Document text
Principal Investigator: RISA B WEISBERG
Organization: BEHAVR, LLC
Fiscal Year: 2024
Award: $805,212
Funding agency: National Institute on Drug Abuse
Project Summary: The US is experiencing an opioid crisis, with an estimated 2.5 million Americans meeting
full criteria for opioid use disorder (OUD). Medications for opioid use disorder (MOUD) like buprenorphine are
currently the most effective form of intervention for OUD. In spite of the proven efficacy of MOUD, nearly half of
people who begin a MOUD relapse within six months. As such, novel and efficacious behavioral adjuncts to
MOUD are needed to improve treatment outcomes. Mindfulness-Oriented Recovery Enhancement (MORE), a
cognitive-affective training intervention generated through a NIDA-funded treatment development process has
shown significant promise, demonstrating therapeutic effects in four randomized controlled trials (RCTs) by
reducing opioid use and misuse and modulating neurophysiological responses during drug cue-reactivity and
natural reward processing. However, the MORE intervention requires significant human interaction and is
therefore resource intensive. Further, in light of the COVID-19 pandemic, people with OUD may be reticent to
engage in face-to-face interventions due to the risk of viral spread. To overcome these implementation barriers
and increase access to treatment, the proposed project will develop and test a virtual reality version of the
MORE intervention (MORE-VR) built on BehaVR LLC's VR existing, commercially available platform, the
Dynamic eXperience Engine (DXE). The DXE uses machine learning to integrate biometrics into the VR
experience to personalize addictions treatment, boosting patient engagement and optimizing the efficacy of
clinical intervention. In Phase I, we will develop and test the MORE-VR prototype in a single arm clinical study
of OUD patients receiving buprenorphine in an opioid treatment program (OTP), focusing on patient safety and
engagement. If the prototype is perceived to have adequate usability and Net Promoter Scores, as well as to
produce improvements in proximal measures of craving and affective state, the project will progress to Phase
II. In Phase II, we will first develop the MORE-VR Minimal Viable Program using feedback from our Phase I
study to optimize the intervention, and then conduct a RCT of MORE-VR vs. MOUD treatment as usual. Our
robust and unbiased research design will triangulate clinical outcome measurement with biochemical
verification of abstinence, ecological momentary assessments (EMA), and neurophysiological assessment of
cue-reactivity. Further, we will integrate the MORE-VR Program into the OTP operational environment, building
Fast Healthcare Interoperability Resources interfaces to ingest patient data from electronic medical records
(EMRs) and to export patient utilization, assessment, and biometric data back to EMRs to create patient
records and inform clinicians of patient progress. Activities in Phase I and Phase II will help define the
regulatory pathway and establish regulatory feasibility to precede Food and Drug Administration (FDA)
approval of the MORE-VR system as a Class II medical device. In sum, this project will translate an evidence-
based biobehavioral treatment approach into an innovative digital therapeutic for OUD.
Terms: <Abstinence><Access to Care><Adherence><Affect><Affective><American><Area Under Curve><Back><Behavior Conditioning Therapy><Behavior Modification><Behavior Therapy><Behavior Treatment><Behavioral><Behavioral Conditioning Therapy><Behavioral Modification><Behavioral Therapy><Behavioral Treatment><Biochemical><Biometrics><Biometry><Biostatistics><Brain><Brain Nervous System><Buprenorphine><COVID crisis><COVID epidemic><COVID pandemic><COVID-19 crisis><COVID-19 epidemic><COVID-19 era><COVID-19 global health crisis><COVID-19 global pandemic><COVID-19 health crisis><COVID-19 pandemic><COVID-19 period><COVID-19 public health crisis><COVID-19 years><Cell Communication and Signaling><Cell Signaling><Clinic><Clinical><Clinical Research><Clinical Study><Cloud Computing><Cloud Infrastructure><Cognitive><Computerized Medical Record><Conditioning Therapy><Data><Development><Dorsum><Dropout><Drug Modulation><Drugs><Ecological momentary assessment><Education for Intervention><Educational Intervention><Electronic Health Record><Electronic Medical Record><Encephalon><Environment><Epidemic><FHIR><Fast Healthcare Interoperability Resources><Feedback><Food and Drug