Psilocybin for Anorexia

(SPANYA Trial)

Overseen By Marissa Raymond-Flesch, M.D.

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Marissa Raymond-Flesch, MD, MPH

Must not be taking: Amphetamines, Benzodiazepines, Cocaine, others

Disqualifiers: Pregnancy, Bipolar, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests psilocybin therapy for young adults with Anorexia Nervosa that hasn't improved with previous treatments. Participants will attend several therapy sessions, take psilocybin (a psychedelic compound) in controlled settings, and work with family members for support. The goal is to determine if psilocybin can alter how the brain processes habits and thoughts about eating and exercise. This trial might suit individuals aged 18 to 25 who have persistent anorexia symptoms despite treatment attempts and can bring a family member to some therapy sessions. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires that participants refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement for one week before each psilocybin session, unless approved by the research team. Prescription medications are not specifically mentioned, so it's best to discuss your current medications with the research team to see if any adjustments are needed.

Is there any evidence suggesting that psilocybin therapy is likely to be safe for humans?

Research has shown that psilocybin therapy is generally safe and well-tolerated for people with anorexia nervosa. In earlier studies, participants did not experience serious side effects. This is encouraging because anorexia nervosa is a very sensitive condition. Some research even suggests that psilocybin therapy is not only safe but also acceptable to patients, as they felt comfortable with the treatment process.

While researchers study psilocybin for treating anorexia, they are also testing it for other conditions, indicating growing interest in its potential benefits. Overall, the evidence supports the idea that psilocybin can be used safely with proper supervision and support. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Anorexia?

Unlike the standard treatments for anorexia, which often involve therapy and medications like antidepressants or antipsychotics, psilocybin therapy offers a novel approach. Psilocybin, a psychedelic compound, works by targeting serotonin receptors in the brain, potentially altering perception and mood in ways that standard medications do not. Researchers are excited about this treatment because it includes both dosing and integration sessions, which may foster profound changes in mindset and behavior, offering hope for those who haven't responded well to conventional therapies.

What evidence suggests that psilocybin might be an effective treatment for Anorexia?

Research shows that psilocybin therapy, which participants in this trial will receive, might help treat anorexia nervosa. Earlier studies found this therapy safe and acceptable for people with anorexia. This is promising because anorexia can lead to serious health problems. Some studies have noted improvements in eating habits and mental health after psilocybin treatment. Early results suggest that psilocybin may help people think more flexibly, potentially changing the rigid thoughts and behaviors linked to anorexia. Overall, researchers are considering psilocybin therapy as a possible new option for those facing this difficult condition. ^{1 2 3 4 5}

Who Is on the Research Team?

Marissa Raymond-Flesch, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for young adults with severe Anorexia Nervosa who haven't improved with standard treatments. Participants must have two family members willing to be involved, one of whom will attend certain therapy sessions.

Inclusion Criteria

I have been diagnosed with Anorexia Nervosa.

I am currently experiencing symptoms of Anorexia Nervosa.

I understand the study and can give my consent.

Exclusion Criteria

I do not have any uncontrolled neurological conditions.

Simultaneous enrollment in another clinical trial

Significant and uncontrolled gastrointestinal illness at the discretion of the investigator

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preparatory Sessions

Three preparatory sessions for psilocybin therapy, including psychoeducation for family members

3 weeks

3 visits (in-person)

Psilocybin Dosing and Integration

Psilocybin dosing session one (20mg), two integration sessions, psilocybin dosing session two (30mg), and four final integration sessions

4 weeks

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Psilocybin

Trial Overview The study tests psilocybin therapy's effect on Anorexia symptoms in young adults. It includes preparatory and integration sessions, two dosing sessions of psilocybin (20mg then 30mg), and measures changes in eating behaviors.

How Is the Trial Designed?

