Opioid-use DisorderMIMICNCT03931174
Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics)
A study testing Addiction Technology Transfer Center (ATTC) Training Strategy and Enhanced Addiction Technology Transfer Center (E-ATTC) Training Strategy in people with Opioid-use Disorder, run by Brown University at 29 sites in United States.
Trial summary
There is an urgent need for effective treatments for patients with opioid use disorder (OUD). This study will train opioid treatment programs in an evidence-based behavioral treatment called contingency management (CM). 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?
- Addiction Technology Transfer Center (ATTC) Training Strategy and Enhanced Addiction Technology Transfer Center (E-ATTC) Training Strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 780 participants
- Where
- 29 sitesUnited States
- Study dates
- 9 Apr 2019to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- adult patients
- newly admitted to the opioid treatment center within the past 30 days
- prescribed any FDA-approved OUD medication
Who cannot join
- None
- Inclusion criteria for CM Providers (n = 60-150, range of 2-5 per center):
- has been involved in providing psychosocial support to OUD patients on pharmacotherapy
- has an active caseload
- is willing to commit to 14 months of CM training and support
- None
Show all 11Show fewer
- Inclusion Criteria for CM Leaders (n = 30-60, range of 1-2 per center):
- is responsible for supervising frontline CM Staff
- is willing to commit to 14 months of external leadership coaching
- None
- issues that could interfere with the ability to complete a brief intake interview including acute intoxication, acute psychosis, acute mania, or cognitive impairment (prohibiting comprehension of the consent process), as reported by opioid treatment program staff or observed by research staff
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
BAART Programs Berlin
Berlin Corners, Vermont, 05602
Kinsella Treatment Center
Bridgeport, Connecticut, 06605
Liberation Programs Bridgeport
Bridgeport, Connecticut, 06610
North Charles Institute for the Addictions
Cambridge, Massachusetts, 02140
CODAC Behavioral Healthcare - Eleanor Slater
Cranston, Rhode Island, 02920
Habit Opco East Wareham Comprehensive Treatment Center
East Wareham, Massachusetts, 02538
Habit Opco Fall River Comprehensive Treatment Center
Fall River, Massachusetts, 02721
Spectrum Health Systems Framingham
Framingham, Massachusetts, 01702
Community Renewal Team
Hartford, Connecticut, 06120
Spectrum Health Systems Haverhill
Haverhill, Massachusetts, 01830
Spectrum Health Systems Leominster
Leominster, Massachusetts, 01453
Spectrum Health Systems Milford
Milford, Massachusetts, 01757
Spectrum Health Systems Millbury
Millbury, Massachusetts, 01527
Gifford Street Comprehensive Treatment Center
New Bedford, Massachusetts, 02744
Spectrum Health Systems North Adams
North Adams, Massachusetts, 01247
Spectrum Health Systems Pittsfield
Pittsfield, Massachusetts, 01201
Lifespan Recovery Center
Providence, Rhode Island, 02904
Discovery House Comprehensive Treatment Center
Providence, Rhode Island, 02905
VICTA
Providence, Rhode Island, 02907
CODAC Providence
Providence, Rhode Island, 02909
West Ridge Center
Rutland, Vermont, 05701
Spectrum Health Systems Southbridge
Southbridge, Massachusetts, 01550
Liberation Programs Stamford
Stamford, Connecticut, 06901
Habit Opco Taunton Comprehensive Treatment Center
Taunton, Massachusetts, 02780
Spectrum Health Systems Waltham
Waltham, Massachusetts, 02451
Habit Opco West Lebanon Comprehensive Treatment Center
West Lebanon, New Hampshire, 03784
Spectrum Health Systems Weymouth
Weymouth, Massachusetts, 02190
Woonsocket Comprehensive Treatment Center
Woonsocket, Rhode Island, 02895
Spectrum Health Systems Worcester
Worcester, Massachusetts, 01605
About this study
Official title: Implementing Contingency Management in Opioid Treatment Centers Across New England: A Type 3 Hybrid Trial
There is an urgent need for effective treatments for patients with opioid use disorder (OUD). This study will train opioid treatment programs in an evidence-based behavioral treatment called contingency management (CM). Contingency management (i.e., motivational incentives for achieving pre-defined treatment goals) is one of the only behavioral interventions shown to improve patient treatment outcomes when combined with FDA-approved pharmacotherapy. Unfortunately, however, uptake of CM in opioid treatment programs remains low. In response to the urgent need for evidence-based behavioral OUD treatments, the investigators propose a large-scale type 3 hybrid trial comparing two comprehensive strategies to promote CM implementation as an adjunct to pharmacotherapy within opioid treatment programs. The control condition is the staff training strategy used by the New England Addiction Technology Transfer Center, which consists of didactic workshop, performance feedback, and staff coaching. The experimental condition is the ATTC strategy enhanced by external leadership coaching (using a model called Implementation Sustainment Facilitation; ISF) and provider incentives (using a model called Pay for Performance; P4P).
