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Modular Virtual Reality Therapeutic for Opioid and Stimulant Use Disorders

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44DA059475-01
Agency Tracking Number: R44DA059475
Amount: $318,358.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NIDA
Solicitation Number: DA23-021
Timeline
Solicitation Year: 2023
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-09-30
Award End Date (Contract End Date): 2024-08-31
Small Business Information
2363 CEDAR KEY DR.
Lake Orion, MI 48360
United States
DUNS: 031313862
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 PAUL ZIEMBA
 (248) 762-9711
 paul.ziemba@innatevr.com
Business Contact
 PAUL ZIEMBA
Phone: (248) 762-9711
Email: paul.ziemba@innatevr.com
Research Institution
N/A
Abstract

PROJECT SUMMARY
Opioid and/or Stimulant Use Disorders (OUD/StUD) are chronic, recurring conditions that if left untreated, pose
a significant and ongoing public health and safety threat, with costs associated with OUD alone in the US
exceeding one trillion dollars annually. Virtual Reality Cue Exposure (VRCE) employs safe and controlled
repeated exposure to a variety of substance use cues and environments designed to induce craving within the
virtual space. This can be done in a way that is not feasible “in vivo” due to health and safety concerns, filling a
persistent gap in current treatment approaches for the non-pharmacological treatment of OUD/StUD. While in
the virtual environment, the patient will habituate to the substance use cues and work with a therapist to learn
coping skills for tolerating craving while not ingesting substances, weakening the conditioned association
between substance use cues and actual substance use. The HelixVR digital therapeutic is a modular VRCE
based software that allows for simulations to be tailored to each patient and is designed for use as an
adjunctive treatment for OUD/StUD under the supervision of a licensed master’s level behavioral health
provider.
Phase I work to be completed will include refinement of the user interface and increasing the number of
features offered within the software. In Phase I we will conduct a pilot effectiveness study to investigate the
impact of HelixVR on substance craving, substance use and overall quality of life. Participants (n = 50) will be
randomized to receive 4 sessions of HelixVR or another active VR based intervention at an outpatient substance
use treatment organization. Our Phase I hypothesis is that the addition of the fully immersive and tailored
HelixVR intervention into routine treatment will be associated with increased treatment completion, decreased
substance craving and decreased substance use relative to a non-tailored less immersive VR intervention.
This work will be followed by a Phase II study to expand the number of cues and environments available while
conducting a muti-site RCT (n = 200) to further evaluate the effectiveness of HelixVR. Our Phase II hypothesis
is that the use of the HelixVR digital therapeutic will result in decreased craving and substance use, as well as
decreased return to use, emergency healthcare usage, involvement with child welfare and involvement with the
criminal justice system. We anticipate that these changes will be maintained for 12 months post treatment. We
will continuously adjust our business plan, software content and clinical workflow integration protocols based
on feedback from our target customer demographics. Our long-term goal is to offer a high impact digital
therapeutic which is easily integrated into clinicians’ normal workflow, decreasing the significant
social and public health impact of OUD/StUD.

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

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