Date of Award
Master of Science (MS)
Frederick J Goldstein, PhD, FCP
David Kuo, DO
Katherine Galluzzi, DO, CMD, F ACOFP
An investigational clinical research study was conducted at an academic healthcare center evaluating memantine as an adjunct to opioid therapy for treatment of chronic low back pain. The N-Methyl-D-Aspartate (NMDA) receptor is located in pain signaling neuronal synapses of the central nervous system. The receptor binds the excitatory neurotransmitter glutamate in addition to NMDA, to increase the magnitude of the perception of pain. Memantine (Namenda©) is a highly tolerated NMDA receptor antagonist which is currently prescribed in the treatment of Alzheimer’s disease. The purpose of the non-randomized pilot study without placebo was to evaluate the use of adding memantine as an adjunctive pain medication to the regimen of patients who use an oxycodone/acetaminophen combination daily for treatment of chronic low back pain (LBP). The effect of Memantine was evaluated using diaries where patients record on a daily basis the amount of oxycodone/acetaminophen used, pain scores, and number of bowel movements. Data was to be collected for six weeks with a two-week preliminary phase, followed by a four-week treatment phase, and then analyzed. The objective is to evaluate, on a preliminary basis, whether patients benefit from addition of memantine to their daily oxycodone/acetaminophen treatment by increased analgesia, a reduction of oxycodone/acetaminophen used, and less constipation. Consequently, limitations to the process of clinical research in an academic healthcare center are evaluated as a result of reduced protected time for researchers and lack of patient participation.
Maurer, Gretchen E., "Clinical Research Challenges: Insight from a Pilot Study at an Academic Healthcare Center" (2013). PCOM Biomedical Studies Student Scholarship. 80.