A cluster randomized design trial will be conducted with 30 opioid treatment programs across New England. Centers will be randomized to one of the two implementation conditions (ATTC vs. enhanced-ATTC) over the 5 year project. At each opioid treatment program, data will be collected at multiple intervals from CM treatment providers, organizational leaders, and newly admitted patients. Additionally, patient charts will be randomly selected for review to examine sustainment. Data collection will include electronic medical record review, ratings of audio recordings by staff blind to condition, well-validated measures, and provider weekly report of patient encounter data. Specific Aims of the study are to experimentally compare the effect of the two conditions on implementation outcomes (Primary Aim) and on patient outcomes (Secondary Aim). An Exploratory Aim is to test whether two organization-level variables (i.e., implementation climate, leadership engagement) partially mediate the relationship between implementation condition and the key study outcomes.
Read the detailed description
Overdoses and deaths due to opioid use disorders (OUDs) have been declared a public health emergency in the United States, bringing to light an urgent need for highly effective OUD treatments. There are currently five FDA-approved medication formulations, which relative to placebo have demonstrated effectiveness in helping patients attain abstinence from opioids. Nonetheless, patients' opioid abstinence rates are sub-optimal: even when treated with the newest extended-release formulations only about 40% of patients maintain abstinence during the first 6-months of treatment. Contingency management (CM; i.e., motivational incentives for achieving pre-defined treatment goals) is one of the only behavioral interventions shown to improve patient abstinence from opioids when combined with FDA-approved pharmacotherapy. Unfortunately, however, uptake of CM in opioid treatment programs remains low.
The primary purpose of this study is to experimentally evaluate two different comprehensive training models to train opioid treatment programs in CM. A Type 3 Hybrid Trial will be conducted collecting data on both implementation and patient outcomes. Using a cluster randomized design, 30 opioid treatment programs across New England will be randomized to one of two comprehensive training conditions over a 5 year period. The control condition is the staff training strategy used by the Substance Abuse and Mental Health Services Administration (SAMHSA)-funded network of Addiction Technology Transfer Centers (ATTC; i.e., didactic workshop + performance feedback + staff coaching). The experimental condition is the ATTC strategy enhanced by external leadership coaching (using a model called Implementation Sustainment Facilitation [ISF], i.e., leadership coaching focused on sustainment planning) and provider incentives (using a model called Pay for Performance [P4P]; i.e., monetary bonuses for achieving pre-defined implementation goals), hereafter referred to as E-ATTC. Elements of the E-ATTC condition were informed by our team's prior NIH-funded work evaluating organization-level implementation strategies. At each OUD treatment center, data will be collected at multiple intervals from up to 2-5 CM treatment providers (n=60-150 providers), 1-2 organizational leaders (n=30-60 leaders), and 25 newly admitted patients (n=750 patients). Additionally, 25 patient charts per center (n=750 charts) will be randomly selected for review to examine sustainment. Data collection will include electronic medical record review, ratings of audio recordings by staff blind to condition, well-validated measures, and biological verification of abstinence.
The Primary Aim of the study is to experimentally compare the effect of the two training strategies on implementation outcomes. Focal implementation outcomes include: CM Exposure (provider-level measure of the proportion of providers delivering the target number of CM sessions to at least one patient during 9-month Implementation phase), CM Competence (provider-level measure of CM quality during month Implementation phase), and CM Sustainment (organization-level measure of the proportion of programs continuing to deliver CM sessions during 6-month Sustainment phase).
The Secondary Aim of the study is to experimentally compare the effect of the two training strategies on patient outcomes. Focal patient outcomes include abstinence from opioids and opioid-related problems.
An Exploratory Aim is to test whether two provider-level variables (i.e., implementation climate, leadership engagement) partially mediate the relationship between implementation condition and the key study outcomes.