Group I: Psilocybin Therapy Experimental Treatment 2 Interventions

The psilocybin therapy will include three preparatory sessions, psilocybin dosing session one (20mg), two integration sessions, psilocybin dosing session two (up to 30mg), and four final integration sessions

Psilocybin is already approved in United States, European Union for the following indications:

Approved in United States as Psilocybin for:

• Treatment-resistant depression (TRD) under Breakthrough Therapy designation

Approved in European Union as Psilocybin for:

• Treatment-resistant depression (TRD) under PRIME designation

Who Is Running the Clinical Trial?

Marissa Raymond-Flesch, MD, MPH

Lead Sponsor

Trials

1

Recruited

40+

Published Research Related to This Trial

In a survey of 1993 individuals who experienced challenging psilocybin trips, 39% rated their experience as one of the most difficult of their lives, with 11% reporting risks of physical harm, particularly influenced by dose and lack of support.

Despite the challenges, 84% of respondents felt they benefited from the experience, suggesting that while adverse effects can occur, the overall incidence of serious psychological distress is low, especially in controlled settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey study of challenging experiences after ingesting psilocybin mushrooms: Acute and enduring positive and negative consequences. Carbonaro, TM., Bradstreet, MP., Barrett, FS., et al.[2018]

A meta-analysis of psilocybin studies found that higher doses of psilocybin are associated with stronger subjective experiences, particularly in areas like perceptual alterations and ego dissolution, based on data from standardized questionnaires.

Challenging experiences were less affected by dose, suggesting that individual and environmental factors also play a significant role in the psilocybin experience, indicating that these findings are most relevant in controlled settings rather than recreational use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-response relationships of psilocybin-induced subjective experiences in humans. Hirschfeld, T., Schmidt, TT.[2022]

Psilocybin-containing mushrooms, commonly known as hallucinogenic or 'magic' mushrooms, rapidly affect the central nervous system within 0.5-1 hour of ingestion, leading to effects such as ataxia, hyperkinesis, and hallucinations.

The review discusses the significant toxicity associated with these mushrooms, highlighting the need for awareness and understanding of their pharmacology, clinical effects, and potential treatment for adverse reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hallucinogenic mushrooms]. Reingardiene, D., Vilcinskaite, J., Lazauskas, R.[2018]

In a feasibility study involving 10 adult females with anorexia nervosa, a single 25-mg dose of synthetic psilocybin was found to be safe and well-tolerated, with no significant adverse effects on vital signs or ECG.

Participants reported that the psilocybin treatment was generally acceptable, suggesting potential for further research into its efficacy as a novel treatment for anorexia nervosa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psilocybin therapy for females with anorexia nervosa: a phase 1, open-label feasibility study. Peck, SK., Shao, S., Gruen, T., et al.[2023]

A long-term follow-up of 15 participants from a previous trial showed that psilocybin-assisted psychotherapy led to sustained reductions in anxiety, depression, and other distressing symptoms, with 60-80% of participants still experiencing significant improvements 3.2 to 4.5 years later.

Participants reported that the psilocybin therapy was among the most meaningful experiences of their lives, indicating its potential to enhance psychological and spiritual well-being in patients facing life-threatening cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term follow-up of psilocybin-assisted psychotherapy for psychiatric and existential distress in patients with life-threatening cancer. Agin-Liebes, GI., Malone, T., Yalch, MM., et al.[2023]

Psilocybin, a serotonergic psychedelic, has shown promise in treating various psychiatric disorders, including depression and substance use disorders, with 9 clinical trials conducted between 2000 and 2020.

The treatment is generally well tolerated with limited side effects, and some patients with treatment-resistant conditions have experienced significant long-term improvements after just a few sessions, indicating its potential efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment with psilocybin: applications for patients with psychiatric disorders]. Breeksema, JJ., Koolen, MHB., Somers, M., et al.[2021]

In a study examining the effects of Psilocybe cubensis and Panaeolus cyanescens mushrooms on heart cells, the extracts did not worsen hypertrophy caused by endothelin-1 and provided protection against TNF-α-induced cell injury.

