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Addressing Opioid Use Disorder with an External Multimodal Neuromodulation Device: Development and Clinical Evaluation of DuoTherm for Opioid-Sparing in Acute and Chronic Low Back Pain.

Award Number: R44DA049631
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: 03/31/2023

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Addressing Opioid Use Disorder with an External Multimodal Neuromodulation Device: Development and Clinical Evaluation of DuoTherm for Opioid-Sparing in Acute and Chronic Low Back Pain. - Project Summary The goal of this project is to develop a multimodal neuromodulatory opioid-sparing device for low back pain, demonstrate effective pain relief, then evaluate opioid reduction for patients with acute or chronic back pain presenting for treatment. Pain and opioid use disorder (OUD) are intricately related: dependence begins for up to 80% with medications prescribed for pain, either directly or through pills left in circulation. Currently, there is no proven approach to help reduce long-term opioid use for patients with chronic non-cancer pain. What is known is that prescriptions of opioids for acute low back pain are a factor in eventual OUD, and unused opioids in circulation are increasingly abused for non-medical reasons. For the already dependent with chronic pain, one barrier to reduction is fear of ongoing or increasing pain. An effective non-pharmaceutical pain reliever could reduce home opioid prescriptions for acute pain, and aid chronic pain patients seeking to wean. Acute and chronic low back pain are among the most common sources of short and long term disability. Opioids are commonly prescribed, but no better than non- addictive solutions for chronic low back pain. Neuromodulation (cold, high frequency vibration, low frequency whole body vibration, acupressure), heat, and support are effective for many, but no current device combines these multiple modalities of pain relief. One recent study found a surgically placed neuromodulatory device significantly decreased opioid use for patients with chronic low back pain. Low back pain would be the most impactful clinical scenario in which to test an external multi-modal neuromodulatory pain reliever for its impact on initial and chronic opioid use. Patients with chronic pain report benefitting from multiple pain relief strategies over time. Because having options improves the perception of control, the ideal pain relief device would incorporate multiple pain relieving modalities to reduce catastrophizing. To relieve sharp pain, we created an NICHD-funded “Buzzy” neuromodulatory device combining high frequency vibration and ice, now proven effective in over 28 independent clinical trials. To address low back pain, our “DuoTherm” device incorporates the Buzzy frequency, cold, heat, acupressure, and two additional frequencies. Preliminary data from 32 subjects demonstrated substantial and sustained pain reduction, distinct preferences for vibration frequencies, and strong commercial desire for the product. This project will develop and clinically evaluate DuoTherm, an innovative opioid-sparing therapeutic. This patient-controlled external neuromodulation device will be designed to address acute and chronic LBP. After validating effective pain relief with DuoTherm compared to placebo, we will test whether an effective low back pain relief device reduces opioid use for acute and chronic low back pain 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	2021	MMJ LABS LLC	195 ARIZONA AVE NE	ATLANTA	GA	30307	FULTON	USA	Drug Use and Addiction Research Programs	000	3	3/18/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $89,400 )
2023	2023	MMJ LABS, LLC	195 ARIZONA AVE LW08	ATLANTA	GA	30307	FULTON	USA	Drug Use and Addiction Research Programs	000	3	2/14/2023	SUPPLEMENT FOR EXPANSION	$89,400
														Subtotal = $89,400

Issue Date FY: 2021 ( Subtotal = $688,522 )
2021	2021	MMJ LABS, LLC	195 ARIZONA AVE LW08	ATLANTA	GA	30307	FULTON	USA	Drug Use and Addiction Research Programs	000	3	3/17/2021	NON-COMPETING CONTINUATION	$688,522
														Subtotal = $688,522

Issue Date FY: 2020 ( Subtotal = $811,478 )
2020	2020	MMJ LABS, LLC	195 ARIZONA AVE LW08	ATLANTA	GA	30307	FULTON	USA	Drug Use and Addiction Research Programs	001	2	3/31/2020	EXTENSION WITH OR WITHOUT FUNDS	$811,478
2020	2019	MMJ LABS, LLC	195 ARIZONA AVE LW08	ATLANTA	GA	30307	FULTON	USA	Drug Use and Addiction Research Programs	000	1	1/17/2020	NEW	$0
2020	2019	MMJ LABS, LLC	195 ARIZONA AVE LW08	ATLANTA	GA	30307	FULTON	USA	Drug Use and Addiction Research Programs	002	1	8/24/2020	NEW	$0
														Subtotal = $811,478

Issue Date FY: 2019 ( Subtotal = $221,959 )
2019	2019	MMJ LABS, LLC	195 ARIZONA AVE LW08	ATLANTA	GA	30307	FULTON	USA	Drug Use and Addiction Research Programs	000	1	9/18/2019	NEW	$221,959
2019	2019	MMJ LABS, LLC	195 ARIZONA AVE LW08	ATLANTA	GA	30307	FULTON	USA	Drug Use and Addiction Research Programs	001	1	9/27/2019	NEW	$0
														Subtotal = $221,959

Grand Total All Awards = $1,811,359

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Addressing Opioid Use Disorder with an External Multimodal Neuromodulation Device: Development and Clinical Evaluation of DuoTherm for Opioid-Sparing in Acute and Chronic Low Back Pain.

Award Number: R44DA049631

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: 03/31/2023

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