Pursuit of these aims is significant given the potential to improve the treatment of OUDs in community settings, which is one of the greatest public health challenges currently facing our nation. Major strengths of the approach include the study's experimental design (cluster randomized trial), novel implementation strategy based on mixed-methods pilot data by the investigative team, large sample of organizations (N = 30), partnership with a SAMHSA-funded national training center, and rigorously measured implementation and patient outcomes.
- Conditions
- Opioid-use Disorder
- Being tested
- Addiction Technology Transfer Center (ATTC) Training Strategy, Enhanced Addiction Technology Transfer Center (E-ATTC) Training Strategy
- Keywords
- implementation, opioid use
- 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.
Addiction Technology Transfer Center (ATTC) Training StrategyBehavioural
Also called ATTC
Participating organizations will receive training consisting of 3 components: 1) didactic workshop - full-day workshop led by a contingency management (CM) expert for both CM staff and leaders, 2) performance feedback - submission of CM session recordings for review and performance feedback at least monthly for 9 months for CM staff, and 3) staff coaching - monthly provider coaching calls led by a CM expert for 9 months for both CM staff and leaders.
Enhanced Addiction Technology Transfer Center (E-ATTC) Training StrategyBehavioural
Also called E-ATTC
Participating organizations will receive all of the elements of the ATTC control condition. In addition, organizations will receive two additional elements: 1) Implementation Sustainment Facilitation - monthly coaching calls for CM leaders and staff focused on sustainment, 2) Pay for Performance - participating CM staff will have the opportunity to earn monthly monetary bonuses for achieving pre-defined implementation goals for 9 months.
| Study group | Role | What they receive |
|---|---|---|
| Addiction Technology Transfer Center (ATTC) Training | Active comparator | Half of the opioid treatment centers will receive the ATTC training strategy. Receives: Behavioral: Addiction Technology Transfer Center (ATTC) Training Strategy |
| Enhanced ATTC (E-ATTC) Training Strategy | Experimental | Half of the opioid treatment centers will receive the E-ATTC training strategy. Receives: Behavioral: Enhanced Addiction Technology Transfer Center (E-ATTC) Training Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
CM Exposure (Implementation Outcome)
Provider-level measure of whether the provider delivered the target number of CM sessions (at least 10 sessions) to at least one patient based on based on electronic medical record review and data entered into a study-specific CM tracker tool for up to 25 charts per site (25 charts*30 sites = 750 charts). Providers will report on patient encounters in the electronic medical record and the study-specific CM tracker tool, and for each encounter will report if CM was provided. Using patient level data, providers will be classified as 1 (delivered 10 or more sessions to at least 1 patient) or 0 (did not deliver 10 or more CM sessions to any patients).
*This measure was initially defined as a patient-level outcome. We altered the level at which CM Exposure was assessed because our initial approach excluded providers who were trained but never delivered CM. To follow intent-to-treat principles, we aggregate CM Exposure data at the provider-level in a manner that uses all available data.
Measured: From baseline to 9 months post-baseline
Contingency Management Competence Scale for Reinforcing Attendance (Implementation Outcome)
Provider scores on the Contingency Management Competence Scale for Reinforcing Attendance (CMCS; Petry \& Ledgerwood, 2010). Coders blind to treatment condition rate audio recorded CM sessions using the CMCS, which measures provider skill in CM delivery. CMCS contains 6 CM-specific skill items and 3 general skill items that are scored on a scale from 0 to 7. For each item, a score of 0 indicates an audio recording was not submitted, a score of 1 indicates the lowest possible skill and a score of 7 indicates the highest possible skill. Possible scale scores range from a minimum of 0 to 63. An average score will be calculated for each provider, with a minimum of 0 and maximum of 7. Providers will submit one audio recording per month for the duration of the 9-month Implementation phase. Each provider's highest CMCS score will be used in analysis. Higher scores indicate higher skill, which is a better outcome.
Measured: From baseline to 9 months post-baseline
CM Sustainment (Implementation Outcome)
Proportion of programs delivering any CM after removal of active support. This is calculated based on review of all patient charts over a 6-month interval. Providers report on patient encounters in the medical record, and for each encounter report if CM was provided. Programs are classified as 1 (reported delivering CM to at least 1 patient) or 0 (did not deliver CM to any patients). The proportion of programs delivering CM is then calculated; a higher proportion is a better outcome.
