Overcoming Addiction

TREATMENT CHALLENGES

Staying in treatment is critical for people on their recovery journey

You know treatment for opioid or substance use disorder can be a challenging, multifaceted, ongoing process—especially in between therapy visits when you may not be able to access a counselor or doctor but still need support. The fact is, most individuals who meet the criteria for opioid and substance use disorders never receive proper treatment. Consider the statistics:

  • Of the 20.4 million Americans living with substance use disorder in 2019,1 only 20% received any formal treatment1
  • Of the 2.1 million Americans living with opioid use disorder in 2019,1 only 20% received specialty addiction treatment2

ABOUT PRESCRIPTION DIGITAL THERAPEUTICS

Prescription digital therapeutics are designed to help, anytime, anywhere

What is a prescription digital therapeutic?

Prescription digital therapeutics are a new type of treatment prescribed by doctors, psychiatrists, nurse practitioners, and physician assistants. They are designed to treat disease and are treated much like traditional prescription drugs. However, rather than swallowing a pill or taking an injection, people are treated with software that can be securely downloaded to a smartphone or tablet.

Prescription digital therapeutics use software to treat human disease

next steps

Is a prescription digital therapeutic right for me?

Questions? We’re here to help.

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 Patients:

Warnings/precautions: Do not use reSET to communicate any emergency, urgent or critical information. reSET does not include features that can send alerts or warnings to your clinician. If you have feelings or thoughts of harming yourself or others, please dial 911 or go to the nearest emergency room.

reSET is intended for patients whose primary language is English with a reading level of 7th grade or above, who have access to an Android/iOS tablet or smartphone, and who are familiar with the use of smartphone applications (apps). You should be able to upload data periodically, i.e. have internet/wireless connection access.

reSET is not intended to be used as stand-alone therapy for substance use disorder (SUD) and does not replace care by your provider or outpatient treatment. reSET is not a substitute for your medications. You should continue to take your medications as directed by your provider.

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 safety and effectiveness of reSET has not been established in patients enrolled in opioid treatment programs reporting opioids as their primary substance of abuse.

Please see the Patient 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 Patients:

Warnings/precautions: Do not use reSET-O to communicate any emergency, urgent or critical information. reSET-O does not include features that can send alerts or warnings to your clinician. If you have feelings or thoughts of harming yourself or others, please dial 911 or go to the nearest emergency room.

reSET-O is intended for patients whose primary language is English with a reading level of 7th grade or above, who have access to an Android/iOS tablet or smartphone, and who are familiar with the use of smartphone applications (apps). You should be able to upload data periodically, i.e. have internet/wireless connection access.

reSET-O is not intended to be used as stand-alone therapy for Opioid Use Disorder (OUD) and does not replace care by your provider or outpatient treatment. reSET-O is not a substitute for your medications. You should continue to take your medications as directed by your provider.

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 Patient Brief Summary Instructions for reSET-O.

References:

1. Substance Abuse and Mental Health Services Administration. Key Substance Use and Mental Health Indicators in the United States: Results From the 2019 National Survey on Drug Use and Health. US Department of Health and Human Services; 2020. HHS Publication No. PEP20-07-01-001, NSDUH Series H-55. Accessed May 4, 2020. https://www.samhsa.gov/data/sites/default/files/reports/rpt29393/2019NSDUHFFRPDFWHTML/2019NSDUHFFR090120.htm

2. McCance-Katz EF. SAMHS/HHS: an update on the opioid crisis. Presented at: American Association for the Treatment of Opioid Dependence Conference; March 12-14, 2018; New York, NY. Accessed June 10, 2020. https://www.samhsa.gov/sites/default/files/aatod_2018_final.pdf