Psilocybin Therapy for Anorexia Nervosa

Recruiting at 5 trial locations

Overseen By Medical Director, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: COMPASS Pathways

Must not be taking: Antidepressants, Psychedelics

Disqualifiers: Bipolar, Psychotic disorders, Personality disorders, Suicide risk, Substance use, 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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

32 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a treatment using psilocybin, a substance from certain mushrooms, to help people with anorexia nervosa. The treatment aims to change brain function to improve mental health, especially for those who haven't responded well to other treatments. Psilocybin is a naturally occurring psychedelic that has shown promise in treating various psychiatric disorders, including mood and substance use disorders.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications at least two weeks before the trial starts. If you are taking fluoxetine (Prozac), you must stop immediately and have a four-week period without it before the trial begins.

What data supports the effectiveness of the drug COMP360 Psilocybin Therapy for treating anorexia nervosa?

Research suggests that psilocybin therapy is safe and tolerable for people with anorexia nervosa, and it has shown promise in treating other mental health conditions like depression. This opens up possibilities for further studies to explore its effectiveness in improving symptoms of anorexia nervosa. ^{1 2 3 4 5}

Is psilocybin therapy safe for humans?

Research suggests that psilocybin therapy is generally safe for humans, with studies showing mild and temporary side effects. In a study with women with anorexia nervosa, no significant changes in heart function, vital signs, or mental health were observed, and any side effects were mild and resolved quickly. ^{1 2 3 4 5}

How is psilocybin therapy different from other treatments for anorexia nervosa?

Psilocybin therapy is unique because it uses a psychedelic compound to potentially address the brain mechanisms involved in anorexia nervosa, which is different from traditional treatments that often focus on behavioral and nutritional interventions. This therapy involves taking psilocybin in a controlled setting with psychological support, aiming to improve symptoms by affecting brain function and cognitive flexibility. ^{1 2 3 4 5}

Eligibility Criteria

Adults aged 18+ with Anorexia Nervosa (AN), either restrictive or binge-purging type, who have tried at least one treatment in the past 3 years. Participants must be medically stable, not currently abusing substances, and have a BMI between 15-20 kg/m2. They should not have serious psychiatric conditions like bipolar disorder or schizophrenia, nor a history of substance use disorders within the last year.

Inclusion Criteria

My BMI is between 15 and 20, and I may need special approval if it's between 16 and 18.5.

I have stopped taking certain medications for two weeks, and for Prozac, four weeks before starting the trial.

My overall health is stable according to recent medical exams.

Exclusion Criteria

I haven't used psychedelics like LSD or psilocybin in the last year.

I do not have a history of serious psychiatric conditions like bipolar or schizophrenia.

Significant suicide risk as defined by (1) suicidal ideation as endorsed on items 4 or 5 on the C-SSRS within the past year, at screening or at baseline, or; (2) suicidal behaviours within the past year or; (3) clinical assessment of significant suicidal risk during participant interview

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive COMP360 Psilocybin therapy with psychological support

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Treatment Details

Interventions

• COMP360 Psilocybin Therapy

Trial Overview The trial is testing COMP360 Psilocybin therapy's effectiveness and safety for treating Anorexia Nervosa. It's an early-stage study to see how well it works and what risks are involved when given to people with AN under controlled conditions.

Participant Groups

Group I: 25 mg COMP360 Psilocybin Experimental Treatment 1 Intervention

25 mg COMP360 Psilocybin

Group II: 1 mg COMP360 Psilocybin Active Control 1 Intervention

1 mg COMP360 Psilocybin

Who Is Running the Clinical Trial?

COMPASS Pathways

Lead Sponsor

Trials

15

Recruited

1,400+

Findings from Research

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 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]

Psychedelic-assisted therapy (PAT) shows promise as a safe and potentially effective treatment for eating disorders, particularly anorexia nervosa, although the exact efficacy is still being established through early clinical trials.

Current research indicates that classic psychedelics may work through various mechanisms that are relevant to the pathology of eating disorders, but high-quality data supporting their use in this context is still limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychedelic-Assisted Therapy for People with Eating Disorders. Gukasyan, N., Schreyer, CC., Griffiths, RR., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Psilocybin for anorexia nervosa: If it helps, let's learn how. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Rethinking Therapeutic Strategies for Anorexia Nervosa: Insights From Psychedelic Medicine and Animal Models. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Psilocybin therapy for females with anorexia nervosa: a phase 1, open-label feasibility study. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Study Protocol for "Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study". [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Psychedelic-Assisted Therapy for People with Eating Disorders. [2023]