South Carolina Department of Corrections and Pear Therapeutics Team up to Support Inmates in Recovery from Substance Use Disorders
September 1, 2022
Camille Griffin Graham Correctional Institution, a state prison for women in Columbia, S.C., is the first in the nation to implement FDA-authorized PDTs in a correctional setting
- Collaboration delivers Pear’s reSET® and reSET-O®, for treatment of substance use disorder and opioid use disorder, for patients affected by addiction
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"We are excited to begin this cutting-edge treatment for our female inmates
According to the
"This project will build on our existing collaborations to treat inmates with substance use disorders, proving that rehabilitation and recovery do go hand in hand,” DAODAS Director
Pear’s innovative FDA-authorized digital treatments are the first of their kind authorized by FDA to treat substance use and opioid use disorders, respectively. The products place evidence-based therapy and treatment accountability in the palm of the patient’s hand.
“Pear and the
Prescription digital therapeutics are a new class of treatments that use software to treat serious disease. Like traditional medicines, these products are evaluated and authorized by regulators like the
The two products being implemented by SCDC -- reSET and reSET-O -- have been measured in real-world use and their therapeutic content studied in randomized controlled trials, with results published in peer-reviewed medical journals3,4. Pear recently released publications showing the potential for improved real-world health outcomes and decreased treatment costs for patients using reSET and reSET-O5-16. Clinicians receive access to clinical dashboards to inform visits with patients. reSET is used as a monotherapy for patients 18 years of age or older with substance use disorder and reSET-O is used in combination with buprenorphine-based medication- assisted treatment for patients 18 years of age or older with opioid use disorder.
This program is supported by the State Opioid Response 2.0 (SOR) Grant of the
reSET Important Safety Information
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,
It is intended to:
- increase abstinence from a patient’s substances of abuse during treatment, and
- increase retention in the outpatient treatment program.
Important Safety Information for Clinicians:
Warnings: reSET is intended for patients whose primary language is English with a reading level of 7th grade or above, and
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.
reSET-O Important Safety Information
Indications for Use
reSET-O is 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
Important Safety Information:
Warnings: reSET-O is intended for patients whose primary language is English with a reading level of 7th grade or above, and
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.
Campbell ANC, Nunes EV,
Matthews AG, et al. Internet-delivered treatment for substance abuse: a multisite randomized controlled trial. Am J Psychiatry. 2014;171(6):683-690.
- Christensen DR, Landes RD, Jackson L, et al. Adding an Internet-delivered treatment to an efficacious treatment package for opioid dependence. J Consult Clin Psychol. 2014;82(6):964-972. doi:10.1037/a0037496.
Yuri A. Maricich, MD, Xiaorui Xiong, PhD, Robert Gerwien, PhD, Alice Kuo, BA Fulton Velez, MD MBA, Bruce Imbert, MD PhD, Keely Boyer, MBA, Hilary F. Luderer, PhD, Stephen Braun, BA, Karren Williams, PhD (2020): Real-World evidence for a prescription digital therapeutic to treat Opioid Use Disorder, Journal of Current Medical Research and Opinion, DOI:10.1080/03007995.2020.1846023.
Fulton F. Velez, Sam Colman, Laura Kauffman, Charles Ruetsch& Kathryn Anastassopoulos(2020): Real-world reduction in healthcare resource utilization following treatment of opioid use disorder with reSET-O, a novel prescription digital therapeutic, Expert Review of Pharmacoeconomics & Outcomes Research, DOI: 10.1080/14737167.2021.1840357
Weijia Wang, Nicole Gellings Lowe, Ali Jalali& Sean M. Murphy(2021) Economic modeling of reSET-O, a prescription digital therapeutic for patients with opioid use disorder, Journal of Medical Economics, 24:1, 61-68, DOI: 10.1080/13696998.2020.1858581
Yuri A. Maricich, Warren K. Bickel, Lisa A. Marsch, Kirstin Gatchalian, Jeffrey Botbyl& Hilary F. Luderer(2020) Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder, Current Medical Researchand Opinion, DOI: 10.1080/03007995.2020.1846022
Fulton F. Velez, Hilary F. Luderer, Robert Gerwien, Benjamin Parcher, Dylan Mezzio& Daniel C. Malone(2021) Evaluation of the cost-utility of a prescription digital therapeutic for the treatment of opioid use disorder, Postgraduate Medicine, DOI: 10.1080/00325481.2021.1884471
Fulton F. Velez, Charles Ruetsch& Yuri Maricich(2021) Evidence of long-term real-world reduction in healthcare resource utilization following treatment of opioid use disorder with reSET-O, a novel prescription digital therapeutic, Expert Review of Pharmacoeconomics & Outcomes Research, DOI: 10.1080/14737167.2021.193968
Fulton F. Velez& Daniel C. Malone(2021) Cost-Effectiveness Analysis of a Prescription Digital Therapeutic for the Treatment of Opioid Use Disorder, Journal of Market Access & Health Policy, 9:1, DOI: 10.1080/20016689.2021.1966187
Yuri A. Maricich, Robert Gerwien, Alice Kuo, Daniel C. Malone& Fulton F. Velez(2021) Real-world use and clinical outcomes after 24 weeks of treatment with a prescription digital therapeutic for opioid use disorder, Hospital Practice, DOI: 10.1080/21548331.2021.1974243
Velez FF, Colman S, Kauffman L, Ruetsch C, Anastassopoulos K, Maricich YA. Comparison of Healthcare Resource Utilization Between Patients
WhoEngaged or Did Not Engage With a Prescription Digital Therapeutic for Opioid Use Disorder. Clinicoecon Outcomes Res. 2021;13:909-916
Velez, F.F., Anastassopoulos, K.P., Colman, S. et al. Reduced Healthcare Resource Utilization in Patients with Opioid Use Disorder in the 12 Months After Initiation of a Prescription Digital Therapeutic.
Adv Ther(2022). https://doi.org/10.1007/s12325-022-02217-y
Shah, N., Velez, F.F., Colman, S. et al. Real-World Reductions in Healthcare Resource Utilization over 6 Months in Patients with Substance Use Disorders Treated with a Prescription Digital Therapeutic.
Adv Ther(2022). https://doi.org/10.1007/s12325-022-02215-0
Luderer H, Campbell A, Nunes E, Enman N, Xiong X, Gerwein R, Maricich Y. Engagement patterns with a digital therapeutic for substance use disorders: Correlations with abstinence outcomes.
Journal of Substance Use Disorders. 132 (2021) 108585. https://doi.org/10.1016/j.jsat.2021.108585
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