Enhanced Treatment Management of Opioid-Dependence in an Office-Based Setting

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44DA033702-02
Agency Tracking Number: R44DA033702
Amount: $990,950.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIDA
Solicitation Number: PA17-302
Solicitation Year: 2017
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-09-30
Award End Date (Contract End Date): 2020-08-31
Small Business Information
131 VARICK ST STE 934, New York, NY, 10013-1443
DUNS: 803410542
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (319) 331-3653
Business Contact
Phone: (212) 925-0741
Email: matt.ervin@medicasafe.com
Research Institution
PROJECT SUMMARY ABSTRACT Opioid use disorder is the leading cause of accidental death in the USwith overlethal drug overdoses inSAMHSA estimates thatmillion Americans misuse prescription opioids for non medical purposes annuallyPublic health officials and policymakers have acknowledged the urgent need for innovative approaches to the treatment of those with opioid use disorderin spite of thisthe availability and acceptance of medication assisted treatment has not kept pace with the rise of the opioid epidemicCertain strides have been madeas with the Drug Addiction Treatment Act ofwhich allows specifically waived physicians to prescribe Schedule III V drugsBuprenorphine naloxoneB Nwas approved inand is intended to mitigate patientsopioid cravingswhile discouraging injection by precipitating withdrawal when administered parenterallyIn chronic illnesspatient compliance to a prescribed regimen correlates with treatment successandconverselypoor patient compliance correlates with negative outcomesStudies have demonstrated that with B N specificallycompliance is predictive of both relapse and treatment retentionRelapse events are costly in terms of total healthcare expendituresaround $per patientand personally upwards ofyears of potential life lost before the age ofin the United States aloneIt is clear that not only expanding access to treatment is a prioritybut that increasing patient compliance is urgentIn the proposed studywe will examine whether the MedicaSafe BNT can help bolster treatment complianceThis undertaking will be comprised of an initial pilot for study design validationfollowed by a final iteration of software for the existing device and coupled platformandlastlya randomized controlled trial that will aim to take patients from induction to stable maintenance in office based buprenorphine treatmentThe results from the randomized controlled trial will be analyzed and incorporated into further projectsAddiction is a chronic illnessand this project intends to demonstrate that the behavioral support technology developed in Phase I serves as a continuous compliance aid beyond induction and the early stages of treatment PROJECT NARRATIVE There are an estimatedmillion people suffering from opioid addiction who do not have access to treatment in the United Statesresulting in a fatal overdose rate ofpeople per dayAdditionallyboth purposeful and accidental misuse of buprenorphine naloxoneB Nintended for medication assisted treatment is hazardous to public healthin particular by decreasing treatment success rates among patients with lower complianceIn the long termthis project seeks to ameliorate these issues by curbing the negative effects of medication nonadherence and diversionwhile simultaneously increasing provider awareness of patient behaviors and needs

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