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Addiction Medicine

Real-world evidence for a prescription digital therapeutic to treat opioid use disorder

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Pages 175-183 | Received 30 Sep 2020, Accepted 27 Oct 2020, Published online: 07 Dec 2020

References

  • Centers for Disease Control and Prevention. Vital signs: overdoses of prescription opioid pain relievers—United States, 1999–2008. MMWR Morb Mortal Wkly Rep. 2011;60(43):1487–1492.
  • Centers for Disease Control and Prevention. 12 month-ending provisional number of drug overdose deaths by drug or drug class. [cited 2020 Sep 28]. Available from: https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm.
  • Spencer MR, Warner M, Bastian BA, et al. Drug overdose deaths involving fentanyl, 2011–2016. National Vital Statistics Reports. 2019;68(3):108.
  • Substance Abuse Mental Health Services Administration. Key substance use and mental health indicators in the United States: results from the 2018 National Survey on Drug Use and Health. Rockville (MD): Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration; 2019.
  • Wakeman SE, Barnett ML. Primary care and the opioid-overdose crisis – buprenorphine myths and realities. N Engl J Med. 2018;379(1):1–4.
  • National Academies of Sciences Engineering and Medicine. Medications for opioid use disorder save lives. Washington (DC): The National Academies Press; 2019.
  • American Society of Addiction Medicine. National practice guideline for the use of medications in the treatment of addiction involving opioid use. Chevy Chase (MD): American Society of Addiction Medicine, Inc.; 2015.
  • Center for Behavioral Health Statistics and Quality. 2017 National survey on drug use and health: detailed tables. Rockville (MD): Substance Abuse and Mental Health Services Administration; 2018.
  • Substance Abuse and Mental Health Services Administration. National survey of substance abuse treatment services (N-SSATS): 2017. Data on substance abuse treatment facilities. Rockville (MD): Substance Abuse and Mental Health Services Administration; 2018.
  • Duncan A, Anderman J, Deseran T, et al. Monthly patient volumes of buprenorphine-waivered clinicians in the US. JAMA Netw Open. 2020;3(8):e2014045.
  • Marsch LA, Dallery J. Advances in the psychosocial treatment of addiction: the role of technology in the delivery of evidence-based psychosocial treatment. Psychiatr Clin North Am. 2012;35(2):481–493.
  • Pincus HA, England MJ. Improving the quality of psychosocial interventions for mental and substance use disorders: a report from the IOM. JAMA. 2015;314(12):1227–1228.
  • Mansson KN, Salami A, Frick A, et al. Neuroplasticity in response to cognitive behavior therapy for social anxiety disorder. Transl Psychiatry. 2016;6:e727.
  • Stark MJ. Dropping out of substance abuse treatment: a clinically oriented review. Clin Psychol Rev. 1992;12(1):93–116.
  • Simpson DD. Treatment for drug abuse. Follow-up outcomes and length of time spent. Arch Gen Psychiatry. 1981;38(8):875–880.
  • Kang SY, Kleinman PH, Woody GE, et al. Outcomes for cocaine abusers after once-a-week psychosocial therapy. Am J Psychiatry. 1991;148(5):630–635.
  • Harris PM. Attrition revisited. Am J Eval. 1998;19(3):293–305.
  • Simpson DD, Joe GW, Brown BS. Treatment retention and follow-up outcomes in the Drug Abuse Treatment Outcome Study (DATOS). Psychol Addict Behav. 1997;11(4):294–307.
  • Hser YI, Evans E, Huang D, et al. Relationship between drug treatment services, retention, and outcomes. Psychiatr Serv. 2004;55(7):767–774.
  • Marchand KI, Oviedo-Joekes E, Guh D, et al. Client satisfaction among participants in a randomized trial comparing oral methadone and injectable diacetylmorphine for long-term opioid-dependency. BMC Health Serv Res. 2011;11:174.
  • De Novo classification request for reSET (DEN160018). In Health CFD, radiological. Washington (DC): U.S. Food & Drug Administration; 2017.
  • Marsch LA, Guarino H, Acosta M, et al. Web-based behavioral treatment for substance use disorders as a partial replacement of standard methadone maintenance treatment. J Subst Abuse Treat. 2014;46(1):43–51.
