Request for Information (RFI): Public Comment on Development of a Funding Opportunity Announcement on Translational Research on Minimizing Risks of Managing Pain with Opioids in General and Specialty Medical Settings

Notice Number: NOT-DA-09-006

Key Dates
Release Date:  January 30, 2009
Opening Date: February 1, 2009 
Closing Date: March 31, 2009 

After March 31, 2009, the web link http://www.drugabuse.gov/RFIFeedback/ will be closed.

Issued by
National Institute on Drug Abuse (NIDA), http://www.nida.nih.gov

The National Institute on Drug Abuse seeks input from the scientific and medical community regarding topics and findings in basic and clinical science that could aid in the development and translation of innovative prevention and treatment strategies for reducing prescription drug abuse and addiction in the context of pain management. Information obtained from responses to this RFI will inform the development of an upcoming Funding Opportunity Announcement (FOA) intended to leverage current findings in addiction science to develop new clinical interventions that allow safer prescription of opioid analgesics to manage acute and chronic pain. This RFI will also inform the development of future programmatic activities.

Background

Evidence supports the use of opioid analgesics to treat severe, acute pain and moderate to severe pain associated with cancer and other diseases. However, opioids carry a number of significant potential risks, including the possibility of misuse, abuse and addiction. Because opioids are employed to manage pain in many different medical settings, these risks confront practitioners in disciplines as diverse as primary care, critical care, oncology, geriatrics, and many other medical specialties. The complexities of managing pain in the context of abuse and addiction, coupled with growing concerns about prescription opioid abuse in the US population and recognition of the special needs of returning combatants who suffer from painful conditions, impel the research community to pursue new approaches to improving pain management while mitigating the risk for prescription drug misuse, abuse, and addiction. Research findings from basic and clinical neurosciences, including genetics and epigenetics, functional neuroimaging, social neuroscience, medication and behavioral therapies, prevention, and health services, are likely to yield important insights with potential applications to both general and specialty medical settings.

In order to stimulate translation of scientific discoveries from the bench to the clinic, NIDA anticipates the issuance of an FOA in 2009 to fund 3-5 research initiatives targeting the intersection of pain management and current addiction science. These research initiatives are to be conducted in collaboration with existing interdisciplinary, translational clinical research programs, such as CTSAs.

The goal of the anticipated FOA will be to advance safer, more effective approaches to prescribing opioids for treatment of acute and chronic pain, improving existing modalities to achieve optimal pain relief while minimizing the risk for misuse, abuse, and addiction, and treating abuse and addiction outcomes that may result from the use of prescription opioid analgesics. Applications may include:  (1) formative research to determine participants’ acceptance of specific intervention approaches, (2) early phase trials to characterize the feasibility and effect of interventions or their components on outcomes of interest (including studies examining safety and dose-response relationships), and (3) studies to test and refine intervention procedures to be used in populations of interest.  

Information Requested

In order to aid the conceptualization of the anticipated FOA, this RFI invites the medical and scientific community to respond to the following items:

1)  Describe the needs and concerns of the medical community, including practitioners of medical specialties, regarding prescription drug abuse and addiction in the context of pain management.
2) Describe which findings from the current research can best aid in assessing opioid efficacy in pain management, especially in the context of co-occurring medical and/or psychiatric conditions.
3)  Describe which findings from the current research can best aid in assessing the risks/benefits associated with using opioids in pain management in different patient populations, for example, active military and veterans.
4)  Based on findings from basic and clinical neuroscience research, identify which findings, tools, and methodologies have potential for translation into new clinical practices to reduce the risk of prescription drug abuse and addiction during pain management with opioids.
5) Identify areas of human research that can lead to development of personalized or customized treatments of co-morbid pain and addiction, and/or strategies to identify and care for those patients most at risk of adverse outcomes.
6) Describe what additional considerations, stipulations, or criteria ought to be included in the anticipated FOA in order to support the objectives described in the Background section. This might include research on: addressing other health consequences/side effects of opioid use (drug overdoses, drug interactions, hyperalgesia, opioid tolerance, long-term effects of opioid use), specific development of analgesics with low/no abuse liability, new technologies (e.g. biofeedback) for analgesia, overcoming cultural barriers to service delivery, stigma, financing, implementation, and access challenges.

NOTE:  With regard to the above questions, we welcome the identification of topic areas and research discoveries that can be used to develop interventions that cut across the missions of the NIH Institutes and Centers (ICs), as well as those that are relevant to a specific disease, disorder, or population that falls within the scope of a particular IC’s mission (e.g., prescription abuse prevention and/or treatment in particular population subgroups or medical populations).

Responses

Responses will be accepted through March 31, 2009, and can be entered at the following web site: http://www.drugabuse.gov/RFIFeedback/. Formal acknowledgment of receipt of responses will not be made beyond that provided by the survey utility.
This RFI shall not be construed as a solicitation for applications or as an obligation on the part of the government. The government will not pay for the preparation of any information submitted. Responders should be aware that the information provided will be analyzed and may be used to developing future funding opportunity announcements.  The government cannot guarantee the confidentiality of the information provided.

Inquiries

Questions about this request for information may be directed to either of the following contacts:

Richard Denisco, M.D. M.P.H.
Medical Officer
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse
National Institutes of Health
6001 Executive Boulevard
Bethesda, MD 20892
301-594-4371
deniscor@nida.nih.gov

Petra Jacobs, M.D.
Medical Officer
Center for Clinical Trials Network
National Institute on Drug Abuse
National Institutes of Health
6001 Executive Boulevard
Bethesda, MD 20892
301-443-6697
pjacobs@nida.nih.gov


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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