FDA clears first CBT-based digital therapeutic to treat substance abuse disorders

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reSET® for Sub­stance Use Dis­or­der. Image Cred­it: Pear Therapeutics

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The FDA just approved the first app for treat­ing sub­stance abuse (CNBC):

“The app, devel­oped by a start-up called Pear Ther­a­peu­tics, is designed to be pre­scribed by clin­i­cian and used along­side counseling.

Pear’s tech­nol­o­gy dig­i­tizes a form of talk ther­a­py called cog­ni­tive behav­ioral ther­a­py, or CBT, which focus­es on “exam­in­ing the rela­tion­ships between thoughts, feel­ings and behav­iors”, accord­ing to the Nation­al Alliance on Men­tal Illness.

Stud­ies have found that CBT is an effec­tive treat­ment for sub­stance use dis­or­ders, and recent research sug­gests that it can be admin­is­tered online via a desk­top or mobile app. Abuse of tobac­co, alco­hol and illic­it drugs costs more than $740 bil­lion annu­al­ly in the U.S. alone. Drug-relat­ed deaths have tripled since 2000, accord­ing to the Nation­al Insti­tute on Drug Abuse…As part of the approval process, which McCann said took sev­er­al years, the FDA also cre­at­ed a new clas­si­fi­ca­tion for dig­i­tal ther­a­peu­tics that are deemed low to mod­er­ate risk. That will like­ly make it eas­i­er for oth­er apps to fol­low suit. Cur­rent­ly, dig­i­tal ther­a­peu­tics are being devel­oped to help treat insom­nia, opi­oid depen­dence, chron­ic dis­ease and more.”

FDA per­mits mar­ket­ing of mobile med­ical appli­ca­tion for sub­stance use dis­or­der (FDA news release):

“Today, the U.S. Food and Drug Admin­is­tra­tion per­mit­ted mar­ket­ing of the first mobile med­ical appli­ca­tion to help treat sub­stance use dis­or­ders (SUD). The Reset appli­ca­tion is intend­ed to be used with out­pa­tient ther­a­py to treat alco­hol, cocaine, mar­i­jua­na and stim­u­lant SUDs. The appli­ca­tion is not intend­ed to be used to treat opi­oid dependence.

“This is an exam­ple of how inno­v­a­tive dig­i­tal tech­nolo­gies can help pro­vide patients access to addi­tion­al tools dur­ing their treat­ment,” said Car­los Peña, Ph.D., M.S., direc­tor of the Divi­sion of Neu­ro­log­i­cal and Phys­i­cal Med­i­cine Devices in FDA’s Cen­ter for Devices and Radi­o­log­i­cal Health. “More ther­a­py tools means a greater poten­tial to help improve out­comes, includ­ing absti­nence, for patients with sub­stance use disorder.”

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