Smartphone App to Treat Addiction Was Approved by FDA, but Will People Use It?

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A man holds his smartphone next to a glass of beer as he sits at a bar table. An app, Reset, was approved by the FDA for people already in treatment for substance-use disorders. Charly Triballeau/AFP/Getty

If you’re being treated for substance-use disorder, your phone might soon ask if you’ve used today.

There is, as of last week, an app for that.

The U.S. Food and Drug Administration recently approved Reset, a smartphone app designed by PEAR Therapeutics to help treat substance abuse and addiction, for use by patients already receiving care from a doctor or psychologist.

ResetPicture1 PEAR Therapeutics

The app relies on cognitive-behavioral therapy (CBT), a style of treatment that research has shown to be helpful for substance-use disorders. CBT aids patients in understanding the relationship between emotion, thought and behavior. The underlying principle is that by recognizing situations that cause emotional and behavioral responses (for example, drinking), a person can unlearn harmful habits.  

The approach turns the patient’s smartphone into a vehicle for treatment. Patients receive a prescription and a passcode from the clinician treating them, and then download the app and turn it on using the code.  

Several times a week, the app asks patients to disclose whether they’ve used; to rate the strength of their cravings; and to give numerical ratings to feelings like pain, hunger and loneliness. Over time, the program turns these data points into clear messages that reflect the patient’s behavior: Your urge to drink might spike when you’re feeling tired, and it might dip at times when you report feeling less lonely. Patients can review the data to gain insight into their behavior, and clinicians can use what they learn from the app to inform the issues they focus on when meeting with patients face to face.

At the end of each session, patients also complete a series of “modules” that include videos, audio and text that can help alter their reactions to future difficult situations. For example, one module might include video on how to handle cravings or how to refuse an offer of a beer at a party.

And, it offers rewards. This part of the app works off an idea from substance-use disorder research called contingency management: providing an alternative, benign reward when a patient stays away from the substance of abuse.

In this case, patients could receive a colorful, pixeled “badge” for achieving treatment milestones or a small amount of money provided by the app itself, Corey McCann, the CEO of PEAR Therapeutics, says. The choice between the two is up to the provider.

ResetPicture2 PEAR Therapeutics

The FDA approved Reset based on the results of a 12-week clinical trial. Looking at 399 patients already in treatment—one group using the app, one group not—the study found that those using Reset stayed away from their problem drugs in much higher numbers.

Notably, the FDA did not approve the app for patients who use opioids, writing that it “did not demonstrate effectiveness” for those patients. McCann says the FDA did not approve it for opioid use because of the way the clinical trial was structured. Most patients who are in the care of a doctor for opioid use are taking some kind of medication to ease their symptoms. Patients who were on those other drug treatments, McCann told Newsweek, were ruled out in order not to confound the data.

PEAR is working on a separate product for opioid use and is in the process of running clinical trials, McCann says.

In order to use Reset, patients need a smartphone, a prescription, and someone already treating them. Citing a Pew Research Center study, McCann claims that most people who have substance-use disorder are likely to own a smartphone. Paying for a data plan and having access to a doctor are more urgent challenges, he says.

Assuming these needs are settled, experts say Reset could help augment current treatment.  

“I would certainly use it as an adjunct to care for those already in substance-abuse treatment,” Fred Muench, an addiction specialist and technologist, said.

So far, Reset is the only app of its kind that’s been approved by the FDA. Addiction researchers at Yale and the University of Wisconsin have developed similar programs for people in treatment for substance use that have been shown to work quite well in clinical trials. But none of these programs have had the financial backing of a company required to accrue the data and other requirements for FDA approval.

And the approval is key, because it could lead insurance companies to cover the app, as PEAR Therapeutics hopes will happen.

That coverage is crucial for getting people to actually use it. The app does not carry a heavy time commitment, but having the cost of that time, however minimal (along with the amount PEAR will charge providers for the app's access codes), reimbursed makes it more attractive to treatment centers. And if PEAR can get Reset added to insurance formularies (the list of covered interventions), the incentive to use the app will be stronger.  

Whether insurers are convinced to cover this one app could indicate the potential uptake of treatments like this in the future.

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