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Clinically Meaningful Improvements

Science, helping people get their lives back

Our trials are designed to evaluate the safety of low doses of psilocybin, utilizing a novel dosing paradigm to optimize pharmacology while maximizing access and reducing the burden for patients and providers.


Medical Indications

Premenstrual Dysphoric Disorder (PMDD)

Obsessive Compulsive Disorder


Opioid Use Disorder


Clinical Trials

PMDD is characterized by a variety of symptoms that could include marked mood lability, irritability, anger, depressive thoughts with feelings of hopelessness and low self-esteem, anxiety and or feeling tense/on edge, low interest, poor concentration, and changes in sleep and appetite. These symptoms cause significant distress or interference in work or functioning and quality of life.  PMDD is associated with a high risk of suicide. Typically, PMDD is seen in women in the final week before the onset of menses and symptoms typically improve within a few days after the onset of menses to become minimal or absent. The lifetime prevalence of this disorder is approximately 6%. Current treatment options (SSRIs, hormonal treatments) offer partial response and raise tolerability concerns underscoring the need to find safe and efficacious treatment alternatives. There is a high co-morbidity of PMDD with Major depression and other forms of depressive disorders.

OCD is characterized by the presence of repeated and intrusive unwanted thoughts or images that cause distress and anxiety (Obsessions) and an attempt to ignore or suppress these thoughts or images by some other thought or action (Compulsions). For example, excessive and repeated hand washing, ordering, checking, or mental acts like counting, repeating words silently, etc. OCD behaviors are highly disruptive and time-consuming and cause marked impairment in social, occupational, or other areas of functioning. The prevalence of OCD is approximately 1.2% with a slightly higher rate in adult women. The onset of OCD is typically seen during adolescence to young adulthood, and if left untreated has a chronic course and low remission rate of approximately 20%. The risk for suicide or suicide attempts is much higher than in the general population (5.5 odds ratio) with a mean rate of suicide attempts of 14.6% and suicidal ideation of 44.1%. Current treatment options include SSRIs, antipsychotics, and behavior therapies that offer limited benefits.

The prevalence of non-medical opioid use in US adults ranges from 4.1% to 4.7%. The prevalence of prescription opioid use disorder among US adults is 0.6% to 0.9%, with higher use in certain ethnic groups. Actual rates may be higher than in household surveys and when individuals in jails or institutions are included. Globally, age-standardized prevalence is 353 cases/100,000 people. OUD diagnosis is characterized by opioids taken in larger amounts than intended, and this consumption interferes with functioning and unsuccessful attempts to cut down or control opioid use or cravings. OUD is associated with continued use despite failing to meet primary role obligations and cutting down social, occupational, and recreational activities. In addition, opioid-seeking behaviors are also present. Tolerance and withdrawal symptoms are often seen in these individuals. Suicide is a common cause of death in individuals who are regular users of opioids.  Comorbidities include HIV, Hepatitis C, abscesses at injection sites, tuberculosis, cardiovascular disease, etc.  OUD is commonly first seen in late teens and early adults, and rates are increasing globally. Treatment is long-term and associated with brief periods of abstinence in a minority of the population.  OUD is associated with crime, recidivism, domestic violence, and burglary, which has a major societal impact and causes a major drain on the criminal justice system. The mortality rates in OUD are 6-20-fold higher than in the general population. Novel treatments to attain remission and abstinence are a significant unmet need.

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