This funding opportunity announcement (FOA) aims to fund applications designed to assess the clinical value of adjuncts prescribed to chronic pain patients together with opioid analgesics.
This funding opportunity announcement (FOA) aims to fund applications designed to assess the clinical value of adjuncts prescribed to chronic pain patients together with opioid analgesics. Adjuncts of interest are either approved by the U.S. Food and Drug Administration (FDA) or have previously been studied as an investigational new drug. Studies with adjuncts of interest should be focused on enhancing analgesia rather than on reducing an adverse effect. A secondary purpose is to increase awareness among opioid prescribers of the potential value of adjunctive therapies by focused data dissemination.
It is hoped that by increasing availability of data describing the use of opioid adjuncts, their use will increase and levels of opioids needed for analgesia will diminish. Reductions in the dosage of opioids prescribed would improve the quality of life of chronic pain patients by reducing opioid-associated adverse effects and lowering the risk of addiction development.
Studies should examine clinical populations and address whether a proposed adjunct can reduce the dose of opioid required for analgesia compared with opioid monotherapy. Applications will be evaluated on the feasibility, scientific rigor, and likely value of the proposed outcomes of randomized control trials (RCTs) to study opioid-adjunct combinations. In addition, the investigators should describe their plan to disseminate the study results. This plan will be evaluated with a view to how effectively the study results will be communicated to the types of healthcare providers who typically prescribe opioids to the chronic pain population under examination.
The purpose of this FOA is to examine adjunctive therapies to reduce the need for opioids in chronic pain patients. Therefore, in the patient group under investigation the pain syndrome should chronologically precede opioid exposure and the opioids should be prescribed as a treatment for the pain.
In the population proposed to be studied, the subjects should be etiologically homogenous and symptomatically well defined. Examples of such chronic pain populations in which opioids often are prescribed include patients with radicular cervical pain, metastatic bone pain, or peripheral neuropathies.
Studies should use an RCT design to examine opioid and adjunct formulations that are either typically used in the outpatient chronic pain population under study or are feasible for daily use in that population. For example, a formulation that requires once-a-day oral dosing is likely to be of much higher programmatic interest than a formulation requiring multiple daily dosing or intrathecal administration. Adjuncts to be examined should preferably be FDA approved, examples of which would include pregabalin, duloxetine, or dronabinol. However, agents that currently are being (or previously have been) studied as investigational new drugs (for example, Sativex/Nabiximols) also will be considered.
Submissions were accepted beginning September 5 and letters of intent are due 30 days before applications are due. For more information about this funding opportunity, visit the NIH grants page.