Substance Use Disorder (SUD) has reached epidemic proportions in the US; it is estimated that more than 20M people, aged 12 and over, suffer from SUD.  The resources to manage it are insufficient to meet ever-increasing demands.  It is well-recognized that individual patient treatment needs change constantly, and the outcomes of treatment are unpredictable and problematic. We, as a Society, are losing ground in our battle with opioid misuse and Substance Use Disorder (SUD).

The healthcare, economic, and societal costs of substance use/abuse (alcohol and illegal drugs) are immense.  According to the National Institute of Drug Abuse (NIDA), the annual costs for treating alcohol abuse ($185M) and illicit drug use ($161M) are comparable to those incurred for treating diabetes ($132M) and cancer ($172M).  SUD is a major contributor to morbidity/mortality of cancer, cardiovascular disease, stroke, and HIV/AIDS.  The treatment of opioid overdose in emergency departments and post-emergency hospitalization continually places a tremendous burden on strained  healthcare systems.  SUD is commonly a significant factor in automobile accidents, domestic violence, child abuse, and stress/depression. SUD disrupts families, the workplace, and Society as a whole. 

The care of SUD patients is difficult.  Elements contributing to successful management in our (Carilion Clinic) System include an effective healthcare team (emergency, in- and out-patient physicians, therapists, clinical care coordinators who provide significant case management), a high level of facilitated communication among patients, interacting healthcare providers and social support networks, drug screening, induction and monitoring of controlled medications (suboxone), and transition from inpatient to highly monitored outpatient care.  Management failures commonly are related to non-adherence and continued use of illicit or unmanaged prescription drugs, lack of consistent use of drug screens to inform the treatment path, medical complications associated with continued substance misuse (endocarditis, osteomyelitis), patient ‘lost-to-follow-up’, or incarceration (frequently with no programmatic SUD management while in the correctional facility).

The unique medical and behavioral needs of SUD patients are currently difficult (impossible?) to monitor, making dynamic adjustment of treatment and delivery a (distant?) goal, rather than a reality.  Our multidisciplinary Team of healthcare professionals, engineers, and statisticians believes that the individualized and personalized treatment of each patient – monitored and modified regularly to meet patient needs – is key to their recovery.       

Fundamentally, changes need to be made in current SUD patient management practices including:

• more intensive monitoring (at the point-of-care for opioid use and medication assisted treatment – MAT adherence),
• using a data-driven multidisciplinary approach for outcomes/efficacy assessment (at least weekly),
• development of interactive care systems (e.g., telemedicine) to facilitate and drive (enforce?) patient-patient support network-caregiver (the Team) interactions, and,
• outcomes need to be evaluated, promoted, incorporated into existing SUD programs, and patient success needs to be incentivized.

Over an 18-month period, we are proposing development and deployment of an innovative technology leading to a strategy to improve outcomes (increased successful management and patient recovery) of SUD treatment.  The key to implementing this strategy is development of a Raman spectroscopy-based point-of-care technology for detection of opioids in urine and saliva.  We already have extensively validated key elements of this technology for disease detection (e.g., chronic kidney failure, COVID19 complications) and detection of drug dilution/diversion (including suboxone and fentanyl) (see Appendices).  We now propose to develop this technology as a key component of personalized SUD management programs.

Data derived from this technology, coupled with other medical data, will be available to healthcare providers in real-time, to inform decision-making and treatment planning.  We believe this novel strategy (a “One-Stop Shop”) and development of personalized treatment plans, based on data, will:

• increase rates of medication-assisted therapy (MAT) adherence,
• facilitate compliance with abstinence/recovery group attendance,
• indicate current illicit or prescription substance use,
• enable provider MAT assessment and refill prescription/dose adjustment or medication change – based on results of this technology,
• allow real-time recognition of potential interactions/complications of MAT and other drugs (e.g., concurrent opioid and benzodiazepine use increases the risk of overdoses; opioids and stimulants such as methamphetamines increases the risk of stroke or cardiac deaths).

The proposed technology-driven system will be much more convenient (“real-time”) and cost effective (<$2/sample) for patients and the healthcare system – which will increase the probability of actually getting drug screens completed.  This time-critical information can be used to guide continued addiction treatment by providers, leading to improved outcomes and recovery opportunities (i.e., brain adaptation and behavioral change).

This project is designed to be a unique and innovative collaboration between physician-scientists at Carilion Clinic, Rametrix® Technologies, Inc., and engineers, clinicians, and statisticians at Virginia Tech.