The goal of this fast-track STTR proposal is to expand buprenorphine maintenance therapy for opioid- dependent patients. Over 2.3 million people in the US are addicted to opiates. Providing effective agonist therapy (methadone or buprenorphine) coupled with behavioral counseling greatly improves outcomes, reduces morbidity, and reduces societal costs. Methadone maintenance treatment has been limited due to complex state and federal regulations and the need for of daily clinic visits. Buprenorphine was developed as an alternative that could be self-administered under the supervision of a specially trained and licensed primary care physician. However, due to a lack of affordable alternatives, patients are usually referred to methadone or similar clinics for counseling, which buprenorphine patients tend to dislike and then tend to drop out of treatment (buprenorphine attrition rates are 50 - 70% in primary care settings). Therefore, a cost-effective method for delivering an accessible and effective form of counseling for office-based buprenorphine is needed. To this end, we propose to develop a buprenorphine-specific version of CBT4CBT (Computer Based Training for Cognitive Behavioral Therapy), a web-based validated behavioral counseling program. In Phase I, our Specific Aim is to test the feasibility of using CBT4CBT adapted for use in buprenorphine certified primary care settings (CBT4CBT-Buprenorphine). We will tailor CBT4CBT for buprenorphine treatment and then conduct a small randomized feasibility comparing it with standard buprenorphine maintenance. In addition, we will develop and evaluate a Physician Tutorial to accompany the CBT4CBT-Buprenorphine program in primary care settings. Test of Feasibility: The CBT4CBT-Buprenorphine group must demonstrate a clinically meaningful effect on increased retention and reduction of illegal drug use and increased retention relative to standard buprenorphine maintenance (at least 50% and 30% improved, respectively). In addition, both clinicians and patients must find CBT4CBT-Buprenorphine is usable (average score of at least 3.5 for both groups on a Likert like scale of 1-4 with 4 indicating `would definitely use CBT4CBT-Buprenorphine again”). In Phase II, our Specific Aim is to determine if the use of CBT4CBT-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 setting. To this end, we will improve CBT4CBT-Buprenorphine, as informed by the Phase I results, and carry out an RCT that is powered to detect significance for reduced opioid use and increased retention in a cost effective manner. Satisfaction and usability will also be evaluated as in Phase I.
Public Health Relevance Statement: Opioid use disorders are at epidemic levels in the United States. This project proposes to develop a validated, cost-effective and accessible strategy for providing evidence based counseling to patients enrolled in primary care based buprenorphine programs
Project Terms: Address; Agonist; base; Behavior Therapy; Behavioral; Buprenorphine; Caring; Clinic; Clinic Visits; clinically significant; Cognitive Therapy; Complex; cost; cost effective; Counseling; Coupled; Dropout; Drops; Drug usage; E-learning; Effectiveness; Enrollment; Environment; Epidemic; evidence base; Goals; improved; improved outcome; Individual; Licensing; Licensure; Maintenance; Maintenance Therapy; Methadone; methadone clinic/center; methadone maintenance; Methods; Monitor; Morbidity - disease rate; mortality; Online Systems; Opiates; Opioid; opioid use; opioid use disorder; Outcome; Outpatients; Patients; Phase; Physicians; Primary Care Physician; primary care setting; Primary Health Care; programs; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Regulation; Sampling; satisfaction; Self-Administered; Small Business Technology Transfer Research; social stigma; Specimen; standard care; success; Supervision; Surveys; System; Testing; Training; trial comparing; United States; Urine; usability
