This new study evaluates the effectiveness of psychedelics in the treatment of binge eating disorder.
Questions and answers
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 time™ spoke with Jim Gilligan, PhD, MBIS, Chief Scientific Officer and Interim CEO of Tryp Therapeutics.
PT: Can you say a bit more about the purpose of the study and how TRP-8802 could change the treatment of people with BED?
Gillian: The use of psychedelics in conjunction with psychotherapy provides clinicians with a tool to penetrate deeper into the patient’s subconscious and potentially gain greater insight into what is motivating aberrant eating behaviors. Overeating disorder can be viewed in part as an addictive behavior related to food. Psychedelics and psilocybin, in particular, have shown benefits in treating patients with addictive behavior.
Additionally, patients with BED often experience anxiety around food and depression, which could be considered comorbidities. Psilocybin has also shown promise in patients with both anxiety and depression. It is important to recognize that a change in patient behavior is of paramount importance. For example, a significant portion of patients who seek bariatric surgery experience immediate benefit, but over time regain weight because their eating behavior 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 towards food.
PT: Why specifically BED? Do you think this might have an effect on eating disorders as a broader category?
Gillian: Binge eating disorder is generally considered a loss of control type eating disorder that is extremely socially limiting and causes feelings of guilt in the individual. These characteristics make it an ideal candidate for psilocybin therapy for eating disorders, as psilocybin has been shown to help other “loss of control” psychiatric problems, such as OCD and alcoholism. . Binge eating disorder is the most common eating disorder, and many experts have noted that it is under-recognized and under-treated. What we are learning about psilocybin-assisted therapy in BED might be relevant for other eating disorders. There is some overlap in clinical presentation, such as body dissatisfaction, as well as links to a history of trauma in some patients with eating disorders.
There is a level of commonality between the different eating disorders, and we believe that psilocybin treatment in conjunction with psychotherapy might have a positive effect on other types of eating disorders. Psilocybin is also currently being investigated in clinical programs in patients with anorexia nervosa.
PT: Approximately 10 million boys and men in the United States will experience an eating disorder at some point in their lives. How do you think this research will specifically impact men/boys?
Gillian: Binge eating disorder is the most common eating disorder in men, so this research may have particular relevance to this population. Our study will include men with binge eating, so hopefully the results can be generalized across genders and not limited to men or women exclusively. Psychedelics have never been tested in bed for men or women before. These preliminary results will hopefully provide useful information for future studies that will examine this topic more closely.
PT: What are some of the differences in presentation/symptoms between the sexes, and how does psilocybin affect them?
Gillian: Men tend to be more secretive and binge denying, so it’s a little harder to get them to be open to change and open up about what’s going on in their lives. Psilocybin can potentially make them more open to dealing with the problem internally and more tolerant of therapy.
This denial by men may also partly explain why there is a greater prevalence of BED in women than in men (ratio of approximately 2:1). However, there are more similarities than differences in the clinical presentation between the sexes. We don’t yet know how psilocybin affects clinical presentation and other outcomes for all genders, but hopefully the current research will pave the way for larger studies.
PT: Psilocybin and eating disorders, especially in men, are unfortunately stigmatized. Do you think this new research can help reduce this stigma?
Gillian: Hopefully this research will reduce the stigma. Again, both genders are studied in this study. Research can help change the view of psilocybin in general to one that sees it as a medicine or a cure. This research, in combination with the expanding field of psychedelic science, can go a long way in reducing this stigma.
PT: What about the question of dosage? With psilocybin taken orally, there can be a thin line between a clinical dose and a bad trip.
Gillian: Tryp recognized early on the variability in response to orally administered psilocybin. Published pharmacokinetic results have revealed that even when given on a weight-adjusted (mg/kg) basis, there were up to 4 times the blood levels, which may prevent some individuals from having a meaningful psychedelic experience, while others had a “bad trip. Other impairments associated with oral administration include the time lag between oral administration and the onset of the psychedelic experience, which can take up to 2 hours, and travel time, which can be an additional 6-8 hours and can potentially be burdensome for both patient and clinicians.
There is also a safety issue with oral dosing. There is a “loss of control” of the oral dosage form, which means that once you take the capsule, you lose control of what will happen if there is a safety issue. TRP-8803, which is Tryp’s proprietary psilocybin, addresses all of these limitations. TRP-8803 has the ability to induce the psychedelic state in approximately 30 minutes while precisely targeting blood levels known to induce the psychedelic state, has also been shown to be safe and has the ability to control the duration of the psychedelic state. experiment and terminate if necessary.
PT: What should clinicians know about using psilocybin to treat patients with binge eating?
Gillian: The results of this study may help inform clinicians in the future about the potential role of psilocybin in conjunction with psychotherapy in the treatment of BED.
Dr. Gilligan is Chief Scientific Officer and Interim CEO of Tryp Therapeutics.