This Phase I application proposes to test the feasibility of AESOP (Assessment and Evaluation for Safe Opioid Prescribing), an integrated suite of software tools that will enable primary care physicians to prevent prescription drug abuse and addiction during long-term opioid therapy. Currently there is no interactive software incorporating validated assessment and treatment protocols for pain management with opioids. AESOP will serve this growing and umet need by offering primary care physicians a computer-assisted algorithm to: (1) assess patients for opioid therapy based on a detailed personal, medical and pain management history (2) identify patients at high risk for addiction or abuse (3) educate patients about risks and benefits of long-term opioid therapy (4) institute waiting periods to discourage """"""""doctor-shopping"""""""" and illicit drug-seeking, (5) implement customized doctor-patient agreements to increase adherence and minimize abuse and diversion, (6) monitor patients at subsequent prescribing visits via in-depth assessment of functional measures that indicate tolerance, addiction, diversion, or abuse. AESOP's evidence-based risk-reduction and transparency will benefit physicians, patients, insurers, and state and federal regulators who monitor Schedule II prescribing. And AESOP will be highly valuable to pharmaceutical companies; as the first computerized learning tool for opioid prescribing, AESOP can be play a central role in Risk Management Plans that opioid manufacturers must develop and deploy in order to win FDA approval for any new opioids. Phase I goals include: 1) Clinical research to validate the centerpiece of AESOP, a computer-assisted physician-patient agreement that governs the prescribing relationship and establishes functional goals for the patient, and 2) In-depth interviews with primary care physicians to ensure that the product's design specifications will conform to existing primary care technology and practice infrastructure. Phase II will develop a beta version of AESOP which can be tested and validated in a primary care setting.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43DA018527-01
Application #
6832985
Study Section
Special Emphasis Panel (ZRG1-BBBP-D (10))
Program Officer
Czechowicz, Dorynne D
Project Start
2004-08-15
Project End
2005-02-14
Budget Start
2004-08-15
Budget End
2005-02-14
Support Year
1
Fiscal Year
2004
Total Cost
$98,438
Indirect Cost
Name
Waterford Life Sciences
Department
Type
DUNS #
City
Washington
State
DC
Country
United States
Zip Code
20009