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Development of Portable Neuromodulatory Devices for the Treatment of Substance Use Disorders

Description:

Number of anticipated awards: 4
Budget (total costs, per award including F&A and fee):
Phase I: $225,000 for 8 months
Phase II: $1,500,000 for 1 year
Fast-Track proposals will not be accepted.
NIDA strongly suggests that proposals adhere to the above project period. NIDA may not fund proposals with budgets exceeding the above amounts and project periods.
Summary
The National Institute on Drug Abuse (NIDA) has an interest in assisting people to overcome substance use disorders (SUDs) and to achieve and maintain sustained recovery. There are effective pharmacological and behavioral treatments for some substance use disorders, however not all individuals respond to treatment and long-term success rates tend to be low. Following the approval of neuromodulatory devices for the treatment of mental health disorders such as depression, obsessive compulsive disorder and neurological disorders such as Parkinson’s disease, there is a growing interest to apply neuromodulatory technologies to SUDs. Studies that examine the effects of neuromodulation on nicotine, alcohol and cocaine use have suggested that this technology may have a significant potential for therapeutic use in SUDs. However, further work is needed to build upon these preliminary research studies that use prototypic neuromodulatory technologies. Limited data are available that describe the relationship between changes in brain circuitry and behavioral responses, the types of SUD behavioral activities responsive to neuromodulation, the number of treatments needed to establish and maintain behavioral responses, or the duration and persistence of such responses. For example, the current data suggest that for the therapeutic effects of rTMS and tDCS to have any lasting effect, repeated treatments and thus repeated clinic visits are needed. Current constraints to the therapeutic use of neuromodulatory devices lies in the size, cost, and complexity of current generation tools. The lack of portability of neuromodulatory devices and need for repeated daily clinical treatment increases patient costs and hinders the studies required to improve the development and ultimate acceptance of these modalities. In order to accelerate the portability of neuromodulatory device research, NIDA is seeking SBIR proposals to develop portable neuromodulation devices that by their flexibility of use will be able to extend the current research and provide novel tools to evaluate the use of neuromodulation for SUD treatment.

Project Goals
To build on established well-controlled, published empirical studies by developing commercially viable portable neuromodulatory devices for the treatment of SUDs. Successful awardees will develop new or convert existing neuromodulatory technologies used for other indications to treat SUDs, in a manner that will facilitate wide application and enhance market penetration. The technologies should translate peer-reviewed academic research studies using prototypic neuromodulatory technologies into FDA-approvable commercial products.
 The portable neuromodulatory devices produced should demonstrate similar efficacy to modulate brain circuitry, as
validated by neuroimaging to that of prototypic devices as reported in the literature
 The portable neuromodulatory device should be oriented towards specific SUD-related indications
 In addition to being efficacious, devices should be safe and practical given cost/benefit considerations
o Examples include transcranial magnetic stimulation, direct current stimulation, and vagal stimulation, while development of new invasive technologies (e.g., deep-brain stimulation), might be more difficult to justify in terms of risk/reward ratio and likely patient acceptability.
The Phase I contract proposal must include:
 Go/no-go decision tree with quantitative, not subjective milestones  Objective measures that examine both the delivered dosage/treatment duration and the proposed mechanisms of action of the portable neuromodulatory device. Studies should include validated empirically established
comparators.  Studies designed to address all project-specific questions of feasibility.  Detailed discussion of potential pitfalls, side effects and safety issues associated with the technology and how these
concerns are to be mitigated.  Device development plan with the appropriate regulatory authorities at the FDA and provide a regulatory pathway in the contract application.
Phase I Activities and Expected Deliverables
This phase focuses on characterizing the neuromodulatory device and parameters of the device, including:  Building a prototypic and appropriately-sized functional device; demonstrate feasibility  Ensuring the portable neuromodulatory device includes a refractory period or other suitable mechanism to safeguard
from overuse of the device.  Showing bio-equivalency based on protypic measure and demonstrate device capability, for example, by comparing
the effects using imaging or other techniques (fMRI, EEG, etc).  Complete initial safety studies  Complete a proof-of-concept clinical trial  The Contractor will design a clinical study to assess the feasibility and acceptability of the device. The study should
have a minimum of 15 enrolled participants. If desired, NIDA may provide assistance with the study design and finding clinical partners.  A milestone on the acceptability of integrating portable devices with pharmacotherapies or behavioral therapies to maximize treatment efficacy, functional and/or clinical outcomes will be required
 Following determination of milestone acceptability by NIDA, a 1-week outpatient study will be conducted. This study is to evaluate 1) measures of acceptability including retention of the portable device, 2) measures of discomfort, 3) portability, and 4) durability. This study should have a minimum of 24 enrolled participants
Phase II Activities and Expected Deliverables
Phase II involves clinical studies on the effects of the portable neuromodulatory device to the user and device usability.
NIDA is required to review the clinical protocols prior to study initiation.  Lab test of device followed by improvement finalization  A test on SUD with a minimum of 15 enrolled participants. If desired, NIDA may provide assistance with the study
design and finding clinical partners.  File an IDE, Complete IDE-enabling studies, and retesting of device in a Phase I condition  Detailed commercialization plan, including cost analysis, market strategy to extend treatment effects and reduce
relapse, device sales and reimbursement possibilities

Planned Timing of Awards
 The Phase I report will be due exactly 11 months after the date of issuance of the Phase I contract.  No extensions will be granted for Phase I.
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