Are Double-Blind Studies Holding Back Psychedelic Research?

For neuroscientist, entrepreneur, and president of Instituto Phaneros in Brazil, Eduardo Schenberg, witnessing psychedelic-assisted therapy becoming more accepted in the mainstream is one of the most promising aspects of the industry.

However, one area of concern is one he recently addressed in a public letter. “Unblinding is an important confounding in pharmacological research potentially affecting rigor and objectivity of the scientific data underlying evidence-based medicine,” he begins […] “we must critically examine if the proposed research program is pragmatic, if it can improve standards of care and if it can solve conceptual challenges in psychedelic research and psychopharmacology in general.”

What Is Unblinding?

A ‘blind’ study is a clinical trial in which the subject or the investigator (or both) are unaware of which trial product/drug the subject is taking. When only one is blinded to the data this is a ‘single blind’ study. When both do not know the treatment, the study is ‘double-blind’. Unblinding is the process by which the allocation code is broken so that the subject/patient or trial statistician becomes aware of the intervention.

Who Is Blind In Psychedelic Research?

Schenberg tells The Dales Report:

“The blindness is psychedelic research is epistemological blindness related to philosophical issues. Then the question is, why do we need double-blind studies, what is the information they give us, why are they requested and demanded by health authorities, why are scientists doing this in the last five or ten years, and how informative are they?

The main issue here, as revealed in the article by Muthukumaraswamy from New Zealand, that my letter is a commentary on, is that most psychedelic studies are being praised for using the double-blind methodology, but people are unblinded because of the very essence and nature of the psychoactive effects of these drugs. People realize they took a drug. They feel completely different. They close their eyes and have visions that they have never seen before and they don’t stop. How can anyone have such a drug and not realize they got a drug?”

Double-blind is an important methodology, however, “in the case of psychedelics…how can people change their consciousness without realizing they’re changing their consciousness?” he asks.

Science Says The Brain Reigns Supreme; Feelings Are Complicated? 

“Science is, for sure, one of humanity’s most advanced and interesting ways of reasoning and trying to understand the world. But science cannot give us all the answers.

A particular point where science is complicated and has limitations is the study of consciousness. It’s this subjective thing. What does is it feel like to be a person? How does it feel to be sad or happy?

Science is good at measuring the brain but we can’t directly measure our feelings, emotions, hallucinations, visions, dreams, and so on. This is an interesting point where the science of psychedelics gets into philosophy and culture, religion and spirituality. 

The Study Of “Being Human” Needs To Involve More Than The Brain

“One of the main risks right now is the tendency of the mental health sector to equate mental disorders with brain diseases. How do we conceptualize what mental stress and mental disorders are, how are they best treated, and where are they coming from? Are they coming from mere changes in the brain which is a more neurobiological reductionist approach, or are they intimately related with social connection, family issues, emotional problems, childhood trauma, and so on?

Some Of The Questions That Schenberg Addresses In His Letter And This Interview Are:

Is it coherent to strive for pure objectivity if the symptoms of the disorders and the effects of the drugs are mostly subjectively felt?

If we expect to find drugs which minimize or eliminate chronic symptoms including intense fear, anxiety or sadness, how could patients’ feelings change without them becoming consciously aware of it?

And if they do not perceive it, thus preserving masking, wouldn’t it actually mean that the drug did also not exert any useful effect?

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