  • Budney AJ, Higgins ST. Therapy manuals for drug addiction, a community reinforcement plus vouchers approach: treating cocaine addiction. Rockville, MD: National Institute on Drug Abuse; 1998.
  • Maricich YA, Bickel WK, Marsch LA, et al. Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. Curr Med Res Opin. 2020. DOI:10.1080/03007995.2020.1846022
  • 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.
  • Blonde L, Khunti K, Harris SB, et al. Interpretation and impact of real-world clinical data for the practicing clinician. Adv Ther. 2018;35(11):1763–1774.
  • Dreyer NA. Advancing a framework for regulatory use of real-world evidence: when real is reliable. Ther Innov Regul Sci. 2018;52(3):362–368.
  • Campbell AN, 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.
  • National Institute on Drug A. Principles of drug addiction treatment. A research based guide. Bethesda (MD): National Institutes of Health, U.S. Department of Health and Human Services; 2012. p. 1–75.
  • Haight BR, Learned SM, Laffont CM, et al. Efficacy and safety of a monthly buprenorphine depot injection for opioid use disorder: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2019;393(10173):778–790.
  • Lofwall MR, Walsh SL, Nunes EV, et al. Weekly and monthly subcutaneous buprenorphine depot formulations vs daily sublingual buprenorphine with naloxone for treatment of opioid use disorder: a randomized clinical trial. JAMA Intern Med. 2018;178(6):764–773.
  • Food & Drug Administration. Opioid use disorder: endpoints for demonstrating effectiveness of drugs for medication‐assisted treatment guidance for industry [cited 2020 Sep 29]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/opioid-use-disorder-endpoints-demonstrating-effectiveness-drugs-medication-assisted-treatment.
  • Ronquest NA, Willson TM, Montejano LB, et al. Relationship between buprenorphine adherence and relapse, health care utilization and costs in privately and publicly insured patients with opioid use disorder. SAR. 2018;9:59–78.
  • Mark TL, Hinde JM, Zarkin GA, et al. Adherence to buprenorphine treatment guidelines among individuals with an opioid use disorder who have private insurance. J Subst Abuse Treat. 2020;116:108062.
  • Baumel A, Muench F, Edan S, et al. Objective user engagement with mental health apps: systematic search and panel-based usage analysis. J Med Internet Res. 2019;21(9):e14567.
  • Ling W, Nadipelli VR, Aldridge AP, et al. Recovery from opioid use disorder (OUD) after monthly long-acting buprenorphine treatment: 12-month longitudinal outcomes from recover, an observational study. J Addict Med. 2020;14(5):e233–e240.
  • Soeffing JM, Martin LD, Fingerhood MI, et al. Buprenorphine maintenance treatment in a primary care setting: outcomes at 1 year. J Subst Abuse Treat. 2009;37(4):426–430.
  • Zhu Y, Evans EA, Mooney LJ, et al. Correlates of long-term opioid abstinence after randomization to methadone versus buprenorphine/naloxone in a multi-site trial. J Neuroimmune Pharmacol. 2018;13(4):488–497.
  • Darke S, Ross J, Mills KL, et al. Patterns of sustained heroin abstinence amongst long-term, dependent heroin users: 36 months findings from the Australian Treatment Outcome Study (ATOS). Addict Behav. 2007;32(9):1897–1906.
  • Leonardi C, Hanna N, Laurenzi P, Group IDAC, et al. Multi-centre observational study of buprenorphine use in 32 Italian drug addiction centres. Drug Alcohol Depend. 2008;94(1–3):125–132.
  • Food & Drug Administration. Framework for FDA's real-world evidence program [cited 2020 Aug 25]. Available from: http://www.fda.gov/media/120060/download.
  • Velez FF, Colman S, Kauffman L, et al. Real-world reduction in healthcare resource utilization following treatment of opioid use disorder with reSET-O, a novel prescription digital therapeutic. Expert Rev Pharmacoecon Outcomes Res. 2020. DOI:10.1080/14737167.2021.1840357
  • Bickel WK, Marsch LA, Buchhalter AR, et al. Computerized behavior therapy for opioid-dependent outpatients: a randomized controlled trial. Exp Clin Psychopharmacol. 2008;16(2):132–143.
  • American Academy of Addiction Psychiatry. Poster presentation abstracts. Am J Addict. 2018;27:285–328.