*The level at which CM Sustainment was assessed was altered from provider-level to program-level because of the frequency of programs failing to report applying CM among any patients, across any of its providers. In addition, there was such high staff turnover we could not assess at the provider-level using original provider IDs. To be able to use all available data from all programs' medical records, we report on the proportion of any programs delivering CM after removal of active support.
Measured: 6-month time interval following Implementation time period
Secondary outcomes (2)
Opioid Abstinence: Past Month (Patient Outcome)
Days of abstinence as reported using calendar-based recall based on the Timeline Followback Interview method (Sobell \& Sobell, 1992). Days of opioid abstinence will be calculated from 0 to 30 for each patient, with higher numbers indicating more days of abstinence (which is a better outcome). This will be calculated for all patients who complete follow-up.
Measured: Assessed at 3 and 6-months from patient baseline assessment
Global Appraisal of Individual Needs Opioid-Related Problem Scale: Past Month (Patient Outcome)
Count of problems as reported using an adapted version of the Global Appraisal of Needs Substance Problems Scale (Dennis et al., 2002), which has been adapted to focus specifically on problems related to opioids. The scale contains 16 items that correspond to problems related to opioid use. Patients are asked the last time they had each problem with responses including past month, past year, lifetime, or never. A count of problems experienced over the past month will be calculated for each patient. The minimum possible score is 0 and the maximum possible score is 16. Higher scores indicate higher problems, which is a worse outcome. This will be calculated for all patients who complete follow-up.
Measured: Assessed at 3 and 6-months from patient baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start9 Apr 2019
- Primary completion31 Aug 2023
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)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 Brown 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster Randomized Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 780 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- RTI International, University of Washington, UConn Health, National Institute on Drug Abuse (NIDA), Northwestern University, Ohio State University
- Responsible party
- Sponsor
- Investigators
- Sara J Becker, Ph.D., Principal investigator, Brown University and Northwestern UniversityBryan R Garner, Ph.D., Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931174
- Sponsor's protocol ID
- #1811002260
- Other IDs
- R01DA046941
- Acronym
- MIMIC
- Status last verified
- Mar 2025
- First submitted
- 23 Apr 2019
- Last updated
- 19 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and statistical analysis plan for the primary outcomes has been published in Addiction Science and Clinical Practice. Additional data (analytic code, participant-level data) can be requested from the Multiple Principal Investigators. Analysis files will be constructed from the stored 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, fax numbers, email addresses, social security numbers, medical records, etc. will be retained.
Publications
Becker SJ, Janssen T, Murphy CM, Scott K, DiClemente-Bosco K, Souza T, Garner BR. Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics): preparation phase outcomes of a hybrid type 3 trial. Implement Sci Commun. 2025 Dec 15;7(1):9. doi: 10.1186/s43058-025-00841-7.
PubMed 41398966Becker SJ, Janssen T, Souza T, Hartzler B, Rash CJ, DiClemente-Bosco K, Garner BR. Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics): results of a 28-site cluster-randomized type 3 hybrid trial. Implement Sci. 2025 Dec 9;21(1):9. doi: 10.1186/s13012-025-01473-0.
PubMed 41361474Frohe T, Janssen T, Garner BR, Becker SJ. Examining changes in pain interference via pandemic-induced isolation among patients receiving medication for opioid use disorder: a secondary data analysis. BMC Public Health. 2024 Sep 27;24(1):2581. doi: 10.1186/s12889-024-20077-9.
PubMed 39334184Janssen T, Garner BR, Yermash J, Yap KR, Becker SJ. Early COVID-Related pandemic impacts and subsequent opioid outcomes among persons receiving medication for opioid use disorder: a secondary data analysis of a Type-3 hybrid trial. Addict Sci Clin Pract. 2023 Sep 13;18(1):54. doi: 10.1186/s13722-023-00409-7.
PubMed 37705105Becker SJ, Murphy CM, Hartzler B, Rash CJ, Janssen T, Roosa M, Madden LM, Garner BR. Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics): A cluster-randomized type 3 hybrid effectiveness-implementation trial. Addict Sci Clin Pract. 2021 Oct 12;16(1):61. doi: 10.1186/s13722-021-00268-0.
