Psilocybin for Psychological Distress

Not yet recruiting at 6 trial locations

Overseen By James Downar, MDCM, MHSc

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Bruyère Health Research Institute.

Must not be taking: Lithium, Tramadol, Tapentadol, MAOIs

Disqualifiers: Psychotic disorder, Bipolar, Dementia, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 9

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether small doses of psilocybin, a compound found in "magic mushrooms," can reduce depression, anxiety, and loss of purpose in people with advanced illnesses. The goal is to determine if psilocybin microdosing is a safe and effective way to improve psychological well-being compared to a placebo, which contains no active ingredients. People receiving palliative care and experiencing significant distress from their condition might be suitable for this study. Participants will receive either a low dose of psilocybin or a placebo for two weeks, with the option to try psilocybin afterward. The findings could change how emotional distress is managed in patients with severe illnesses. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

You may need to stop certain medications like lithium, tramadol, tapentadol, monoamine oxidase inhibitors, and atypical antipsychotics. If you're on SSRIs or other antipsychotics, you can continue them, but the dose must stay the same during the trial. Always discuss with your doctor before making any changes.

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

Research has shown that small doses of psilocybin, the active ingredient in "magic mushrooms," are generally safe. Psilocybin has been studied for its impact on mental health. In one small study involving individuals with serious illnesses, small doses of psilocybin reduced mental distress without causing serious side effects.

More broadly, individuals who take small doses of psychedelics often report feeling less anxious and depressed than those who do not. Some may experience mild side effects, such as a temporary increase in blood pressure and anxiety, but these effects usually subside quickly.

Overall, current research suggests that small doses of psilocybin are well-tolerated and could be a promising way to improve mental well-being in people with serious illnesses. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about psilocybin for treating psychological distress because it offers a novel approach compared to traditional treatments like antidepressants and therapy. Unlike conventional options, psilocybin is derived from psychedelic compounds found in certain mushrooms and is believed to work by promoting new neural connections and enhancing emotional openness. This unique mechanism has the potential to provide rapid relief from distress, sometimes in just a single or a few doses, unlike the weeks often required for standard treatments to take effect. Additionally, psilocybin microdosing involves taking very small, non-hallucinogenic amounts, which could minimize side effects and make the treatment more accessible to a broader range of patients.

What evidence suggests that psilocybin microdosing might be an effective treatment for psychological distress?

Research has shown that psilocybin, a substance in magic mushrooms, may help reduce anxiety and depression in people with chronic illnesses. In this trial, participants will receive either psilocybin microdosing or a placebo. A recent study found that very small doses of psilocybin, known as microdosing, improved these symptoms in most participants with advanced illness without causing serious side effects. Additionally, a review of several studies showed that psilocybin significantly lowered depression scores compared to a placebo. Microdosing involves taking tiny amounts, which might be safer and more acceptable for people with advanced illness. Overall, evidence suggests psilocybin could be an effective treatment for psychological distress, especially for those facing serious health challenges. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for patients with advanced illness experiencing psychological distress, such as depression or anxiety. Participants must be willing to take a daily microdose of psilocybin or placebo and can come from various care settings. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

1. Patients \>/=18 years of age with advanced illness under palliative care management, defined as having an estimated 2 to 12 months life expectancy (in the judgment of the palliative care provider)

2. Experiencing psychological distress, defined as a score of 7 or greater on the Depression, Anxiety, or Well-being item of the Edmonton Symptom Assessment System-revised (ESAS-r)

1. Living in the community (i.e., receiving palliative care as an outpatient or through community home visits)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive psilocybin microdose or placebo daily, 4 days per week, for two consecutive weeks

2 weeks

8 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person or virtual)

Open-label access

Participants are offered open-label psilocybin for two consecutive weeks

2 weeks

Open-label extension

Participants may opt into continuation of treatment long-term with a three-week dosing cycle

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Psilocybin

Trial Overview The study tests if a small, non-hallucinogenic dose of psilocybin (2-3 mg) taken four times weekly over two weeks can reduce psychological distress compared to a placebo in palliative care patients. After the initial phase, all participants will have the option to receive psilocybin.

How Is the Trial Designed?

Group I: Psilocybin Microdosing Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Bruyère Health Research Institute.

Lead Sponsor

Citations

1. nccih.nih.gov nccih.nih.gov/health/psilocybin-for-mental-health-and-addiction-what-you-need-to-know

Psilocybin for Mental Health and Addiction: What You ... Microdosing psilocybin can lead to insomnia, increased anxiety and depression, poor mood, low energy, physical discomfort (e.g., gastrointestinal symptoms, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07063862

Study Details | NCT07063862 | Psilocybin Microdose for ... Our results showed psilocybin microdose improved psychological distress in most participants with advanced illness, without serious side effects. Our next step ...

3. hopkinsmedicine.org hopkinsmedicine.org/psychiatry/research/psychedelics-research

Psychedelics Research and Psilocybin Therapy Previous studies by Johns Hopkins Medicine researchers showed that psychedelic treatment with psilocybin relieved major depressive disorder symptoms in adults ...

4. nature.com nature.com/articles/s41598-021-01811-4

Adults who microdose psychedelics report health related ... Adults who microdose psychedelics report health related motivations and lower levels of anxiety and depression compared to non-microdosers.

5. bmj.com bmj.com/content/385/bmj-2023-078084

Efficacy of psilocybin for treating symptoms of depression In our meta-analysis we found that psilocybin use showed a significant benefit on change in depression scores compared with placebo. This is ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S002839082500108X

Side effects of microdosing lysergic acid diethylamide and ... Side effects of microdosing include increases in blood pressure and anxiety. Most adverse effects are mild and transient, resolving post-intoxication.