A new article in the Journal of American Medical Association (JAMA) Psychiatry has outlined four specific challenges to psychedelic therapy. These challenges included:
- The design of psychedelic study trials
- Defining psychedelic therapy
- Scaling up psychedelic therapy
The article, written by Jacob Aday, Robin Carhart-Harris, and Joshua Wooley, pointed out that the double-blinded randomized controlled trial (DB-RCT) remains the gold standard method for determining if an intervention works.
The problem is that it’s pretty hard to have a blind psychedelic test. A patient will know whether they are experiencing a hallucinogenic drug or not.
According to the authors, changes related to study design, participant recruitment, incomplete disclosure of information to participants, and active placebos could improve methodological rigor in psychedelic clinical trials.
“Psychedelic therapy research represents an opportunity to rigorously revisit trial designs and their underlying assumptions,” the article stated. “This includes, one might argue, the fallibility of the DB-RCT itself, as well as considering alternative designs, such as pragmatic clinical trials.”
How Does Psychedelic Therapy Work?
The authors pointed out that psychedelic therapy typically involves the combination of a drug and therapist session. However, this isn’t a defined standard, something the authors suggest either it becomes or that a strong case needs to be made against it.
Then there is the challenge of clarifying exactly how the drugs work. Is it at a cellular level or is it affecting the brain network functions?
The authors also suggest that it could be just the effect of the experience the patient feels during a psychedelic session.
With psychedelic therapy, the authors stated, there is concern that individuals with a diagnosis or immediate family history of a psychotic or bipolar disorder may be at increased risk of adverse events (e.g., prolonged psychosis), but more research is needed.
There is also the risk that a patient could experience what is known as a “bad trip.”
The article also brings up a sensitive point about vulnerability: “The heightened state of vulnerability and suggestibility induced by psychedelic drugs raises the risk of sexual misconduct by health care professionals.”
Another highlighted risk is that some patients, after going through psychedelic treatments, make drastic life changes. They change career, end marriages, and sometimes alter their metaphysical beliefs. While some of these changes can be prosocial, they might not be the case for all.
Currently, psychedelic studies include arduous screening, where hundreds apply to be one of a small number of participants. This enthusiasm to be a part of the study, according to the authors, means researchers get very willing patients that might lead to the study having a better outcome.
The authors also note that these sessions are time consuming and expensive. There are not many models for drug-assisted therapy, and the FDA doesn’t regulate psychotherapy. Throw in insurers, medical systems, and regulatory bodies affecting the process, and real-world management of such therapies becomes uncertain.
The authors agreed that psychedelic therapy has demonstrated intriguing promise for a variety of psychiatric conditions, at a time when there is a great need for novel and efficacious treatments. However, they caution against both obstinate cynicism and unbridled enthusiasm.
“Rather, let us carefully consider and weigh both the benefits and challenges that have emerged, while maintaining clinical equipoise,” they wrote. “Confronting difficult issues head-on should help anticipate and mitigate risk, maximize opportunities for learning, increase credibility of the field’s findings, and ultimately facilitate the development of improved treatments for those in need.”