Product Prototypes to Combat Drug Craving Challenge

Challenge Summary:

The National Institute on Drug Abuse (NIDA), one of the components of the National Institutes of Health (NIH), is announcing the “Product Prototypes to Combat Drug Craving” Challenge. The Challenge goal is to solicit working prototypes of multifaceted products that will help with drug craving in people who experience substance use problems or with substance use disorder (SUD). Ideally, these multifaceted product prototypes would combine several different tools or features to address drug craving, providing long-term, on-demand, and personalized comprehensive assistance that can ultimately reduce the likelihood of return to use (also known as recurrence). NIDA expects that the Challenge will inspire many different product prototypes to help people address their drug cravings and prevent recurrence of drug use.

The Challenge will offer up to two awards: up to $50,000 for first place and up to $35,000 for second place entries, as well as up to three honorable mention awards of up to $5,000 each. The Challenge total purse is up to $100,000.

Subject of the Challenge:

Substance use disorder (SUD) is a chronic disease, and like other common chronic diseases (e.g., heart disease and diabetes), SUD can be treated and managed successfully. Among the U.S. population aged 12 years and over, approximately 37 million people have engaged in illicit drug use in the past 30 days, and over 18 million people in the U.S. have a drug use disorder. As with any chronic disease, SUD patients may experience recurrence, and studies indicate that about 40-60% of individuals resume drug use after an attempt to stop and/or after receiving treatment. People with SUD who experience recurrence after a period of abstinence are at high risk for overdose due to lost tolerance; their bodies are no longer used to the same dose of the drug that they took prior to beginning abstinence. 

Drug craving raises the risk of return to use. A drug craving is a strong desire or urge for the drug. People experiencing cravings may be intensely preoccupied with the drug or how it makes them feel such that they cannot think of anything else. They may even feel that they cannot live without the substance they are craving. Drug cravings may be triggered by stress, certain moods, being in social situations that remind the individual of drug-taking, being in places where drugs were used previously, seeing images related to drug use, or being around the drug itself.

Drug craving is rooted in processes of reinforcement learning that occur with repeated drug-taking. Increased dopamine signaling in an area of the brain sometimes called the “reward circuit” builds and strengthens associations between the drug and internal and external cues; over time, dopamine is released in these circuits when the individual encounters those cues, and these releases of dopamine motivate the individual to seek and take the drug. Occasionally, this motivation overrides strong intentions to not use the drug, for instance in a person in recovery. The changes in the brain circuits that facilitate drug craving can persist long after detoxification and abstinence from the substance.

Drug cravings are typically subjective and highly individualized in terms of their intensity, frequency, and triggers, so a one-size-fits-all approach will not be appropriate for all people seeking to prevent or reduce these cravings. For example, two patients with an opioid use disorder could be shown the same image of a syringe and while one patient may feel an intense craving, the other patient may not feel much of a craving at all. Drug cravings can also occur for many years after discontinuation of substance use, can vary based on the type of substance used, and can last as long as 20 minutes for an acute craving, so a long-term and on-demand solution to combat craving is needed. Improving outcomes for SUD patients is a top priority of NIDA, and combatting drug cravings is one way to help patients in their recovery.

Medications such as methadone and buprenorphine may provide some relief for cravings in opioid use disorder, but only 11% of people with an opioid addiction in 2020 received any medication-based treatment. Barriers to treatment can include a lack of health insurance, the stigma surrounding SUD, and treatment not being readily available where the patient lives. In addition, there are no medications currently available for patients with other substance use disorders (e.g., stimulant use disorder; cannabis use disorder; sedative, hypnotic, or anxiolytic use disorder).

