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Opioid-Sparing pain management for Chronic Low Back Pain patients using TMC-CP01 - A VANISH (Virtual Autonomic Neuromodulation Induced Systemic Healing) based program

Award Number: R44DA049630
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/30/2019
PERIOD OF PERFORMANCE END DATE: 12/31/2024

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Opioid-Sparing pain management for Chronic Low Back Pain patients using TMC-CP01 - A VANISH (Virtual Autonomic Neuromodulation Induced Systemic Healing) based program - An estimated 100 million Americans suffer from chronic pain and low back pain is the leading type of chronic pain. In fact, low back pain (LBP) is the number one cause of disability in the world and in the U.S. this chronic disease accounts for 264 million lost work days in one year. While 31 million Americans suffer from chronic low back pain (CLBP), today the most commonly prescribed drug for low back pain remains opioids. However, opioids have been found to be ineffective for CLBP. Rather, opioids provide modest short-term pain relief that render them inadequate for patients living day to day with CLBP. Furthermore, Opioids users are subject to drug tolerance and decreasing pain management efficacy over time. A significant portion of CLBP patients are on a 50mg or more-morphine milligram equivalent (MME) daily opioid dosage. Even more than a significant increase in risk of inadvertent prescription opioid overdose, individuals on 50mg or more MME a day are more likely to experience fatality. CLBP patients need an effective, safe, and accessible form of pain management that addresses both physical symptoms of pain as well as psychological symptoms such as depression and anxiety. We will seek to provide a pain management alternative for CLBP patients who are on a greater than 50mg morphine milligram equivalent (MME) daily opioid dosage to reduce medication usage, increase pain management, and increase overall functionality. To address these issues, we will develop, utilize, and augment one novel science-enabling technology combined with validated pain management treatments: 1) virtual reality to stimulate patients’ visual, auditory, and haptic fields in effort to simultaneously distract and actively engage patients in 2) biofeedback therapy, which will allow patients to consciously self-regulate their nervous system by paring down their sympathetic tone through exercises in controlling respiration and HRV. We leverage novel technology and validated therapy for the overarching aim of this proposal: to provide CLBP patients on a 50mg or more MME daily opioid dosage with an opioid-sparing pain management tool aiming to increase pain management efficacy and decrease risk of health complications. Across both Phase I and Phase II, we will sample from a population of CLBP patients on a 50mg or more MME daily opioid dosage. In Phase I a group receiving our intervention with opioids will be compared to a group receiving just opioids. Both groups will receive the same opioid tapering guidelines and we expect the intervention group to have greater success reducing opioid usage. Our Phase II trial will test the two previous groups in addition to a third group receiving opioids and a sham virtual reality experience, similar to current distraction- based VR used for acute pain management. All three groups will receive identical opioid tapering instructions. We hypothesize patients in the intervention group will observe lower pain scores, less opioid usage, greater functionality, and improved psychological and physiological measures. Our development and research focus on maximizing pain management efficacy while providing an opioid-sparing pain management tool for CLBP patients.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	TAMADE LLC	1800 LOMA VISTA ST	PASADENA	CA	91104	LOS ANGELES	USA	Drug Use and Addiction Research Programs	000	2	9/4/2024	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $989,571 )
2022	2022	TAMADE LLC	1800 LOMA VISTA ST	PASADENA	CA	91104	LOS ANGELES	USA	Drug Use and Addiction Research Programs	000	2	12/23/2021	EXTENSION WITH OR WITHOUT FUNDS	$989,571
														Subtotal = $989,571

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2019	TAMADE LLC	1800 LOMA VISTA ST	PASADENA	CA	91104	LOS ANGELES	USA	Drug Use and Addiction Research Programs	000	1	2/4/2021	NEW	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2019	TAMADE LLC	1800 LOMA VISTA ST	PASADENA	CA	91104	LOS ANGELES	USA	Drug Use and Addiction Research Programs	000	1	1/17/2020	NEW	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $225,000 )
2019	2019	TAMADE, LLC	1800 LOMA VISTA ST	PASADENA	CA	91104	LOS ANGELES	USA	Drug Use and Addiction Research Programs	001	1	9/19/2019	NEW	$0
2019	2019	TAMADE, LLC	1800 LOMA VISTA ST	PASADENA	CA	91104	LOS ANGELES	USA	Drug Use and Addiction Research Programs	000	1	9/18/2019	NEW	$225,000
														Subtotal = $225,000

Grand Total All Awards = $1,214,571

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Opioid-Sparing pain management for Chronic Low Back Pain patients using TMC-CP01 - A VANISH (Virtual Autonomic Neuromodulation Induced Systemic Healing) based program

Award Number: R44DA049630

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/30/2019

PERIOD OF PERFORMANCE END DATE: 12/31/2024

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