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Amelioration of opioid withdrawal-induced anxiety and craving with heterodyned whole body vibration

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41DA053083-01A1
Agency Tracking Number: R41DA053083
Amount: $319,976.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIDA
Solicitation Number: DA19-020
Solicitation Year: 2019
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-06-15
Award End Date (Contract End Date): 2022-06-14
Small Business Information
6222 W 10480 N
Highland, UT 84003-9292
United States
DUNS: 078287387
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (801) 494-7804
Business Contact
Phone: (801) 770-6960
Research Institution
PROVO, UT 84602-1231
United States

 Nonprofit College or University

Opioid use disorder (OUD) is a rising problem in the United States and around the world, with pain and stress
being major factors for initial drug seeking and relapse. The mesolimbic dopamine (DA) system originating in
the midbrain ventral tegmental area (VTA) and projecting to the nucleus accumbens (NAc) in the striatum is an
important nexus for the rewarding properties of opioids and other addictive drugs and is strongly implicated in
OUD. Only two devices are currently FDA approved to treat OUD, which has prompted NIDA to issue a parent
announcement, RFA-DA-19-020 connected with the HEAL Initiative to develop technologies to curb the opioid
epidemic. This proposal aligns with the HEAL Initiative and NIDA to further the development of a novel, non-
pharmacological, heterodyned whole body vibration (HWBV) device to treat anxiety/craving associated with
OUD. In prior studies, we have reported that activation of mechanoreceptors with mechanical stimulation of
cervical spine vertebrae at a frequency of 45-80 Hz inhibits the activity of VTA GABA neurons, enhances the
activity of DA neurons, and subsequently increases DA release in the NAc via endogenous opioids and delta
ORs (DORs) in the NAc. We show preliminary data demonstrating that whole body vibration (WBV) in rodents,
at the same frequencies that are optimal for cervical spine mechanoreceptor activation, ameliorates neuronal,
neurochemical, and behavioral effects of alcohol dependence, which is similar in scope and mechanism to
opioid dependence. Additionally, we show preliminary evidence using a novel heterodyned (HWBV) technology
consisting of two independent actuators vibrating at different frequencies that generate a low frequency
traveling wave that propagates throughout the body. We show preliminary evidence that this traveling,
interferential wave ameliorates anxiety in drug-free subjects. The objectives of this proposal are to develop a
normative database in drug-free subjects, refine parameters, telemetrics, and active vibration control of the
HWBV technology and evaluate the translational relevancy of our pre-clinical findings to treat OUD. The core
hypothesis is that HWBV will ameliorate the anxiety/craving associated with withdrawal from chronic
opioid use. We propose two Specific Aims in Phase I that involve translational studies informed by our pre-
clinical studies in rodents and humans. Aim 1 involves the continued development of a vibration targeting
HWBV device and the creation of a normative data base of optimized treatment parameters in drug-free non-
AUD subjects. Aim 2 involves the evaluation of the utility of HWBV in male and female persons with OUD at
treatment facilities in the area to ameliorate anxiety/craving as a treatment for OUD. PhotoPharmics, Inc in
collaboration with investigators at Brigham Young University, proposes systematic studies to provide continued
proof-of-principle that HWBV is effective in treating anxiety/craving associated with OUD. We plan to submit a
Phase II proposal with the objective to manufacture more systems and complete an FDA-approved, clinical
trial consisting of 100+ persons with OUD to further refine the systems towards commercialization.PROJECT NARRATIVE
The Aim of this proposal is to provide proof-of-principle that a novel technology predicated on pre-clinical
studies will ameliorate anxiety and craving associated with the opioid use and abuse. The rationale for this
proposal is predicated on the belief that non-invasive, non-pharmacological activation of peripheral
mechanoreceptors by focused mechanical stimulation modulates brain substrates dysregulated by opioid use
disorder. Our novel technology has much promise to target the brain mechanisms underlying the recreational
use and abuse potential of opioids and its development will pave the way for more effective, personalized
treatment strategies that could reverse dependence on these drugs and save lives and resources throughout
the world.

* Information listed above is at the time of submission. *

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