reSET® Indications for Use:
reSET is intended to provide cognitive behavioral therapy, as an adjunct
to a contingency management system, for patients 18 years of age and
older, who are currently enrolled in outpatient treatment under the
supervision of a clinician. reSET is indicated as a 12-week (90 day)
prescription-only treatment for patients with substance use disorder
(SUD), who are not currently on opioid replacement therapy, who do not
abuse alcohol solely, or who do not abuse opioids as their primary
substance of abuse.
It is intended to:
-
Increase abstinence from a patient’s substances of abuse during
treatment, and
-
Increase retention in the outpatient treatment program.
reSET® Important Safety Information for Clinicians:
Warnings: reSET is intended for patients whose
primary language is English or Spanish with a reading level of 7th grade
or above, and who have access to an Android/iOS tablet or smartphone.
reSET is intended only for patients who own a smartphone and are
familiar with use of smartphone apps (applications).
Clinicians should not use reSET to communicate with their patients about
emergency medical issues. Patients should be clearly instructed not to
use reSET to communicate to their clinician any urgent or emergent
information. In case of an emergency, patients should dial 911 or go to
the nearest emergency room.
reSET is not intended to be used as a stand-alone therapy for substance
use disorder (SUD). reSET does not replace care by a licensed medical
practitioner and is not intended to reduce the amount of face-to-face
clinician time. reSET does not represent a substitution for a patient’s
medication. Patients should continue to take their medications as
directed by their healthcare provider.
Patients with substance use disorder experience mental health disease
and co-morbid medical problems at higher rates than the general
population. Patients with substance use disorder also have higher
baseline rates of suicidal ideation, and suicide attempts, and suicide
completion. Clinicians should engage in their normal care practices to
monitor patients for medical problems and mental health disorders,
including risk for harming others and/or themselves.
The long-term benefit of treatment with reSET on abstinence has not been
evaluated in studies lasting beyond 12 weeks (90 days) in the SUD
population. The ability of reSET to prevent potential relapse after
treatment discontinuation has not been studied.
The effectiveness of reSET has not been demonstrated in patients
currently reporting opioids as their primary substance of abuse.
Please see the Clinician Brief Summary Instructions for reSET.
reSET-O® Indications for Use:
reSET-O prescription digital therapeutic is a 12-week (84 day) software
application intended to increase retention of patients with opioid use
disorder (OUD) in outpatient treatment by providing cognitive behavioral
therapy, as an adjunct to outpatient treatment that includes
transmucosal buprenorphine and contingency management, for patients 18
years or older who are currently under the supervision of a clinician.
reSET-O is indicated as a prescription-only digital therapeutic.
reSET-O® Important Safety Information for Clinicians:
Warnings/precautions: reSET-O is intended for
patients whose primary language is English or Spanish with a reading
level of 7th grade or above, and who have access to an Android/iOS
tablet or smartphone. reSET-O is intended only for patients who own a
smartphone and are familiar with use of smartphone apps (applications).
Clinicians should not use reSET-O to communicate with their patients
about emergency medical issues. Patients should be clearly instructed
not to use reSET-O to communicate to their clinician any urgent or
emergent information. In case of an emergency, patients should dial 911
or go to the nearest emergency room.
reSET-O is not intended to be used as a stand-alone therapy for Opioid
Use Disorder (OUD). reSET-O does not replace care by a licensed medical
practitioner and is not intended to reduce the frequency or duration of
in-person therapy. reSET-O does not represent a substitution for a
patient’s medication. Patients should continue to take their medications
as directed by their healthcare provider.
Patients with opioid use disorder experience mental health disease and
co-morbid medical problems at higher rates than the general population.
Patients with opioid use disorder have higher baseline rates of suicidal
ideation, and suicide attempts, and suicide completion. Clinicians
should undertake standard of care to monitor patients for medical
problems and mental health disease, including risk for harming others
and/or themselves.
The long-term benefit of reSET-O has not been evaluated in studies
lasting beyond 12 weeks (84 days) in the OUD population. The ability of
reSET-O to prevent potential relapse after therapy discontinuation has
not been studied.
Please see the Clinician Brief Summary Instructions for reSET-O.