The findings suggest that these mushroom extracts can be safely used in controlled conditions for potential therapeutic benefits in heart disease, although caution is advised with higher concentrations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects and safety of Psilocybe cubensis and Panaeolus cyanescens magic mushroom extracts on endothelin-1-induced hypertrophy and cell injury in cardiomyocytes. Nkadimeng, SM., Steinmann, CML., Eloff, JN.[2021]

A pilot study is currently underway at Imperial College London to explore the feasibility and potential efficacy of psilocybin-assisted therapy for anorexia nervosa, involving 20 female participants who will receive three doses of psilocybin over 6 weeks.

Public Patient Involvement (PPI) has played a crucial role in shaping the study by providing insights from individuals with lived experience of anorexia, helping to identify barriers and understand recovery, which may enhance participant engagement and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study Protocol for "Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study". Spriggs, MJ., Douglass, HM., Park, RJ., et al.[2023]

Psilocybin shows promising effects in alleviating anxiety, depression, and emotional distress in palliative care patients, with a favorable safety profile, based on recent studies and reports.

Despite its potential benefits, psilocybin is not yet approved for therapeutic use in the U.S., and significant barriers exist for access, particularly for vulnerable populations like the elderly and those in palliative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psilocybin in Palliative Care: An Update. Whinkin, E., Opalka, M., Watters, C., et al.[2023]

A 30-year-old man experienced severe symptoms, including vomiting and muscle pain, after receiving an intravenous injection of Psilocybe mushroom extract, highlighting the potential dangers of using hallucinogenic substances in non-traditional ways.

The patient showed rapid improvement with supportive care, suggesting that while the effects of Psilocybe mushrooms can be serious, timely medical intervention can effectively manage the symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous mushroom poisoning. Curry, SC., Rose, MC.[2019]

Psilocybin, a prodrug for psilocin, shows strong agonist activity at the serotonin 5-HT2A receptor, which is responsible for its psychedelic effects, and has been shown to have nanomolar affinity for various serotonin receptor subtypes in both in vitro and in vivo studies.

In mouse experiments, psilocybin and related compounds induced head twitch responses, a sign of psychedelic activity, which were blocked by a 5-HT2A antagonist, confirming the involvement of this receptor in their effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Structure-Activity Relationships for Psilocybin, Baeocystin, Aeruginascin, and Related Analogues to Produce Pharmacological Effects in Mice. Glatfelter, GC., Pottie, E., Partilla, JS., et al.[2023]

Psilocybin, a hallucinogenic compound found in certain mushrooms, has been associated with increasing rates of drug abuse, highlighting the need for comprehensive pharmacological understanding.

Despite its historical use in the 1960s for experimental medical purposes, recent research has only begun to uncover the pharmacological properties of psilocybin, indicating a gap in knowledge that needs to be addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pharmacology of psilocybin. Passie, T., Seifert, J., Schneider, U., et al.[2016]

Citations

1. nature.com nature.com/articles/s41591-023-02455-9

Psilocybin therapy for females with anorexia nervosa Results suggest that psilocybin therapy is safe, tolerable and acceptable for female AN, which is a promising finding given physiological dangers.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05481736

Study Details | NCT05481736 | Efficacy and Safety of ... This study aims to explore the efficacy and safety of COMP360 25 mg as compared to COMP360 1 mg (control condition) administered with psychological support

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12307571/

Psilocybin in the treatment of eating disorders: a systematic ... The secondary outcomes were changes in eating psychopathology, BMI, and general psychopathology assessed up to 3 months after treatment. Weight ...

4. compasspathways.com compasspathways.com/our-work/anorexia-nervosa/

Anorexia Nervosa Compass Pathways supports people suffering with mental health challenges. Currently we investigate the effects of psylocibin therapy in anorexia nervosa.

5. eatingdisorders.ucsd.edu eatingdisorders.ucsd.edu/about/press/docs/SOBP%20Press%20Release.pdf

COMP360 psilocybin therapy shows potential in exploratory ... The results provide promising preliminary evidence that COMP360 psilocybin therapy could help people living with anorexia nervosa and severe ...