NIDA is launching the “Product Prototypes to Combat Drug Craving” Challenge to solicit submissions of product prototypes for decreasing drug cravings and preventing a recurrence of drug use. These product prototypes should be:

• Easily accessible and minimally invasive.
• Available just-in-time and on-demand.
• Suitable for use without detoxification (clearing drugs from a patient’s system) as a precursor.
• Substance-agnostic (i.e., could help a patient with any type of substance use). (NOTE: except alcohol, please see “Statutory Authority” section below.)
• Suitable for use by many different patients (e.g., different ages, genders, geographic locations, income levels) at different stages of recovery.
• Multifaceted and modifiable with different options, where the patient/user can tailor their interaction level or use of the particular intervention or combination of interventions based on their individual needs.

In addition to the above criteria, NIDA is asking that the product prototypes be working prototypes. Working prototypes should be functional and work as they are intended to, but they do not have to be the final version of the product. Working prototypes should be a working product that could be independently tested to see if it works as stated by the submitter, and that could be shown to investors and marketing companies.

Solvers should seek feedback from SUD patients/people who use substances, patient advocates for those with SUD/who use substances (family, concerned significant others, caregivers, peer support specialists, etc.), or addiction professionals (doctors, nurses, therapists, social workers, etc.) on their prototypes prior to submission to this Challenge. Solvers should also use evidence-based methods and any additional information they have access to in the development of their prototypes of self-administered, on-demand, personalized products to decrease drug craving and prevent recurrence of drug use. Solutions (prototypes) submitted to this Challenge could include, but are not limited to, the following and combinations thereof:

• Low- or no-tech approaches (e.g., pamphlet, book, online communication board)
• Mobile apps to:
  • connect individuals to one another (e.g., social media, hotline, smart social community platforms)
  • connect individuals to activities and information (similar to Meetup, Nextdoor, Yelp)
  • guide the individual in different methods to reduce drug craving (e.g., guided meditation or mindfulness)
• Extended or augmented reality (similar to Pokémon Go, Instagram and Snapchat filters)
• Digital therapeutics delivered via phone or web, either by a person or via AI-based chatbots, (similar to Talkspace, BetterHelp, Duolingo, customer service chatbots)
• Hybrid approaches (e.g., combination of patient monitoring via mobile health and therapy delivery)

Additional details on what NIDA is looking for in the proposed prototypes are provided in the Judging Criteria and Submission Requirements sections. NIDA is eager to receive prototypes for multifaceted products that will help patients address their drug cravings in an on-demand manner.

Dates:

• Challenge Launch: March 14, 2022
• Submission Start: March 29, 2022, 9:00 AM ET
• Submission End: August 31, 2022, 6:00 PM ET
• Judging Period: September 12, 2022 to September 30, 2022
• Winner(s) Announced: October 7, 2022

Statutory Authority to Conduct the Challenge

NIDA is conducting this Challenge under the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Reauthorization Act of 2010, as amended [15 U.S.C. § 3719]. The general purpose of NIDA is to conduct and support biomedical and behavioral research, health-services research, research training, and health-information dissemination with respect to the prevention of drug use and the treatment of drug addiction. As this Challenge is consistent with and advances the mission of NIDA as described in 42 U.S.C. 285o in that it seeks to identify intervention strategies to combat drug addiction and drug craving, submissions regarding alcohol use disorder will not be accepted.

Prizes

Amount of the Prize:

The total prize purse is $100,000. NIDA may award a first and second place prize of $50,000 and $35,000, respectively, as well as three honorable mention prizes, depending on the judges’ overall score. All meritorious submissions will be prominently featured on the NIDA website and via social media.

Award Approving Official:

The Award Approving Official will be the Director of NIDA.

Payment of the Prize:

Prizes awarded under this Challenge will be paid by electronic funds transfer and may be subject to Federal income taxes. NIH/NIDA will comply with the Internal Revenue Service withholding and reporting requirements, where applicable. Awardees must be able to provide bank account and routing information in order to receive the award funds and must be prepared to obtain additional documentation or funds transfer information from their financial institution as needed

NIDA reserves the right, in its sole discretion, to (a) cancel, suspend, or modify the Challenge, and/or (b) not award any prizes if no entries are deemed worthy.

