Placebo Induction Project

Overview
Stemming from Institutional Review Board (IRB) and FDA-authorized clinical trials, review of the literature, and discussions with medical professionals, Institute investigators have experience with the placebo response. Our initial study targeting the physiological and psychological parameters of the placebo effect has two stages. Using cortisol levels as a reflection of stress symptoms as the initial model, first-stage participants were screened to determine those suitable for further evaluation. During this time, measurements were taken relating to what is different with the placebo responders versus the non-responders as indicated by a variety of bio-markers. Analysis of these data is expected to provide a model for intentionally inducing the placebo response.

Among the instruments to measure the physiological basis of belief are cytokine and chemokine analysis, and real-time neuroimaging such as CAT scans, MRI, and EEG readings. Validated psychological questionnaires also provide information to determine one’s relation to beliefs, faith, and religiosity before and after the study. Measurements also include Visual Analog Scales (VAS) and the global sense of well being questionnaire, SF-36.

This part of the study provides the placebo-responsive population which will undergo a subsequent series of experiments to determine whether we can artificially induce a placebo response. The response may not be initiated by a pill or injection but by something that has been shown to trigger the change as noted in monitoring the subjects during the above mentioned study. Such an inducer could be sound, light, an energy impulse at a specific frequency.

The potential net effect of this preliminary study is immeasurable. The research itself may provide groundbreaking data in terms of physiological and psychological markers for a range of therapies. The long-term benefits may include increasing scientific knowledge in a variety of areas, enhancing the patient-physician relationship, and lowering the cost of treatment. The Institute’s final objective is to develop a treatment, or combination of treatments, to evoke the placebo response. Again, at this stage of development the agent(s) evoking a placebo response is no longer a placebo but a bona fide therapy.

Project Location and Research
This project is being conducted at the University of Maine in Orono (UM). The Institute is supporting two full-time PhD candidates for three years each, with both focusing exclusively on this project. One student has a background in the medical laboratory fields of biochemistry and physiology, and is a nurse practitioner. She is currently conducting a study to identify modulators of deliberately induced psychosocial stress. Analysis of psychological and physiological variables is providing the means to correlate these data with pathological and resilient responses to stress elicited in the subjects. The second candidate has a master’s degree in chemistry. He is developing a sophisticated technology that allows for the accurate measurement of extremely tiny amounts of a variety of potential biomarkers that may be useful in monitoring a placebo response. Their work is establishing a baseline for further studies.

Conferences
Early conferences formalized the protocols now being followed. Upon completion of the initial study, a conference will be held during which the PhD candidates will present their research to their advisors, Institute staff, and a group of experts in the field in order to critique the work done to date and develop protocols for continued studies. Additional conferences will depend on the outcomes of each round of the data generated by students.