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

September 15, 2017 by SharpBrains

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

__________

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.”

News in Context

  • The FDA cre­ates new Dig­i­tal Health unit to reimag­ine reg­u­la­to­ry paths in the age of scal­able, AI-enhanced innovation
  • Five rea­sons the future of brain enhance­ment is dig­i­tal, per­va­sive and (hope­ful­ly) bright
  • 2017 Sharp­Brains Vir­tu­al Sum­mit: Brain Enhance­ment in the Dig­i­tal Age (Decem­ber 5–7th, 2017)

Tak­ing cognitive/ emo­tion­al assess­ments and ther­a­pies to scale from Sharp­Brains

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Filed Under: Brain/ Mental Health, Technology & Innovation Tagged With: app, apps, behaviors, CBT, cognitive-behavioral-therapy, digital therapeutics, FDA, feelings, outpatient therapy, Pear Therapeutics, Reset application, substance use disorders, substance-abuse, talk-therapy, thoughts

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