Rules

Eligibility Rules for Participating in the Challenge:

The Challenge is open to any participant(s) 18 years of age or older. A participant may be (i) an entity, (ii) an individual, or (iii) a group of individuals (i.e., a team assembled with the purpose of participating in this Challenge).

(1) To be eligible to win a prize under this Challenge, a Participant (whether an individual, group of individuals, or entity) —

• Shall have registered to participate in the Challenge under the rules promulgated by NIDA as published in this announcement;
• Shall have complied with all the requirements set forth in this announcement;
• In the case of a private entity, shall be incorporated in and maintain a primary place of business in the United States, and in the case of an individual, whether participating singly or in a group, shall be a citizen or permanent resident of the United States. However, non-U.S. citizens and non-permanent residents can participate as a member of a team that otherwise satisfies the eligibility criteria. Non-U.S. citizens and non-permanent residents are not eligible to win a monetary prize (in whole or in part). Their participation as part of a winning team, if applicable, may be recognized when the results are announced;
• Shall not be a federal entity or federal employee acting within the scope of their employment;
• Shall not be an employee of the Department of Health and Human Services (HHS, or any other component of HHS) acting in their personal capacity;
• Who is employed by a federal agency or entity other than HHS (or any component of HHS), should consult with an agency ethics official to determine whether the federal ethics rules will limit or prohibit the acceptance of a prize under this Challenge;
• Shall not be a judge of the Challenge, or any other party involved with the design, production, execution, or distribution of the Challenge or the immediate family of such a party (i.e., spouse, parent, step-parent, child, or step-child).
• Shall be 18 years of age or older at the time of submission.

(2) Federal grantees may not use federal funds from a grant award to develop their Challenge submissions or to fund efforts in support of their Challenge submissions.

(3) Federal contractors may not use federal funds from a contract to develop their Challenge submissions or to fund efforts in support of their Challenge submissions.

(4) By participating in this Challenge, each Participant (whether an individual, group of individuals, or entity) agrees to assume any and all risks and waive claims against the federal government and its related entities, except in the case of willful misconduct, for any injury, death, damage, or loss of property, revenue, or profits, whether direct, indirect, or consequential, arising from participation in this Challenge, whether the injury, death, damage, or loss arises through negligence or otherwise.

(5) Based on the subject matter of the Challenge, the type of work that it will possibly require, as well as an analysis of the likelihood of any claims for death, bodily injury, property damage, or loss potentially resulting from Challenge participation, no Participant (whether an individual, group of individuals, or entity) participating in the Challenge is required to obtain liability insurance or demonstrate financial responsibility in order to participate in this Challenge.

(6) By participating in this Challenge, each Participant (whether an individual, group of individuals, or entity) agrees to indemnify the federal government against third party claims for damages arising from or related to Challenge activities.

(7) A Participant (whether an individual, group of individuals, or entity) shall not be deemed ineligible because the Participant used federal facilities or consulted with federal employees during the Challenge if the facilities and employees are made available to all Participants participating in the Challenge on an equitable basis.

(8) By participating in this Challenge, each Participant (whether an individual, group of individuals, or entity) warrants that they are sole author or owner of, or has the right to use, any copyrightable works that the submission comprises, that the works are wholly original with the Participant (or is an improved version of an existing work that the Participant has sufficient rights to use and improve), and that the submission does not infringe any copyright or any other rights of any third party of which the Participant is aware.

(9) By participating in this Challenge, each Participant (whether an individual, group of individuals, or entity) grants to the NIH an irrevocable, paid-up, royalty-free nonexclusive worldwide license to reproduce, publish, post, link to, share, and display publicly the submission on the web or elsewhere, and a nonexclusive, nontransferable, irrevocable, paid-up license to practice, or have practiced for or on its behalf, the solution throughout the world. Each Participant will retain all other intellectual property rights in their submissions, as applicable. To participate in the Challenge, each Participant must warrant that there are no legal obstacles to providing the above-referenced nonexclusive licenses of the Participant’s rights to the federal government. To receive an award, Participants will not be required to transfer their intellectual property rights to NIH, but Participants must grant to the federal government the nonexclusive licenses recited herein.