PubMed 34635178
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Contingency Management in Opioid Treatment Centers Across New England: A Type 3 Hybrid Trial
- ClinicalTrials.gov ID
- NCT03931174
- Acronym / sponsor ID
- MIMIC / #1811002260
- Conditions
- Opioid-use Disorder
- Keywords
- implementation, opioid use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 780 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- RTI International, University of Washington, UConn Health, National Institute on Drug Abuse (NIDA), Northwestern University, Ohio State University
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 30 Apr 2019 (actual)
- Results
- Posted 19 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is an urgent need for effective treatments for patients with opioid use disorder (OUD). This study will train opioid treatment programs in an evidence-based behavioral treatment called contingency management (CM). Contingency management (i.e., motivational incentives for achieving pre-defined treatment goals) is one of the only behavioral interventions shown to improve patient treatment outcomes when combined with FDA-approved pharmacotherapy. Unfortunately, however, uptake of CM in opioid treatment programs remains low. In response to the urgent need for evidence-based behavioral OUD treatments, the investigators propose a large-scale type 3 hybrid trial comparing two comprehensive strategies to promote CM implementation as an adjunct to pharmacotherapy within opioid treatment programs. The control condition is the staff training strategy used by the New England Addiction Technology Transfer Center, which consists of didactic workshop, performance feedback, and staff coaching. The experimental condition is the ATTC strategy enhanced by external leadership coaching (using a model called Implementation Sustainment Facilitation; ISF) and provider incentives (using a model called Pay for Performance; P4P).
A cluster randomized design trial will be conducted with 30 opioid treatment programs across New England. Centers will be randomized to one of the two implementation conditions (ATTC vs. enhanced-ATTC) over the 5 year project. At each opioid treatment program, data will be collected at multiple intervals from CM treatment providers, organizational leaders, and newly admitted patients. Additionally, patient charts will be randomly selected for review to examine sustainment. Data collection will include electronic medical record review, ratings of audio recordings by staff blind to condition, well-validated measures, and provider weekly report of patient encounter data. Specific Aims of the study are to experimentally compare the effect of the two conditions on implementation outcomes (Primary Aim) and on patient outcomes (Secondary Aim). An Exploratory Aim is to test whether two organization-level variables (i.e., implementation climate, leadership engagement) partially mediate the relationship between implementation condition and the key study outcomes.
Detailed description
Overdoses and deaths due to opioid use disorders (OUDs) have been declared a public health emergency in the United States, bringing to light an urgent need for highly effective OUD treatments. There are currently five FDA-approved medication formulations, which relative to placebo have demonstrated effectiveness in helping patients attain abstinence from opioids. Nonetheless, patients' opioid abstinence rates are sub-optimal: even when treated with the newest extended-release formulations only about 40% of patients maintain abstinence during the first 6-months of treatment. Contingency management (CM; i.e., motivational incentives for achieving pre-defined treatment goals) is one of the only behavioral interventions shown to improve patient abstinence from opioids when combined with FDA-approved pharmacotherapy. Unfortunately, however, uptake of CM in opioid treatment programs remains low.
The primary purpose of this study is to experimentally evaluate two different comprehensive training models to train opioid treatment programs in CM. A Type 3 Hybrid Trial will be conducted collecting data on both implementation and patient outcomes. Using a cluster randomized design, 30 opioid treatment programs across New England will be randomized to one of two comprehensive training conditions over a 5 year period. The control condition is the staff training strategy used by the Substance Abuse and Mental Health Services Administration (SAMHSA)-funded network of Addiction Technology Transfer Centers (ATTC; i.e., didactic workshop + performance feedback + staff coaching). The experimental condition is the ATTC strategy enhanced by external leadership coaching (using a model called Implementation Sustainment Facilitation [ISF], i.e., leadership coaching focused on sustainment planning) and provider incentives (using a model called Pay for Performance [P4P]; i.e., monetary bonuses for achieving pre-defined implementation goals), hereafter referred to as E-ATTC. Elements of the E-ATTC condition were informed by our team's prior NIH-funded work evaluating organization-level implementation strategies. At each OUD treatment center, data will be collected at multiple intervals from up to 2-5 CM treatment providers (n=60-150 providers), 1-2 organizational leaders (n=30-60 leaders), and 25 newly admitted patients (n=750 patients). Additionally, 25 patient charts per center (n=750 charts) will be randomly selected for review to examine sustainment. Data collection will include electronic medical record review, ratings of audio recordings by staff blind to condition, well-validated measures, and biological verification of abstinence.
