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Principal Investigator: Nina Cooperman
Organization: RUTGERS BIOMEDICAL AND HEALTH SCIENCES
Fiscal Year: 2024
Award: $669,776
Funding agency: National Institute on Drug Abuse
PROJECT SUMMARY
The United States is experiencing an opioid use and overdose crisis. To address this crisis, programs that
provide medication for opioid use disorder (MOUD) are being expanded and enhanced. MOUD is the most
effective intervention for an OUD, and methadone treatment (MT) is the most commonly prescribed MOUD;
however, approximately half of people who begin MT discontinue within a year, and half of people retained in
MT use opioids within six months. Physical pain, emotion dysregulation, and reward processing deficits,
affecting most people on MT, could be contributing to their ongoing opioid use.
Novel behavioral interventions that address physical pain, emotion dysregulation, reward processing
deficits and opioid use among people on MOUD are needed. Mindfulness-Oriented Recovery Enhancement
(MORE) integrates training in mindfulness, reappraisal, and savoring skills into an 8-week group therapy
designed to remediate hedonic dysregulation in brain reward systems underpinning OUD. Across multiple
trials, MORE has demonstrated efficacy for reducing opioid use, craving, emotional distress, and pain in other
healthcare settings. Our R21 pilot randomized controlled trial of MORE was the first to demonstrate MORE’s
feasibility and acceptability as delivered in MT clinics, with indications of preliminary efficacy for decreasing
drug use, craving, depression, anxiety, and pain for people with OUD. Further, expedited implementation and
dissemination of effective interventions is needed. However, uptake of novel interventions may be slow in MT
because time and resources are often limited. Therefore, to best address potential implementation issues and
to optimize future MORE implementation and dissemination, in this study, we will utilize a Type 2, Hybrid
Implementation-Effectiveness study design. We will not only evaluate MORE’s effectiveness but also assess
barriers and facilitators to integrating MORE into MT and evaluate the impact of a sustainable train-the-trainer
model on provider burden, intervention fidelity and engagement, and patient outcomes. We will randomize MT
clinicians to receive training in 1) a higher intensity MORE implementation strategy consisting of a train-the-
trainer model with training in the full MORE treatment manual plus supervision and feedback or 2) a minimal
intensity implementation strategy consisting of a simple, scripted mindfulness practice (SMP) extracted from
the MORE treatment manual with minimal training, no supervision, and minimal feedback.
Specifically, we aim to: 1) using a RE-AIM (reach, effectiveness, adoption, implementation, and
maintenance) framework, examine barriers and facilitators to implementation of MORE and SMP in MT and
evaluate strategies for optimizing training, fidelity, and engagement, 2) optimize existing MORE and SMP
training and implementation toolkits, including adaptable resources that can accelerate the translation of
evidence into practice, and 3) evaluate effectiveness and treatment fidelity of a higher intensity MORE
implementation strategy versus a lower intensity SMP implementation strategy as an adjunct to MT (N=420).
Terms: <Abstinence><Acceleration><Address><Adherence><Affect><American><Anxiety><Behavior Conditioning Therapy><Behavior Modification><Behavior Therapy><Behavior Treatment><Behavioral Conditioning Therapy><Behavioral Modification><Behavioral Therapy><Behavioral Treatment><Brain><Brain Nervous System><COVID-19><CV-19><Case Study><Clinic><Clinical Trials><Communities><Conditioning Therapy><Coronavirus Infectious Disease 2019><Data><Diacetylmorphine><Diamorphine><Disparities><Disparity><Dissemination and Implementation><Dropout><Drug Prescribing><Drug Prescriptions><Drug usage><Educational Materials><Effectiveness><Encephalon><Feedback><Future><Group Therapy><Heroin><Internet><Intervention><Intervention Strategies><Manuals><Measures><Mental Depression><Methods><Modeling><Opiates><Opioid><Pain><Painful><Patient outcome><Patient-Centered Outcomes><Patient-Focused Outcomes><Patients><Personal Satisfaction><Persons><Population><Provider><QOL><Quality of life><RE-AIM><Randomized><Randomized, Controlled Trials><Reach, Effectiveness, Adoption, Implementation, and Maintenance><Recovery><Relapse><Research Design><Research Resources><Resources><Rewards><Study Type><Supervision><System><Technology><Time><Trainers Training><Training><Translations><United States><Universities><Videoconferencing><WWW><acceptability and feasibility><addiction><addictive disorder><arm><assess effectiveness><behavior intervention><behavioral intervention><care as usual><case report><coronavirus disease 2019><coronavirus disease-19><coronavirus infectious disease-19><craving><delivered remotely><depression><determine effectiveness><drug use><effective intervention><effectiveness assessment><effectiveness evaluation><effectiveness testing><effectiveness trial><effectiveness/implementation hybrid study><effectiveness/implementation study><emotion dysregulation><emotional distress><emotional dysregulation><evaluate effectiveness><evidence base><examine effectiveness><experience><facilitators to implementation><feeling distress><feeling upset><health care settings><healthcare settings><hedonic><implementation facilitators><implementation strategy><intervention design><interventional strategy><medication for opioid use disorder><medication prescription><methadone maintenance><methadone maintenance program><methadone maintenance therapy><methadone maintenance treatment><methadone treatment><mindfulness><mindfulness intervention><mindfulness-based intervention><non-medical use of prescription opiates><non-medical use of prescription opioids><nonmedical use of prescription opiates><nonmedical use of prescription opioids><novel><opiate consumption><opiate crisis><opiate drug use><opiate intake><opiate overdose><opiate related overdose><opiate use><opiate use disorder><opioid analgesic misuse><opioid consumption><opioid crisis><opioid drug overdose><opioid drug use><opioid epidemic><opioid induced overdose><opioid intake><opioid intoxication><opioid medication misuse><opioid medication overdose><opioid overdose><opioid poisoning><opioid prescription medication misuse><opioid related overdose><opioid toxicity><opioid use><opioid use disorder><patient oriented outcomes><prescribed medication><prescription opiate misuse><prescription opioid misuse><prevent><preventing><primary outcome><programs><randomisation><randomization><randomized control trial><randomly assigned><reach, efficacy, adoption, implementation, and maintenance><remediation><remote delivery><reward processing><secondary outcome><skills><strategies for implementation><study design><success><therapy design><timeline><translation><treatment as usual><treatment design><uptake><usual care><video conferencing><web><well-being><wellbeing><world wide web>