the opioid treatment program electronic medical record.
Patient treatment attendance (effectiveness outcome)
Treatment attendance will include both completion of medication for opioid use disorder (MOUD) dosing visits and attendance at treatment sessions. Data to be extracted from opioid treatment program electronic medical records include the the total number of weeks each patient was retained in treatment after an initial intake appointment.
Measured: Assessed for 6 months for each patient both pre and post measurement based care implementation. Data will be extracted from the opioid treatment program electronic medical record.
Treatment provider measurement based care exposure (implementation outcome)
The total number of monthly completed counseling or treatment sessions delivered by treatment providers will be extracted from the opioid treatment program electronic medical record. The research team will compute monthly MBC exposure values by dividing the total number of sessions with MBC administration documentation by the total number of sessions completed for each patient.
Measured: Assessed for 6 months for each patient post measurement based care implementation. Data will be extracted from the opioid treatment program electronic medical record.
Secondary outcomes (2)
Patient opioid abstinence (effectiveness outcome)
Data to be extracted from opioid treatment program electronic medical records include the number of positive and negative opioid use screens (e.g., urine screens and/or oral swabs) for each patient.
Measured: Assessed for 6 months for each patient both pre and post measurement based care implementation. Data will be extracted from the opioid treatment program electronic medical record.
Treatment provider measurement based care fidelity (implementation outcome)
Treatment providers will report in the opioid treatment program electronic medical record if they administered, reviewed, discussed the MBC measure, and/or reevaluated the treatment plan at each counseling or treatment session. The research team will calculate categorical fidelity scores for each completed counseling or treatment session. MBC fidelity scores will be calculated on a researcher created MBC fidelity scale from "0" (no MBC administered) to "3" (full MBC fidelity) where higher scores indicate better MBC fidelity.
Measured: Assessed for 6 months for each patient post measurement based care implementation. Data will be extracted from the opioid treatment program electronic medical record.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start24 Apr 2024
- Primary completion14 Apr 2026
- Study completion14 Apr 2026
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.
- More trials run by Northwestern UniversityThe 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
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Kelli Scott, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345274
- Sponsor's protocol ID
- SP0077172
- Other IDs
- K23DA050729
- Acronym
- MBC2OTP
- Status last verified
- Apr 2026
- First submitted
- 21 Mar 2024
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol and statistical analysis plan for this study was published in 2022 in the Addiction Science and Clinical Practice journal (https://doi.org/10.1186/s13722-022-00327-0). Additional data (analytic code, participant-level data) can be requested from the Principal Investigator. Analysis files will be constructed from the electronic data and will be stripped of identifying information. Specifically, participants will be identified with a numeric identifier that is not related to any element of their personal identifying information. No names, addresses, telephone numbers, email addresses, medical record numbers, etc. will be retained in the de-identified files.
Publications
Scott K, Guigayoma J, Palinkas LA, Beaudoin FL, Clark MA, Becker SJ. The measurement-based care to opioid treatment programs project (MBC2OTP): a study protocol using rapid assessment procedure informed clinical ethnography. Addict Sci Clin Pract. 2022 Aug 19;17(1):44. doi: 10.1186/s13722-022-00327-0.
PubMed 35986380
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Implementation of Measurement-Based Care in Community Opioid Treatment Programs
- ClinicalTrials.gov ID
- NCT06345274
- Acronym / sponsor ID
- MBC2OTP / SP0077172
- Conditions
- Opioid Use Disorder
- Keywords
- Opioid Use Disorder, Opioid Treatment Programs, Measurement-Based Care, Implementation Science
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 14 Apr 2026 (actual)
- Study completion
- 14 Apr 2026 (actual)
- First posted
- 3 Apr 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 goal of this clinical trial is to evaluate the effectiveness and implementation of measurement-based care, which involves the systematic use of client self-report data to inform and enhance treatment, in opioid treatment programs using a pilot hybrid effectiveness-implementation study design. The main questions this study aims to answer are: 1) is measurement based care effective for improving patient treatment attendance and opioid abstinence, and 2) can measurement based care be implemented with fidelity in opioid treatment programs? Participants in this study will be opioid treatment program leaders and treatment providers. Leaders and treatment providers will participate in measurement-based care implementation strategies such as training and consultation to help them use measurement-based care with their patients. There is no comparison group for this study, however researchers will compare effectiveness outcomes prior to and post measurement-based care implementation and will evaluate changes in measurement-based care use with fidelity post implementation.
Detailed description
Lethal drug overdoses have now become a leading cause of accidental death in the United States. The gold standard, evidence-based intervention for opioid use disorder (OUD) is pharmacotherapy, but abstinence rates following pharmacotherapy are sub-optimal. In fact, less than 40% of clients with OUD achieve abstinence in the first six months of treatment, highlighting the critical need to supplement pharmacotherapy with evidence-based psychosocial interventions. Unfortunately, very few community opioid treatment programs (OTPs) offer psychosocial interventions due to high patient volume and the need to identify behavioral treatments that can be flexibly delivered. Measurement-based care (MBC), the systematic use of client self-report data to inform treatment, is an evidence-based intervention that is uniquely well suited to complement OUD pharmacotherapy. Given the high lethality of opioid misuse, MBC provides an opportunity to identify early warning signs for poor treatment progress and enables treatment providers to intervene. Additionally, MBC may serve as a minimal intervention/intervention structure to increase the effectiveness of OUD treatment. Such structures have been proposed for implementation in community settings in lieu of full package evidence-based interventions to enhance feasibility and reduce barriers. The pressing need for flexible psychosocial interventions to complement pharmacotherapy, paired with the extensive evidence in support of MBC, makes it crucial to understand ways to implement and evaluate MBC's effectiveness in OTPs. This study involves a pilot type I hybrid effectiveness-implementation study with four OTPs.