The Primary Aim of the study is to experimentally compare the effect of the two training strategies on implementation outcomes. Focal implementation outcomes include: CM Exposure (provider-level measure of the proportion of providers delivering the target number of CM sessions to at least one patient during 9-month Implementation phase), CM Competence (provider-level measure of CM quality during month Implementation phase), and CM Sustainment (organization-level measure of the proportion of programs continuing to deliver CM sessions during 6-month Sustainment phase).
The Secondary Aim of the study is to experimentally compare the effect of the two training strategies on patient outcomes. Focal patient outcomes include abstinence from opioids and opioid-related problems.
An Exploratory Aim is to test whether two provider-level variables (i.e., implementation climate, leadership engagement) partially mediate the relationship between implementation condition and the key study outcomes.
Pursuit of these aims is significant given the potential to improve the treatment of OUDs in community settings, which is one of the greatest public health challenges currently facing our nation. Major strengths of the approach include the study's experimental design (cluster randomized trial), novel implementation strategy based on mixed-methods pilot data by the investigative team, large sample of organizations (N = 30), partnership with a SAMHSA-funded national training center, and rigorously measured implementation and patient outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster Randomized Trial
| Arm | Type | Receives |
|---|---|---|
| Addiction Technology Transfer Center (ATTC) Training | Active comparator | Behavioral: Addiction Technology Transfer Center (ATTC) Training StrategyHalf of the opioid treatment centers will receive the ATTC training strategy. |
| Enhanced ATTC (E-ATTC) Training Strategy | Experimental | Behavioral: Enhanced Addiction Technology Transfer Center (E-ATTC) Training StrategyHalf of the opioid treatment centers will receive the E-ATTC training strategy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patients
- newly admitted to the opioid treatment center within the past 30 days
- prescribed any FDA-approved OUD medication
Key exclusion criteria (11 listed)
- None
- has been involved in providing psychosocial support to OUD patients on pharmacotherapy
- has an active caseload
- is willing to commit to 14 months of CM training and support
- None
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 |
|---|---|---|
| Addiction Technology Transfer Center (ATTC) Training StrategyAlso: ATTCParticipating organizations will receive training consisting of 3 components: 1) didactic workshop - full-day workshop led by a contingency management (CM) expert for both CM staff and leaders, 2) performance feedback - submission of CM session recordings for review and performance feedback at least monthly for 9 months for CM staff, and 3) staff coaching - monthly provider coaching calls led by a CM expert for 9 months for both CM staff and leaders. | Behavioural | Addiction Technology Transfer Center (ATTC) Training |
| Enhanced Addiction Technology Transfer Center (E-ATTC) Training StrategyAlso: E-ATTCParticipating organizations will receive all of the elements of the ATTC control condition. In addition, organizations will receive two additional elements: 1) Implementation Sustainment Facilitation - monthly coaching calls for CM leaders and staff focused on sustainment, 2) Pay for Performance - participating CM staff will have the opportunity to earn monthly monetary bonuses for achieving pre-defined implementation goals for 9 months. | Behavioural | Enhanced ATTC (E-ATTC) Training Strategy |
Primary outcome
CM Exposure (Implementation Outcome)
Time frame: From baseline to 9 months post-baseline
Provider-level measure of whether the provider delivered the target number of CM sessions (at least 10 sessions) to at least one patient based on based on electronic medical record review and data entered into a study-specific CM tracker tool for up to 25 charts per site (25 charts*30 sites = 750 charts). Providers will report on patient encounters in the electronic medical record and the study-specific CM tracker tool, and for each encounter will report if CM was provided. Using patient level data, providers will be classified as 1 (delivered 10 or more sessions to at least 1 patient) or 0 (did not deliver 10 or more CM sessions to any patients). *This measure was initially defined as a patient-level outcome. We altered the level at which CM Exposure was assessed because our initial approach excluded providers who were trained but never delivered CM. To follow intent-to-treat principles, we aggregate CM Exposure data at the provider-level in a manner that uses all available data.
Contingency Management Competence Scale for Reinforcing Attendance (Implementation Outcome)
Time frame: From baseline to 9 months post-baseline
Provider scores on the Contingency Management Competence Scale for Reinforcing Attendance (CMCS; Petry \& Ledgerwood, 2010). Coders blind to treatment condition rate audio recorded CM sessions using the CMCS, which measures provider skill in CM delivery. CMCS contains 6 CM-specific skill items and 3 general skill items that are scored on a scale from 0 to 7. For each item, a score of 0 indicates an audio recording was not submitted, a score of 1 indicates the lowest possible skill and a score of 7 indicates the highest possible skill. Possible scale scores range from a minimum of 0 to 63. An average score will be calculated for each provider, with a minimum of 0 and maximum of 7. Providers will submit one audio recording per month for the duration of the 9-month Implementation phase. Each provider's highest CMCS score will be used in analysis. Higher scores indicate higher skill, which is a better outcome.