(10) Each Participant (whether an individual, group of individuals, or entity) agrees to follow all applicable federal, state, and local laws, regulations, and policies.

(11) Each Participant (whether an individual, group of individuals, or entity) participating in this Challenge must comply with all terms and conditions of these rules, and participation in this Challenge constitutes each such Participant’s full and unconditional agreement to abide by these rules. Winning is contingent upon fulfilling all requirements herein.

Disqualification:

Submissions may be disqualified for plagiarism, falsification of any information submitted, use of copyrighted material without permission, and use of profanity, violent images, or nudity. NIDA is not responsible for lost, late, incomplete, invalid, unintelligible, or misdirected entries, which will be disqualified. As this Challenge is consistent with and advances the mission of NIDA, in that it seeks to identify intervention strategies to combat drug addiction and drug craving, submissions regarding alcohol use disorder will not be accepted.

Judging Criteria

Basis Upon Which a Winner Will be Selected. The judging panel, comprised of Department of Health and Human Services (HHS) scientists, will assess each submitted working prototype and written narrative. The judges will consider the following 4 criteria and make recommendations to the award approving official based upon their assessments of the criteria. Each criterion will be scored with a maximum of 10 points.

1. Individualization capability (0-10 points). How easily could an individual tailor the working prototype to their individual needs when a drug craving occurs? How multifaceted, modifiable, and tailorable is the working prototype for different individuals’ needs? Would the working prototype be applicable to patients of many different backgrounds (e.g., different genders, ages, socioeconomic statuses, geographic locations, races/ethnicities, income levels)? Can the working prototype be used for any type of substance use or polysubstance use? Could the working prototype be used without detoxification as a precursor and by individuals at different stages of recovery?
2. Scientific evidence (0-10 points). How well does the scientific evidence outlined in the narrative support the idea of the working prototype? How much data is there to support the working prototype’s use (could include, but is not limited to, scientific literature, preliminary data, and feedback from stakeholders)? Is there basic research or clinical evidence to support the working prototype’s use?
3. Potential for impact (0-10 points). What is the potential for the working prototype to change outcomes for individuals who use or misuse substances? To what extent could the working prototype address the problem of drug craving? How easy would it be to obtain and use for people of many different backgrounds, circumstances, and access to resources? To what extent does the feedback from stakeholders (SUD patients/people who use substances, patient advocates, and/or addiction professionals) support wide use of the working prototype?
4. Feasibility (0-10 points). What is the feasibility potential of developing the working prototype into a widely available product? What is the likelihood of being able to commercialize the working prototype into a final product? What kind of feedback was obtained from the stakeholders (SUD patients/people who use substances, patient advocates, and/or addiction professionals)? To what extent did the stakeholders provide positive or constructive feedback to improve the working prototype? How feasible is it that an individual could begin using the working prototype as soon as they start experiencing a drug craving? How easily could this product be independently tested? 

How to Enter

Registration Process:

Participants may be an individual, a team of individuals, or an entity. Each team that enters the Challenge is required to identify a team leader who is responsible for submitting a Submission Package on behalf of the team. Each entity that enters the Challenge is required to identify a point of contact who is responsible for submitting a Submission Package on behalf of the entity. The individual, team leader, or point of contact must submit the Submission Package, including the completed entry form, through the challenge.gov submission portal by 6:00 PM Eastern Time on August 31, 2022. To access the challenge.gov submission portal, go to the challenge.gov page and click on the orange "Apply for this Challenge" button. You will be asked to create an account, and then you will be able to enter all parts of your completed Submission Package. Instructions on how to fill out all the fields in the submission portal are listed below the Submission Requirements section.