Administration><Funding><Goals><Health Services Accessibility><Human><Human Resources><Individual><Ingestion><Instruction Intervention><Intervention><Intervention Strategies><Intracellular Communication and Signaling><Light><Link><Machine Learning><Manpower><Measures><Medical Device><Medication><Modern Man><NIDA><National Institute of Drug Abuse><National Institute on Drug Abuse><Opiates><Opioid><Outcome><Outcome Measure><Participant><Patients><Persons><Pharmaceutical Preparations><Phase><Phase I Study><Photoradiation><Physiologic Psychology><Physiological Psychology><Process><Protocol><Protocols documentation><Psychophysiological><Psychophysiology><Randomized, Controlled Trials><Records><Recovery><Regulatory Pathway><Relapse><Research Design><Research Resources><Resources><Rewards><Risk><SARS-CoV-2 epidemic><SARS-CoV-2 global health crisis><SARS-CoV-2 global pandemic><SARS-CoV-2 pandemic><SARS-coronavirus-2 epidemic><SARS-coronavirus-2 pandemic><SBIR><Safety><Self Efficacy><Services><Severe Acute Respiratory Syndrome CoV 2 epidemic><Severe Acute Respiratory Syndrome CoV 2 pandemic><Severe acute respiratory syndrome coronavirus 2 epidemic><Severe acute respiratory syndrome coronavirus 2 pandemic><Signal Transduction><Signal Transduction Systems><Signaling><Small Business Innovation Research><Small Business Innovation Research Grant><Specific qualifier value><Specified><Study Type><Sum><System><Techniques><Teleconferences><Testing><Therapeutic Effect><Training><Training Intervention><Translating><Treatment outcome><USFDA><United States><United States Food and Drug Administration><Viral><access to health services><access to services><access to treatment><accessibility to health services><addiction><addictive disorder><affective neuroscience><arm><availability of services><barrier to care><barrier to health care><barrier to healthcare><barrier to treatment><barriers to implementation><behavior intervention><behavioral intervention><biobehavior><biobehavioral><biological signal transduction><care access><care as usual><chronic pain><clinical efficacy><cloud based computing><cloud computer><commercialization><coronavirus disease 2019 crisis><coronavirus disease 2019 epidemic><coronavirus disease 2019 global health crisis><coronavirus disease 2019 global pandemic><coronavirus disease 2019 health crisis><coronavirus disease 2019 pandemic><coronavirus disease 2019 public health crisis><coronavirus disease crisis><coronavirus disease epidemic><coronavirus disease pandemic><coronavirus disease-19 global pandemic><coronavirus disease-19 pandemic><craving><cue reactivity><design><designing><develop therapy><developmental><digital therapeutics><digital therapy><digital treatment><drug/agent><effective intervention><efficacy study><electronic data><electronic health care record><electronic health medical record><electronic health plan record><electronic health registry><electronic medical health record><evidence base><experience><health service access><health services availability><implementation barriers><implementation challenges><improved><ingest><innovate><innovation><innovative><instructional intervention><intervention development><interventional strategy><machine based learning><measurable outcome><medication for opioid use disorder><meeting><meetings><mindfulness><neurophysiological><neurophysiology><non-medical opioid use><nonmedical opioid use><novel><obstacle to care><obstacle to healthcare><opiate consumption><opiate crisis><opiate drug use><opiate intake><opiate misuse><opiate use><opiate use disorder><opioid consumption><opioid crisis><opioid drug use><opioid epidemic><opioid intake><opioid misuse><opioid treatment program><opioid use><opioid use disorder><outcome measurement><participant engagement><patient engagement><patient safety><personnel><phase 1 study><physiopsychology><pilot test><prevent relapse><programs><promoter><promotor><prototype><psycho-physiological><randomized control trial><relapse prevention><remediation><response><reward processing><satisfaction><service availability><severe acute respiratory syndrome coronavirus 2 global health crisis><severe acute respiratory syndrome coronavirus 2 global pandemic><skills><study design><success><therapeutic agent development><therapeutic development><therapy development><treatment access><treatment as usual><treatment development><treatment program><treatment risk><treatment strategy><usability><usual care><virtual><virtual machine><virtual reality><virtual reality system>