Yale Clinical Trial Will Evaluate the Efficacy of Psilocybin for OCD Treatment

Researchers from Yale University are planning out a clinical trial to evaluate the efficacy of psilocybin for treating Obsessive Compulsive Disorder (OCD). Currently, only a few controlled trials have explored psilocybin as a potential treatment for the disorder, yielding promising preliminary results. Yet, the studies are inconclusive due to their small sample sizes or lack of control groups.

The trial is the first of its kind as a randomized, two-dose, waitlist-controlled, blinded study with non-directive psychological support. This design will allow more clear, unbiased results and potentially provide an effective treatment option for OCD patients who have not responded to traditional medication and therapies.

Limits and potential of OCD treatment 

Around two to three million adults in the United States have OCD, yet there is no cure or definitive treatment to eliminate symptoms completely. The most common treatments for the condition are Cognitive Behavioral Therapy (CBT) and SSRI medications. While patients may experience some relief from these options, around 40 to 60% of individuals with OCD do not respond adequately to conventional treatments (1).

Psilocybin has demonstrated remarkable potential for its ability to treat a range of psychiatric conditions like major depressive disorder, Post Traumatic Stress Disorder (PTSD), anxiety, substance abuse disorders, and more. The psychoactive substance’s effect on brain function suggests that it can disrupt stubborn and well-established patterns of thought and behavior, making it a promising contender for OCD treatment.

Research has found that psilocybin can enhance neural plasticity, allowing the brain to form new connections and pathways. This feature of psilocybin would be especially helpful for those with OCD, who often find themselves trapped in cycles of obsessive thoughts and compulsive behaviors. 

Trial design and objectives

Participants between the ages of 21 and 55  will be randomly assigned to an immediate treatment group or a waitlist group, which will help minimize bias. The waitlist will serve two primary purposes: to compare immediate and delayed treatment and to address ethical considerations by providing treatment to all participants. 

The participants will receive two fixed doses of psilocybin in a controlled setting. Each dose will be spaced a few weeks apart to evaluate the effects of the treatment over time and its safety profile. 

Licensed therapists will provide emotional and psychological support to the participants without steering the intervention in a particular direction. This support will allow participants to process their experiences in a safe and supportive environment. 

After treatment, participants will be assessed with the Yale-Brown Obsessive-Compulsive Scale, and their results will be compared to their baseline and follow-ups. 

Beyond symptom reduction, the study will monitor any adverse effects and participant responses to evaluate the safety and tolerability of psilocybin treatment in individuals with OCD. This will involve analyzing changes in cognitive and emotional patterns and subjective experience. 

Participants will require a 12-month follow-up visit after their second dosing (2).

Revolutionizing OCD treatment options 

This clinical trial will be a major step forward in the development of alternative treatments for OCD. Further exploration of psilocybin could open up new opportunities for those who have not had luck with existing treatment options. While single-dose studies have shown favorable outcomes, this double dose could allow researchers to evaluate whether an additional dose of psilocybin can enhance or prolong the reduction of OCD symptoms.

Individuals interested in volunteering for the trial will need to meet the eligibility criteria and contact Yale Medicine for more information. 

References

1. Del Casale, Antonio, Serena Sorice, Alessio Padovano, Maurizio Simmaco, Stefano Ferracuti, Dorian A. Lamis, Chiara Rapinesi, et al. 2019. “Psychopharmacological Treatment of Obsessive-Compulsive Disorder (OCD).” Current Neuropharmacology 17 (8): 710–36. https://doi.org/10.2174/1570159x16666180813155017.
2. H. W. Ching, Terence, Lucia Amoroso, Calvin Bohner, Elizabeth D’Amico, Jeffrey Eilbott, Tara Entezar, Madison Fitzpatrick, et al. 2024. “Safety, Feasibility, Tolerability, and Clinical Effects of Repeated Psilocybin Dosing Combined with Non-Directive Support in the Treatment of Obsessive-Compulsive Disorder: Protocol for a Randomized, Waitlist-Controlled Trial with Blinded Ratings.” Frontiers in Psychiatry 14 (January). https://doi.org/10.3389/fpsyt.2023.1278823.