Submission Requirements:

Each submission for this Challenge requires a complete Submission Package. The Submission Package includes a completed registration form that is signed as indicated on the form. The Submission Package must also be accompanied by the following elements, which are described more fully below: title, prototype demonstration, and a written narrative. Both the prototype demonstration and written narrative will be evaluated.

1. Entry Form: Please complete and submit the entry form.
2. Title: Name of product prototype or short description of product prototype.
3. Prototype Demonstration: A brief 5-minute video must be posted to YouTube and the link to the video provided (video does not have to be shared publicly). The video is intended to serve as an elevator pitch for the product and a showcase of the working prototype and all its functions.  In the video:
   • Brief Elevator Pitch. Provide an approximately 30-second, persuasive introductory speech that would spark interest in your working prototype, what it is designed to do, and the impact it could have.
   • Working prototype demonstration and step-by-step use. Demonstrate how the working prototype would be used by an individual experiencing a drug craving, and showcase all of the functionalities of the working prototype. Make sure that someone who has never seen the working prototype before would understand how it works.
   • Individualization and ability to tailor to individual needs. Show how many different ways the working prototype could be used and how an individual could tailor it to their needs in an on-demand fashion.
4. Written Narrative. The narrative must consist of a PDF file with at least 1-inch margins and be no more than five (5) pages long, excluding references. Font size must be no smaller than 11-point Arial. All submissions must be in English. The participants must not use the HHS logo or official seal or the logo of NIH or NIDA in the submissions and must not claim federal government endorsement.
   In the Narrative:
   • Process used to create prototype. Describe the thinking/idea behind the working prototype and why it was created. Outline the development stages from idea to working prototype to describe how it was developed.
   • Supporting scientific evidence. Outline the scientific evidence that supports the idea behind the working prototype. This evidence can be from the scientific literature, from white papers/reports, and from SUD experts. The evidence may also be from animal research or clinical research. Anecdotal evidence or success stories may be included, but the majority of the supporting evidence should be scientific in nature. (NOTE: the list of references does not count toward the 5-page limit.)
   • Feedback obtained from stakeholders. Stakeholders are SUD patients/substance users, patient advocates, and/or addiction professionals who were shown the working prototype and supporting evidence (kind of like a business pitch presentation). Outline how many stakeholders were given a demonstration of the working prototype and what type of stakeholder they are. Include how their feedback was incorporated into the working prototype or will be incorporated in the future as the working prototype goes through product testing. The description should be general in nature and should not include the names of individual stakeholders or other personally identifiable information.

Challenge.gov Submission Portal Instructions:

Once you have clicked on the orange "Apply for this Challenge" button on challenge.gov and are directed to the submission page, follow the directions below to enter your Submission Package:

• Title field: Enter the Title for your submission.
• Brief Description field (optional): Enter a brief description of your product prototype. If you do not wish to include a description, enter "N/A." 
• Description field: Enter "see uploaded files."
• Upload files: Upload completed and signed entry form (link to download is above) and the Written Narrative. The Written Narrative must be a PDF file as specified above, and the entry form may be a PDF or image file (.jpg, .png, or .tiff).
• External URL field (required): Enter the link to your YouTube video. Make sure that your YouTube video is set to "unlisted" so that the judges will be able to view the video using the link provided.

Additional Information

For Further Information Contact: Challenge email: NIDAChallenge@nih.gov

Elena Koustova, Ph.D., MBA
NIDA Challenge Manager
Director, Office of Translational Initiatives and Program Innovations (OTIPI)
National Institute on Drug Abuse (NIDA)
Building 31 Room 1B47B
Bethesda, MD 20814
Phone: (301) 496-8768
Email: elena.koustova@nih.gov

Sara Lioi, Ph.D.
NIDA Challenge Administrator
Office of Translational Initiatives and Program Innovations (OTIPI)
National Institute on Drug Abuse (NIDA)
Building 31 Room 1B59
Bethesda, MD 20814
Phone: (301) 827-5829
Email: sara.lioi@nih.gov