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Mood and Cognitive Effects of Psilocybin in Healthy Participants (MELO)

Double-blind, randomised, placebo-controlled, within-subject study (n=20) testing six low/microdoses of oral psilocybin (0, 1, 2, 5, 8, 10 mg) in healthy volunteers to identify doses that improve mood, cognition and sleep without hallucinogenic effects.

Target Enrollment
20 participants
Study Type
Phase I interventional
Design
Randomized, quadruple Blind

Detailed Description

This double-blind, randomised, placebo-controlled study administers six separate oral doses of MELOCIN (Psilocybe cubensis powder; 0, 1, 2, 5, 8, 10 mg psilocybin) across six weekly sessions in healthy volunteers to assess safety and potential low-dose effects on mood, cognition and sleep.

Each session involves ingestion of 10 capsules (composition varied to achieve the target dose; placebo day includes 9 placebo + 1 Chaga capsule to mimic after-taste). Sessions are 6–9 days apart with continuous monitoring and blood sampling at multiple acute time points and standardised psychological testing.

Primary objective is safety and tolerability of low/microdoses; secondary outcomes include magnitude of mood, physiological and cognitive effects across doses compared with placebo.

Study Protocol

Preparation

sessions

Dosing

6 sessions
480 min each

Integration

sessions

Study Arms & Interventions

Placebo

inactive

9 placebo capsules + 1 Chaga (Inonotus obliquus) capsule to mimic after-taste

Interventions

  • Placebo
    via Oral• single dose• 1 doses total

    9 placebo + 1 Chaga capsule to mimic mushroom after-taste

1 mg

experimental

Encapsulated Psilocybe cubensis powder delivering 1 mg psilocybin

Interventions

  • Psilocybin1 mg
    via Oral• single dose• 1 doses total

    10 capsules total; composition varied to deliver dose

2 mg

experimental

Encapsulated Psilocybe cubensis powder delivering 2 mg psilocybin

Interventions

  • Psilocybin2 mg
    via Oral• single dose• 1 doses total

    10 capsules total; composition varied to deliver dose

5 mg

experimental

Encapsulated Psilocybe cubensis powder delivering 5 mg psilocybin

Interventions

  • Psilocybin5 mg
    via Oral• single dose• 1 doses total

    10 capsules total; composition varied to deliver dose

8 mg

experimental

Encapsulated Psilocybe cubensis powder delivering 8 mg psilocybin

Interventions

  • Psilocybin8 mg
    via Oral• single dose• 1 doses total

    10 capsules total; composition varied to deliver dose

10 mg

experimental

Encapsulated Psilocybe cubensis powder delivering 10 mg psilocybin

Interventions

  • Psilocybin10 mg
    via Oral• single dose• 1 doses total

    10 capsules total; composition varied to deliver dose

Participants

Ages
18 – 50
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Healthy volunteers
  • 2. Between the age of 18 and 50 years of age
  • 3. Good physical health as determined by medical history, medication history, blood and urinalysis work up
  • 4. Willing to provide informed written consent
  • 5. Able to complete self-assessment questionnaires provided in English
  • 6. Agree to refrain from using any psychoactive drugs, including alcohol, marijuana, or nicotine, at least 24 hours prior to each study visit
  • 7. Agree to refrain from using any non-prescription medication at least 24 hours prior to each study visit

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Unable to complete self-assessment questionnaires in English
  • 2. Reported history of drug abuse or addiction
  • 3. History of any neurological, cardiovascular, or psychiatric disorders or conditions
  • 4. History, family history in first degree (blood) relatives, or current screening symptoms (as determined by positive mini-international neuropsychiatric interview (MINI) questionnaire) of psychiatric illness (including depression, anxiety disorder, post-partum depression, bipolar disorder, schizophrenia)
  • 5. History of insulin-dependent diabetes mellitus
  • 6. Epilepsy with history of seizures
  • 7. Female participants who are pregnant or nursing
  • 8. Prescribed medications with centrally-active serotonergic or gamma-aminobutyric acid (GABA)-receptor interactions, such as monoamine oxidase inhibitors (MAOI) antidepressants, serotonin-inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs), or neurosteroids
  • 9. Pacemaker or implanted cardiac defibrillator
  • 10. Previous head trauma or concussion history

Study Details

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