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Wednesday, July 24, 2024

Adderall Shortages Are Dragging On—Can Video Games Help?

Earlier this month, facing an increasingly precarious situation, the US Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) joined forces to address the ongoing Adderall shortage. Technically, neither organization has the power to compel pharmaceutical companies to produce mixed amphetamine salts, but in the face of skyrocketing diagnoses for attention deficit hyperactivity disorder (ADHD) in the pandemic era of telemedicine, they wanted to reassure the public that they were looking into potential alternatives to stimulant medications. One suggestion: video games.

In a joint statement, the agencies acknowledged that while they were actively working with the pharmaceutical industry to address the shortages, the FDA did approve a "game based digital therapeutic" to address ADHD symptoms in children back in 2020. While it’s unclear whether digital therapeutics can replace stimulants entirely (they probably can’t), it is clear that people want options beyond amphetamines. And this summer, digital medicine company Akili Interactive dropped the first “over-the-counter” digital therapeutic for managing ADHD symptoms in adults, using the same technology underlying their previously FDA-approved prescription video game for kids.

Having a doctor prescribe a video game sounds unusual, but prescription digital tools aren’t totally new. Nearly six years ago, the FDA cleared reSET, a mobile app designed to help people during outpatient therapy for substance use disorders. The idea that video games can boost cognition isn’t new, either. Despite widespread mid-aughts panic that video games would poison young minds, scientists like Randy Kulman have studied their potential benefits for decades. Kulman is the founder and president of LearningWorks for Kids, an online platform that teaches parents how to help their children practice executive functioning skills while playing regular video games. He is a firm believer that, when approached mindfully, the games on popular platforms like Minecraft and Roblox can help kids strengthen their problem-solving, self-control, and planning. “I call it making them digitally nutritious,” he says.

It’s possible to turn Minecraft into a well-balanced digital meal, but it would be easier if the game were designed to target the cognitive skills a kid was struggling with most. Kulman says the difference between a regular video game and a specially-designed therapeutic video game is like the difference between decaf and espresso: “If you have seven cups of decaf coffee, you’ll have some caffeine. But if you have a little cup of espresso, you’ll get a whole lot of caffeine all at once.” To get such a nutrient-dense game, Kulman says, its missions should challenge specific elements of brain function, like attention, and they should be individualized to each user.

Adam Gazzaley, a neuroscientist at the University of California, San Francisco, and Akili Interactive’s chief scientific advisor, agrees. “Video games can be abused, and you could use them excessively,” he says. “Or, they could be intentionally delivered in a limited time course and used to improve brain function.”

On the surface, Akili Interactive’s prescription pediatric digital therapeutic, EndeavorRx, looks a lot like a regular video game. Like Mario Kart, the game involves steering a hovercraft through whimsical race tracks. (When I tried the demo, it also involved a lot of cursing.) There are two main goals: drive over as many power-ups as possible, and catch specific creatures as they fly toward you, while avoiding others.

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In practice, users are tilting their phone or tablet left and right to steer, while keeping a thumb ready to tap a creature-capturing doodad in the bottom corner of the screen. These tasks are hard on their own and even more challenging to do at once, but this forced multitasking is actually designed to sharpen attention. Because the game is challenging, and demands that you actively focus and shift where your attention is directed, “you’ll get better at all sorts of attentional abilities, because it’s such a hard thing for the human brain to do,” Gazzaley says.

Unlike Mario Kart, the game’s instructions read more like the back of a pill bottle than something you’d find at GameStop. Gameplay is called a “daily treatment,” with a recommended dosage of 25 minutes per day, five days per week for at least a month. Using a companion app, parents can track their child's progress and have information handy in case they want to keep their health care provider in the loop.

There’s no way to “win” EndeavorRx, which Gazzaley says is actually the secret sauce. It’s less of a game and more of a fitness regime, designed to rewire the brain by challenging it over time, “just like the physical body takes time to change if you go to the gym,” he says. “It’s pushing you like a personal trainer would.” An algorithm under the hood constantly adapts the game to the player’s current performance, making sure that it’s always nudging you a little past your comfort zone. There’s no final boss to beat; the only goal is to try your best.

In multiple controlled clinical studies of more than 600 total children ages 8 to 12, scientists found that kids using EndeavorRx showed significant improvements in attention, as measured by the Test of Variables of Attention (TOVA), an FDA-approved assessment of ADHD treatments that involves responding to targets and ignoring distractions on a computer screen. In theory, the test simulates the experience of sitting in a classroom doing something boring, so a child’s TOVA score should predict how focused they’ll be in real life.

But while all of these kids were off medication while participating in the study, only those who had recently stopped taking a stimulant like Adderall showed any significant improvement in behavior, as reported by parents on a rating scale like those used by doctors to diagnose ADHD. So, it’s unclear whether their improvements were caused by the game, or other factors, like parents who are used to monitoring their kids’ medication and behavior being more likely to notice subtle changes in symptoms.

Elizabeth Liddle, an associate professor of translational mental health at the University of Nottingham who is unaffiliated with Akili, says that when it comes to treating ADHD in kids, the most important thing is helping them cope in school. If you think about the classroom—listening to the teacher, sitting still, taking turns—“it’s a list of all the things that children with ADHD find most difficult, even though they might be really, really smart.” Because of this, she’s concerned that significant improvements on the TOVA don’t necessarily mean that EndeavorRx is helping kids get through daily life without medication. “Unless the games are doing that,” she says, “I just don’t think they’re doing enough.”