CM Sustainment (Implementation Outcome)
Time frame: 6-month time interval following Implementation time period
Proportion of programs delivering any CM after removal of active support. This is calculated based on review of all patient charts over a 6-month interval. Providers report on patient encounters in the medical record, and for each encounter report if CM was provided. Programs are classified as 1 (reported delivering CM to at least 1 patient) or 0 (did not deliver CM to any patients). The proportion of programs delivering CM is then calculated; a higher proportion is a better outcome. *The level at which CM Sustainment was assessed was altered from provider-level to program-level because of the frequency of programs failing to report applying CM among any patients, across any of its providers. In addition, there was such high staff turnover we could not assess at the provider-level using original provider IDs. To be able to use all available data from all programs' medical records, we report on the proportion of any programs delivering CM after removal of active support.
2 secondary outcomes
Opioid Abstinence: Past Month (Patient Outcome)
Time frame: Assessed at 3 and 6-months from patient baseline assessment
Global Appraisal of Individual Needs Opioid-Related Problem Scale: Past Month (Patient Outcome)
Time frame: Assessed at 3 and 6-months from patient baseline assessment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41398966Becker SJ, Janssen T, Murphy CM, Scott K, DiClemente-Bosco K, Souza T, Garner BR. Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics): preparation phase outcomes of a hybrid type 3 trial. Implement Sci Commun. 2025 Dec 15;7(1):9. doi: 10.1186/s43058-025-00841-7.
- Derived from this study: PubMed 41361474Becker SJ, Janssen T, Souza T, Hartzler B, Rash CJ, DiClemente-Bosco K, Garner BR. Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics): results of a 28-site cluster-randomized type 3 hybrid trial. Implement Sci. 2025 Dec 9;21(1):9. doi: 10.1186/s13012-025-01473-0.
- Derived from this study: PubMed 39334184Frohe T, Janssen T, Garner BR, Becker SJ. Examining changes in pain interference via pandemic-induced isolation among patients receiving medication for opioid use disorder: a secondary data analysis. BMC Public Health. 2024 Sep 27;24(1):2581. doi: 10.1186/s12889-024-20077-9.
- Derived from this study: PubMed 37705105Janssen T, Garner BR, Yermash J, Yap KR, Becker SJ. Early COVID-Related pandemic impacts and subsequent opioid outcomes among persons receiving medication for opioid use disorder: a secondary data analysis of a Type-3 hybrid trial. Addict Sci Clin Pract. 2023 Sep 13;18(1):54. doi: 10.1186/s13722-023-00409-7.
- Derived from this study: PubMed 34635178Becker SJ, Murphy CM, Hartzler B, Rash CJ, Janssen T, Roosa M, Madden LM, Garner BR. Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics): A cluster-randomized type 3 hybrid effectiveness-implementation trial. Addict Sci Clin Pract. 2021 Oct 12;16(1):61. doi: 10.1186/s13722-021-00268-0.
- Individual participant dataSharing planned: Yes. Study protocol and statistical analysis plan for the primary outcomes has been published in Addiction Science and Clinical Practice. Additional data (analytic code, participant-level data) can be requested from the Multiple Principal Investigators. Analysis files will be constructed from the stored 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, fax numbers, email addresses, social security numbers, medical records, etc. will be retained.
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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.
Sara J Becker, Ph.D. principal investigator
Brown University and Northwestern University
Bryan R Garner, Ph.D. principal investigator
Ohio State University
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Addiction Technology Transfer Center (ATTC) Training Strategy and Enhanced Addiction Technology Transfer Center (E-ATTC) Training Strategy in people with Opioid-use Disorder, run by Brown University at 29 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 3 inclusion and 11 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 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 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?
Yes. Results are posted in the registry (first posted 19 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
CM Exposure (Implementation Outcome) (time frame: From baseline to 9 months post-baseline). 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 NCT03931174, which also lists 5 linked publications.
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 19 Mar 2025.