In 2010, more than 12 million people reported using prescription pain medications (opioids) non-medically (without a prescription) [1], and 2 million people reported using prescription painkillers non-medically for the first time [1]. In 2009, 1/3 o people older than 12 initiated illicit drug use via non-medical use of prescription drugs [2]. Each year the problem results in more morbidity and mortality (often due to accidental overdose). Office-based opioid treatment (OBOT) with buprenorphine can break the cycle of addiction to opioids. Unfortunately, the quality and availability of treatment for prescription opioid addiction varies, and involves novel agreements and testing (e.g., urine drug testing). Patients must also navigate a complex treatment process with special concerns and unique challenges including fixed and frequent outpatient visits, and following standard procedures to limit diversion and misuse of buprenorphine. Our existing and successful PC/mobile web-based provider education product has provided training to thousands of physicians on the proper prescribing of buprenorphine. In this project, we seek to add a novel supporting framework for patients in treatment for opioid prescription drug addiction called The Patient Support Center. Components include: 1. Patient and provider matched data collection and communication functionality to facilitate open and accurate communication and allow the patient and provider to work in tandem to treat opioid addiction. Via the functionality they can collect and communicate patient data, request information, and communicate plans. We will investigate integrating our service into an EMR;2. A patient support extension that provides patients with the knowledge, skills, encouragement, and awareness to fully participate in OBOT;3. Additional provider training to assist providers in implementing a more patient-centered approach. Phase I focuses on product design work, developing prototype tools, measuring acceptability and usability of the product, and Phase II planning including finalizing evaluation test sites. Phase I completes the product and evaluates its impact using a randomized, cross-over wait-list control design to assess impact, including effect on patient outcomes. We will specifically assess: 1. Short term impact on patient's knowledge, self-efficacy, attitude, and satisfaction, 2. Providers'acceptability and satisfaction with the experience, and 3. Patient outcomes using standardized instruments such as the Brief Addiction Monitor (BAM), and a checklist of required patient behaviors to be completed by the providers. The finalized Phase II product will be integrated it into an electronic health record in one of our evaluation sites.

Public Health Relevance

Treatment of pain with prescription medications such as oxycodone (Oxycontin (R)) can often lead to addiction to opioids and subsequent drug seeking behavior and poor health outcomes. Treatment with buprenorphine is effective and is of tremendous value;however, the treatment requires coordinated attention to multiple details on the part of the patient and the provider if it is to proceed smoothly and succeed. The proposed Patient Support Center will improve the outcomes of patients with addiction to prescription pain medications by enhancing an existing and successful product with: 1. patient-provider data collection and communication tools, 2. patient focused skills training and support, and, 3. specific training for providers in how to work in tandem with patients to help return patients to their baseline, before the onset of addiction to opioid medications.

National Institute of Health (NIH)
National Institute on Drug Abuse (NIDA)
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
Application #
Study Section
Special Emphasis Panel (ZRG1-RPHB-C (10))
Program Officer
Denisco, Richard A
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Clinical Tools, Inc.
Chapel Hill
United States
Zip Code