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This June, Akili released EndeavorOTC, an “over-the-counter” version of the game for adults. It uses the same FDA-approved technology under the hood, but isn’t yet authorized by the agency (although Akili announced last week that they’re preparing to submit adult clinical trial data this year, which could permit them to market EndeavorOTC as an adult ADHD treatment). This over-the-counter game lacks the built-in communication with a doctor that comes with a prescription treatment, but for about $10 a month, any iPhone user can download it from the iOS App Store and commit to the recommended therapy on their own: 25 minutes a day, five days a week, for six weeks.

Barbara Wagner was one of the first adults to participate in the EndeavorOTC clinical trial. She had just been diagnosed with ADHD a year earlier, after retirement-induced boredom made her inattentiveness worse. A doctor started her on a low dose of Adderall, but it wasn’t enough. He suggested taking a higher dose, but her high blood pressure didn’t agree with it. Without sufficient medication, she remembers, “I felt the effects of ADHD creeping back in.” So, when an ad for Akili’s clinical trial popped up on social media, she signed up.

Wagner isn’t a gamer, but she recalls feeling a noticeable change in her behavior days into playing. “After two weeks, I noticed, my goodness—I’m very calmly finishing my game. I’m getting up and cleaning the kitchen. I’m putting things away in my office.” She laughs, and adds, “I asked my husband, ‘Are you noticing a difference in me?’ And he said yes.”

The game has only been on the market for two months, which is barely long enough for early adopters to finish their first round of treatment. But in a clinical trial of 221 adults, which is not yet peer-reviewed, about a third of participants showed improvements on their ADHD-RS scores, the rating scale commonly used to assess and diagnose the disorder in adults. And since this kind of treatment aims to gradually retrain the brain to focus better, Gazzaley is optimistic that its effects won’t disappear as soon as users take a break from playing. “It’s just like going to the gym,” he says. “If you stop going, the effect doesn’t last forever. But it does have enduring benefits.”

Though promising for some, EndeavorRx is only cleared as an adjunctive treatment, meaning that it’s not meant to be a standalone solution for pediatric ADHD management. (EndeavorOTC isn’t cleared by the FDA at all.) And these games can’t hold a candle to Adderall in terms of their potential efficacy: While one-third of EndeavorOTC users saw real-life improvements in their ADHD symptoms, about 70 percent of Adderall users see greater behavioral changes.

“I would never suggest that somebody should go off their medication and play this game,” says Scott Kollins, a clinical psychologist and the chief medical officer at Akili. But in light of the ongoing stimulant shortage, having an additional low-risk tool available can’t hurt. “If your sole source of treatment for ADHD is something your pharmacist cannot give you,” he says, “then why wouldn’t you try this?”

For people like Wagner, who need some kind of treatment to get through day-to-day life but are unable to take stimulants, digital therapeutics offer a welcome alternative to Adderall. When drugs are difficult to access or don’t work for someone, digital therapeutics can offer an experience that, over time, adapts to each user's ability level.

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But this idea—that video games can be a legitimate medical treatment—will take some getting used to if it turns out to be true. Simply put, Kollins says, “we’re just not used to accessing medical products on our phone.” Just because it’s packaged as a game (and might even be kind of fun), Kollins doesn’t want us to forget that it’s medicine, too. “I really try to emphasize that this is a treatment for ADHD that happens to be a video game.”

Kollins and Gazzaley believe that the launch of EndeavorOTC will allow adults who want to improve their attention to claim more agency over their own mental health treatment plans. While the app asks users to attest that they have ADHD, they don’t need to have a health care professional validate their claim.

Given the dire effects of untreated ADHD—academic trouble, increased rates of incarceration, early morbidity—it’s important to find some form of intervention that will work, says Sandra Loo, a pediatric psychologist at the University of California, Los Angeles, who specializes in ADHD assessment. “If medication doesn’t work, then we need to try to find something that’s going to help.” She adds, “All I care about is minimizing impairment and helping people get to the place where they can be the best that they can be.”

This app presents an especially intriguing option for people like me, who fall in what I think of as ADHD purgatory. I’ve always been an overcommitted space cadet, tension-mounted by constant activity and getting by with the help of a finely-tuned assemblage of coping strategies. Many loved ones have suggested that I ought to get formally assessed by a health care provider, but I put off scheduling the appointment for so long that I gave up. And a large part of me felt silly for even entertaining the thought—do I really have ADHD, or am I facing the inevitable consequences of the attention economy? If accessing the medication I may or may not need is so challenging, what’s the point of trying?

For those who fall in this gray zone—OK enough to squeak by without clinical interventions, but struggling enough to crave help—an easily accessible, low-risk, relatively low-cost digital therapeutic like EndeavorOTC might be a good fit. “Nobody looks at the label for Advil to see if it says you can take it to treat a hangover, but they still take it,” says Kollins. He says that whether taking Advil for a self-diagnosed hangover or EndeavorOTC for self-diagnosed attention problems, the consequences of being wrong fall within a range most people are willing to accept. 

“The reality is that our treatments for ADHD have not changed in decades,” Kollins adds, “and our outcomes haven’t changed that much. Here is an opportunity to add another tool to the toolkit.”

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