Enhanced treatment management of opioid-dependence in an office-based setting

Award Information
Department of Health and Human Services
Solitcitation Year:
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Phase I
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Small Business Information
Hubzone Owned:
Woman Owned:
Socially and Economically Disadvantaged:
Principal Investigator
 (978) 631-1108
Business Contact
Phone: (978) 631-1108
Email: michael.davis@medicasafe.com
Research Institution
DESCRIPTION (provided by applicant): The abuse and misuse of opiods is already a significant healthcare problem that is expected to escalate dramatically in the next decade. Traditionally, the treatment of opioid-dependence has been provided in specialty care settings, such as residential therapeutic communities, methadone maintenance clinics, and dedicated inpatient or outpatient treatment programs, yet the availability of these specialty care facilities has not kept pace with demand. As a result, an astounding 80% of opioid-dependent persons currently remain untreated in the U.S. One way policy makers have tried to address this treatment gap is by sanctioning delivery of Buprenorphine therapies by physicians working in office-based environments. Althoughshown to be generally safe and effective, the potential of this treatment modality remains unfulfilled, as only a small percentage of physicians have taken advantage of this opportunity. The reasons cited for this include concern about possible patient abuse and/or misuse of the drug, the intensive demands associated with providing treatment to a population of addicted patients, and the additional effort and legal liabilities involved in complying with burdensome DEA requirements for prescribing controlledsubstances. To address this problem, we propose the development and testing of BupreCare, a comprehensive treatment management solution for delivering Medication Assisted Therapy (MAT) to opioid-dependent persons in an office based setting. BupreCare willbe centered around three primary components - a specialized drug dispensing device (DDD) pre-loaded with a generic formulation of buprenorphine/naloxone that controls access to medications via limited-use pass codes, a web/phone (IVR) patient portal patients use to obtain these pass codes and report on treatment status, and a web-based administrative portal providers use to setup treatment parameters and monitor patient progress. Phase I development efforts will focus on the development and testing of the BupreCare Induction Kit (BIK), which patients and providers can use to facilitate a safe and convenient induction experience. To this end, a high fidelity looks-like, works-like physical prototype of the BIK will be iteratively refined during usabilitytesting, and then used in a pilot study in which the induction experience of patients using BIK is compared to those receiving treatment as usual (TAU). Outcome measures of interest will include opioid usage at 1-week, as well as treatment cost, opioid cravings, symptom severity, and treatment satisfaction. Patient and provider acceptance will also be measured as part of an acceptance study. Finally, the remaining research and development tasks, commercialization plan, and field trial design proposed forPhase II will also be completed. PUBLIC HEALTH RELEVANCE: The use and abuse of opioids is a significant healthcare problem costing the U.S. upwards of 300 billion annually. However, the vast majority of opiod dependent persons remain untreated for the disorder, even though effective medication therapies, such as Buprenorphine, could be made available to them through their own personal physician. This research will develop and test a low-cost treatment management solution designed to increase the practicality, safety, and effectiveness of medication therapies for opioid dependence when delivered by physicians working in an office-based environment, thereby making the treatment more readily available to larger segments of the patient population.

* information listed above is at the time of submission.

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