Psilocybin Therapy for Anorexia Nervosa

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether psilocybin therapy can help individuals with anorexia nervosa, a serious eating disorder characterized by restricted eating. It tests two doses of psilocybin, a compound found in certain mushrooms, to assess effectiveness and safety. Suitable participants have had anorexia for at least three years and have tried other treatments. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that psilocybin therapy is generally safe for people with anorexia nervosa. One study found that this therapy was safe, manageable, and acceptable for women with this condition. This finding is promising because anorexia nervosa can lead to serious health problems.

In healthy individuals, psilocybin also appears to be safe, indicating that the drug is well-tolerated in those without eating disorders.

The trial is currently in Phase 2, which typically examines safety and efficacy. While more data is being collected, existing research provides a positive view of the safety of psilocybin therapy. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for anorexia nervosa, which often focus on therapy and nutritional support, COMP360 Psilocybin Therapy uses a psychedelic compound to potentially address the underlying psychological aspects of the disorder. Researchers are particularly excited about psilocybin because it acts on serotonin receptors in the brain, which may help reset thought patterns and improve mental well-being. This approach could offer a novel way to target the root causes of anorexia, offering hope for more effective and faster improvements in symptoms compared to traditional therapies.

What evidence suggests that COMP360 Psilocybin Therapy might be an effective treatment for Anorexia Nervosa?

Research has shown that psilocybin therapy might help treat anorexia nervosa. Early findings suggest that psilocybin is safe and generally well-tolerated by people with this condition. Some studies have found that psilocybin can improve eating habits and overall mental health. Specifically, initial evidence indicates that COMP360 psilocybin therapy, which participants in this trial may receive in either a 1 mg or 25 mg dose, might help people with anorexia by improving their relationship with food and body image. While more research is needed, these results are promising for those considering this treatment. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. 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

2. 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.

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 We are conducting a phase 2 clinical trial investigating the efficacy and safety of investigational COMP360 psilocybin treatment in anorexia nervosa. The ...

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 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05624268

Efficacy, Safety, and Tolerability of COMP360 in ... This is a phase III, international, multi-centre, randomised, parallel group, fixed single-dose, double-blind, placebo-controlled study.