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A Method to Increase Buprenorphine Treatment Capacity and Effectiveness

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 4R42DA041941-02
Agency Tracking Number: R42DA041941
Amount: $1,262,318.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: R42
Solicitation Number: PA15-270
Solicitation Year: 2015
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-08-01
Award End Date (Contract End Date): 2020-07-31
Small Business Information
New Haven, CT 06510-2809
United States
DUNS: 031551851
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
Principal Investigator
 (203) 781-4600
Business Contact
Phone: (203) 691-7451
Research Institution
NEW HAVEN, CT 06511-5991
United States

 Domestic Nonprofit Research Organization

The goal of this fast track STTR proposal is to expand buprenorphine maintenance therapy for opioiddependent patientsOvermillion people in the US are addicted to opiatesProviding effective agonist therapymethadone or buprenorphinecoupled with behavioral counseling greatly improves outcomesreduces morbidityand reduces societal costsMethadone maintenance treatment has been limited due to complex state and federal regulations and the need for of daily clinic visitsBuprenorphine was developed as an alternative that could be self administered under the supervision of a specially trained and licensed primary care physicianHoweverdue to a lack of affordable alternativespatients are usually referred to methadone or similar clinics for counselingwhich buprenorphine patients tend to dislike and then tend to drop out of treatmentbuprenorphine attrition rates arein primary care settingsThereforea cost effective method for delivering an accessible and effective form of counseling for office based buprenorphine is neededTo this endwe propose to develop a buprenorphine specific version of CBT CBTComputer Based Training for Cognitive Behavioral Therapya web based validated behavioral counseling programIn Phase Iour Specific Aim is to test the feasibility of using CBT CBT adapted for use in buprenorphine certified primary care settingsCBT CBT BuprenorphineWe will tailor CBT CBT for buprenorphine treatment and then conduct a small randomized feasibility comparing it with standard buprenorphine maintenanceIn additionwe will develop and evaluate a Physician Tutorial to accompany the CBT CBT Buprenorphine program in primary care settingsTest of FeasibilityThe CBT CBT Buprenorphine group must demonstrate a clinically meaningful effect on increased retention and reduction of illegal drug use and increased retention relative to standard buprenorphine maintenanceat leastandimprovedrespectivelyIn additionboth clinicians and patients must find CBT CBT Buprenorphine is usableaverage score of at leastfor both groups on a Likert like scale ofwithindicating `would definitely use CBT CBT Buprenorphine againIn Phase IIour Specific Aim is to determine if the use of CBT CBT Buprenorphine leads to clinically significant improved outcomes and increased retention for patients in a larger sample of individuals seeking buprenorphine treatment in a primary care settingTo this endwe will improve CBT CBT Buprenorphineas informed by the Phase I resultsand carry out an RCT that is powered to detect significance for reduced opioid use and increased retention in a cost effective mannerSatisfaction and usability will also be evaluated as in Phase I Opioid use disorders are at epidemic levels in the United StatesThis project proposes to develop a validatedcost effective and accessible strategy for providing evidence based counseling to patients enrolled in primary care based buprenorphine programs

* Information listed above is at the time of submission. *

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