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Principal Investigator: Farshad Tehrani
Organization: ACTIOX LLC
Fiscal Year: 2024
Award: $55,000
Funding agency: National Institute on Drug Abuse
Opioid overdose is a significant public health problem that has been escalating in recent years. Based on the
statistics from the Centers for Disease Control and Prevention (CDC), the number of overdose-related deaths
surpassed 100,000 from April 2020 to April 2021. This is a significant increase in overdose cases related to
natural and semi-synthetic opioids, synthetic opioids, and psychostimulants. Alarmingly, in the one-year period
leading up to April 2021, fentanyl was the top cause of death for adults between 18 and 45 years old, surpassing
fatalities caused by car accidents, suicide, COVID, and cancer. Methadone is a well-established medication that
has been used for decades to treat opioid use disorder (OUD). However, there is currently no continuous
monitoring device that can provide real-time information on methadone levels in the body. This gap in monitoring
can result in patients not receiving optimal doses of methadone, leading to relapse or overdose. To address this
problem, we propose a wearable device for continuous monitoring of methadone. Our proposed device is a
minimally invasive microneedle technology that can be worn on the skin. This device will continuously monitor
methadone levels in the body, providing real-time feedback to patients and healthcare professionals. The device
is small, discreet, and easy to use, making it ideal for use in various settings. The proposed SBIR project aims
to leverage our innovative microneedle technology to develop a wearable device that can continuously monitor
therapeutic levels of methadone in the interstitial fluid for a week. In order to achieve this, the team will perform
systematic optimization studies on the surface architecture of the sensor to enable highly sensitive, stable, and
selective methadone sensing performance. Aim 1 constitutes in-vitro feasibility studies to find the best chemical
modification strategy with high sensitivity. Aim 2 will involve extending the stability of the sensor to one week of
continuous operation. Aim 3 will assess the selectivity, reproducibility, and shelf life of the developed MN-based
methadone sensors in serum samples and involves further developments in the electronics and the
accompanying app of the device. Upon successful completion of Phase I, Phase II will focus on demonstrating
the utility and establishing reliability of the sensor via extensive clinical studies in both animals and in human
subjects. The device will not only provide accurate and personalized dosing of methadone but also help in
mitigating OUD by alerting patients and healthcare professionals when levels of methadone fall below or rise
above therapeutic levels. This will enable healthcare providers to adjust the methadone dose in real-time,
ensuring that patients receive optimal dosages to prevent relapse and overdose. The proposed wearable device
for continuous monitoring of methadone is a crucial innovation that will help to address the problem of opioid
overdose. The device will provide accurate and personalized dosing of methadone, help to mitigate OUD, and
can be used among different populations. Our proposed device has the potential to improve the quality of life of
patients, reduce healthcare costs, and ultimately save lives.
Terms: <21+ years old><Actiq><Adanon><Address><Adult><Adult Human><Althose><Animals><Architecture><Biochemical><Blood Serum><COVID-19><CV-19><Cancers><Cause of Death><Centers for Disease Control><Centers for Disease Control and Prevention><Centers for Disease Control and Prevention (U.S.)><Cessation of life><Chemicals><Clinical Research><Clinical Study><Coronavirus Infectious Disease 2019><Death><Development><Devices><Dolophine><Dose><Drugs><Duragesic><Electronics><Engineering / Architecture><Ensure><Feasibility Studies><Feedback><Fentanest><Fentanyl><Fentyl><Health Care Costs><Health Care Professional><Health Care Providers><Health Costs><Health Personnel><Health Professional><Healthcare Costs><Healthcare Providers><Healthcare professional><Healthcare worker><In Vitro><Intercellular Fluid><Interstitial Fluids><Life><Malignant Neoplasms><Malignant Tumor><Marketing><Medication><Methadone><Methadose><Modification><Monitor><Needles><Overdose><Patients><Performance><Pharmaceutical Preparations><Phase><Phentanyl><Physiology><Population><Public Health><QOL><Quality of life><Relapse><Reproducibility><Risk Reduction><SBIR><Sampling><Serum><Skin><Small Business Innovation Research><Small Business Innovation Research Grant><Suicide><Surface><Technology><Therapeutic><Time><United States Centers for Disease Control><United States Centers for Disease Control and Prevention><adulthood><automobile accident><car accident><coronavirus disease 2019><coronavirus disease-19><coronavirus infectious disease-19><design><designing><developmental><dosage><drug/agent><electronic><electronic device><falls><fatal attempt><fatal suicide><health care personnel><health care worker><health provider><health workforce><healthcare personnel><human subject><improved><individual patient><innovate><innovation><innovative><innovative technologies><intent to die><malignancy><medical personnel><minimally invasive><monitoring device><neoplasm/cancer><operation><operations><opiate overdose><opiate related overdose><opiate use disorder><opioid drug overdose><opioid induced overdose><opioid intoxication><opioid medication overdose><opioid overdose><opioid poisoning><opioid related overdose><opioid toxicity><opioid use disorder><overdose risk><precision medicine><precision-based medicine><prevent relapse><psychostimulant><reduce risk><reduce risks><reduce that risk><reduce the risk><reduce these risks><reduces risk><reduces the risk><reducing risk><reducing the risk><relapse prevention><risk-reducing><sensor><statistics><suicides><synthetic opiate><synthetic opioid><treatment provider><wearable><wearable device><wearable electronics><wearable system><wearable technology><wearable tool><wearables>