Study Aim and Hypotheses are:
Aim: Pilot MBC effectiveness-implementation trial in community OTPs. Four OTPs will participate in a pilot hybrid type 1 effectiveness-implementation trial in which an MBC assessment protocol will be integrated into each OTP's electronic medical record (EMR). The pilot trial will gather data on MBC's effectiveness (outcomes: patient attendance and opioid abstinence) and implementation (outcomes: provider MBC exposure and fidelity). The study hypotheses are that post MBC EMR integration, patients will attend more treatment appointments (H1) and have more negative opioid urine screens per month (H2) compared to pre-EMR integration patients. Provider MBC exposure and fidelity will also be positively associated with higher attendance and abstinence across all sites (H3).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Measurement Based Care Implementation | Experimental | Behavioral: Measurement Based Care Training and Monthly ConsultationAll participating opioid treatment programs will receive this arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Provide supervision or oversight to treatment providers or provide administrative oversight at the OTP
- Conduct supervision or oversight primarily in English
- Are considered a treatment provider at the OTP providing direct patient care
- Conduct treatment primarily in English
- Exclusion criteria are minimal to enhance generalizability and enable participation of all leaders and treatment providers overseeing or delivering care at each opioid treatment program. Providers and leaders will be excluded if they do not conduct treatment in English, as the measurement-based care assessment tool is written in the English language.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Measurement Based Care Training and Monthly ConsultationParticipating opioid treatment program leaders and treatment providers will receive two measurement-based care implementation strategies: 1) didactic training including a total of four hours of workshop training led by a measurement-based care expert, and 2) monthly consultation calls led by a measurement-based care expert for 6 months. | Behavioural | Measurement Based Care Implementation |
Primary outcome
Patient treatment attendance (effectiveness outcome)
Time frame: Assessed for 6 months for each patient both pre and post measurement based care implementation. Data will be extracted from the opioid treatment program electronic medical record.
Treatment attendance will include both completion of medication for opioid use disorder (MOUD) dosing visits and attendance at treatment sessions. Data to be extracted from opioid treatment program electronic medical records include the number of treatment sessions/visits attended for each patient (e.g., MOUD dosing visits and individual/group counseling appointments) and the total number of treatment visits scheduled for each patient.
Patient treatment attendance (effectiveness outcome)
Time frame: Assessed for 6 months for each patient both pre and post measurement based care implementation. Data will be extracted from the opioid treatment program electronic medical record.
Treatment attendance will include both completion of medication for opioid use disorder (MOUD) dosing visits and attendance at treatment sessions. Data to be extracted from opioid treatment program electronic medical records include the the total number of weeks each patient was retained in treatment after an initial intake appointment.
Treatment provider measurement based care exposure (implementation outcome)
Time frame: Assessed for 6 months for each patient post measurement based care implementation. Data will be extracted from the opioid treatment program electronic medical record.
The total number of monthly completed counseling or treatment sessions delivered by treatment providers will be extracted from the opioid treatment program electronic medical record. The research team will compute monthly MBC exposure values by dividing the total number of sessions with MBC administration documentation by the total number of sessions completed for each patient.
2 secondary outcomes
Patient opioid abstinence (effectiveness outcome)
Time frame: Assessed for 6 months for each patient both pre and post measurement based care implementation. Data will be extracted from the opioid treatment program electronic medical record.
Treatment provider measurement based care fidelity (implementation outcome)
Time frame: Assessed for 6 months for each patient post measurement based care implementation. Data will be extracted from the opioid treatment program electronic medical record.
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 27 Apr 2026.
- Background: PubMed 35986380Scott K, Guigayoma J, Palinkas LA, Beaudoin FL, Clark MA, Becker SJ. The measurement-based care to opioid treatment programs project (MBC2OTP): a study protocol using rapid assessment procedure informed clinical ethnography. Addict Sci Clin Pract. 2022 Aug 19;17(1):44. doi: 10.1186/s13722-022-00327-0.
- Individual participant dataSharing planned: Yes. The study protocol and statistical analysis plan for this study was published in 2022 in the Addiction Science and Clinical Practice journal (https://doi.org/10.1186/s13722-022-00327-0). Additional data (analytic code, participant-level data) can be requested from the Principal Investigator. Analysis files will be constructed from the electronic data and will be stripped of identifying information. Specifically, participants will be identified with a numeric identifier that is not related to any element of their personal identifying information. No names, addresses, telephone numbers, email addresses, medical record numbers, etc. will be retained in the de-identified files.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement Based Care Training and Monthly Consultation in people with Opioid Use Disorder, run by Northwestern University at 5 sites 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 11 inclusion and 0 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 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Patient treatment attendance (effectiveness outcome) (time frame: Assessed for 6 months for each patient both pre and post measurement based care implementation. Data will be extracted from the opioid treatment program electronic medical record.). The study lists 3 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 NCT06345274, 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 27 Apr 2026.