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N/A N=186 Randomized Single-blind Health Services Research

Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics)

Opioid-use Disorder

Enrolled (actual)
186
Serious AEs
0.3%
Results posted
Mar 2025
Primary outcome: Primary: CM Exposure (Implementation Outcome) — 18; 31 Participants — p=0.097

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Addiction Technology Transfer Center (ATTC) Training Strategy (Behavioral); Enhanced Addiction Technology Transfer Center (E-ATTC) Training Strategy (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Brown University
Primary completion
Aug 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
CM Exposure (Implementation Outcome)
18; 31 0.097
PRIMARY
Contingency Management Competence Scale for Reinforcing Attendance (Implementation Outcome)
0.53; 1.25 0.02 sig
PRIMARY
CM Sustainment (Implementation Outcome)
6; 6 0.430
SECONDARY
Opioid Abstinence: Past Month (Patient Outcome)
8.89; 9.39; 10.15; 8.33 .034 sig
SECONDARY
Global Appraisal of Individual Needs Opioid-Related Problem Scale: Past Month (Patient Outcome)
2.43; 2.55; 2.24; 2.17 0.27

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). 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.

Eligibility Criteria

Inclusion criteria for community-based opioid treatment programs (n = 30):

  • prescribes FDA-approved medication to treat adult patients with OUDs
  • enrolls 5+ new patients per month
  • has at least 2 staff who provide psychosocial support to OUD patients

Exclusion criteria

  • 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

Exclusion criteria

  • None

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

Exclusion criteria

  • None

Inclusion criteria for patients (n = 750):

  • adult patients
  • newly admitted to the opioid treatment center within the past 30 days
  • prescribed any FDA-approved OUD medication

Exclusion criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03931174). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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