Psychedelics for the Treatment of Binge Eating Disorder in Males

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Q&A

A new phase II trial, STOP (Study of the Treatment of Overeating Using Psilocybin), is currently underway to determine the efficacy of psilocybin candidate TRP-8802 in combination with psychotherapy for the treatment of binge eating disorder (BED). To learn more about this research, Psychiatric Times™ sat down with Jim Gilligan, PhD, MBIS, the chief science officer and interim CEO of Tryp Therapeutics.

PT: Can you say a bit more about the aim of the study and how TRP-8802 might change treatment for individuals with BED?

Gilligan: The use of psychedelics in conjunction with psychotherapy provides clinicians with a tool to reach deeper into the patient’s subconscious and potentially gain a better perspective on what is driving the aberrant behaviors with respect to eating. Overeating disorders can be viewed in part as addictive behavior relating to food.Psychedelics and psilocybin, in particular, have shown benefit in treating patients with addictive behavior.

In addition, patients with BED often also experience anxiety around food and depression, which might be considered comorbidities. Psilocybin has also shown promise in patients with both anxiety and depression. It is important to recognize that a change in the patient’s behavior is of paramount importance. For instance, a significant portion of patients that seek bariatric surgical intervention achieve an immediate benefit, but over time gain back weight because their behavior towards food has not changed. The neuroplasticity potential of psilocybin, in conjunction with psychotherapy, has the potential to “rewire” these behaviors and improve the patient’s behavior toward food.

PT: Why specifically BED? Do you think this could have an effect on eating disorders as a broader category?

Gilligan: Binge eating is typically viewed as a loss of control type of eating disorder that is extremely socially limiting and causes feelings of guilt for the individual. These characteristics make it an ideal candidate for psilocybin therapy for eating disorders, as it has been shown that psilocybin can help other “loss of control” psychiatric issues, like OCD and alcoholism. Binge eating is the most prevalent eating disorder, and many experts have noted that it is underrecognized and undertreated. What we learn about psilocybin assisted therapy in BED could have relevance for other eating disorders. There is some overlap in clinical presentation such as body dissatisfaction as well as links to histories of trauma in some patients with eating disorders.

There is a level of commonality among the different eating disorders, and we believe that psilocybin treatment in conjunction with psychotherapy could have a positive effect on other types of eating disorders. Psilocybin is also currently being examined in clinical programs in patients with anorexia nervosa.

PT: Approximately 10 million boys and men in the US will experience an eating disorder at one point in their lives. How do you think this research will specifically impact men/boys?

Gilligan: Binge eating is the most common eating disorder among men, so this research may have special relevance to this population. Our study will include men with binge eating disorder, so hopefully, the results will be able to be generalized between sexes and not limited to males or females exclusively. Psychedelics have never been tested in BED for men or women previously. These preliminary results will hopefully provide useful information for future studies that examine this topic more closely.

PT: What are some of the differences in presentation/symptoms among the sexes, and how does psilocybin impact those?

Gilligan: Men tend to be more secretive and in denial about binge eating, so it is a bit more difficult to get them to be open to change and forthcoming about what is going on in their lives. Psilocybin can potentially make them more open to dealing with the issue internally and more accepting of therapy.

This denial by men may also partially account for why there is a greater prevalence of BEDs in females than males (about a 2:1 ratio). However, there are more similarities than differences in clinical presentation across the sexes. We do not know yet how psilocybin impacts clinical presentation and other outcomes across the sexes, but hopefully, the current research will set the stage for larger studies.

PT: Both psilocybin and eating disorders, especially in men, unfortunately, carry a stigma. Do you think this new research can help lessen that stigma?

Gilligan: Hopefully, this research will reduce the stigma. Again, both sexes are being studied in this study. The research may help change the view of psilocybin in general to one that sees it as medicine or curative. This research, in combination with the rapidly expanding field of psychedelic science, may go a long way towards reducing this stigma.

PT: What about the issue of dosage? With orally administered psilocybin, there can be a thin line between a clinical dose and a bad trip.

Gilligan: Tryp recognized early on the variability in response to orally administered psilocybin. Published pharmacokinetics results revealed that even when administered on a weight-adjusted basis (mg/kg), there was up to a 4-fold range in blood levels which could contribute to some individuals not achieving a meaningful psychedelic experience, while others had a “bad trip.” Other deficiencies associated with oral administration include the lapse in time between oral dosing and the start of the psychedelic experience, which can take up to 2 hours, and the length of the trip, which could be another 6 to 8 hours and can potentially be burdensome to the patient and clinicians alike.

There is a safety-related issue as well with oral dosing. There is a “loss of control” of the oral dosage form, meaning once you take the capsule you lose control over what will happen should there be a safety concern. TRP-8803, which is Tryp’s proprietary psilocybin, addresses all of these limitations. TRP-8803 has the ability to induce the psychedelic state within ~30 minutes while accurately targeting blood levels known to induce the psychedelic state, is also shown to be safe, and has the ability to control the length of the experience and terminate if necessary.

PT: What should clinicians know about the use of psilocybin for treating patients with binge eating disorder?

Gilligan: The results from this study may help inform clinicians in the future on the potential role of psilocybin in conjunction with psychotherapy in the treatment of BED.

Dr Gilligan is the chief science officer and interim CEO of Tryp Therapeutics.