Clinical TrialParallelPalliative & End-of-Life DistressPsilocybinNot yet recruiting

Psilocybin Effects on Healthy Aging Biomarkers and Purpose in Life

This Phase I, randomised, double-blind, parallel-group trial (n=50) will study whether psilocybin affects biomarkers of ageing, cognitive function, and purpose in life in medically stable older adults aged 60 to 80 years. Participants will receive one 25 mg dose of psilocybin, two 25 mg doses about 4 weeks apart, three 25 mg doses about 4 weeks apart, or a wait-list comparator. All psilocybin doses are given as 25 mg capsules with therapeutic support. Biomarkers of ageing, including epigenetic and biological clock measures, along with cognitive performance and behavioural measures, will be assessed at baseline and over 12 months, with the primary endpoint at Week 16. The wait-list group will not receive psilocybin during the main study but will be offered a single 25 mg dose with therapeutic support after follow-up is complete.

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Target Enrollment
50 participants
Study Type
Phase I interventional
Design
Randomized, double Blind

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Compound research: PsilocybinTopic research: Palliative & End-of-Life DistressResearch in United States

Detailed Description

The LONG-LIFE study is a randomized Phase I, dose-ranging trial designed to evaluate whether psilocybin impacts aging-related biomarkers, cognitive function, and purpose/meaning in life in medically stable older adults.

Up to 50 participants will be enrolled aged 60-80 who will be randomized with equal allocation to one of four intervention groups: (1) receipt of one 25 mg dose of psilocybin; (2) receipt of two 25 mg doses of psilocybin separated by four weeks; (3) receipt of three 25 mg doses, with each dose separated by four weeks; or (4) wait-list comparator condition that does not receive psilocybin. Biomarkers of aging, cognitive performance, and behavioral measures will be assessed at baseline and longitudinally over a 12-month follow-up period. The primary endpoint occurs at the Week 16 visit. Participants randomized to the wait-list condition will be offered a single 25 mg dose of psilocybin following conclusion of the 12-month follow-up period.

Findings from this Phase I study will inform dose selection for a Phase II study should results indicate a potential impact of psilocybin on relevant study endpoints.

Study Arms & Interventions

Psilocybin 25 mg (one dose)

experimental

Participants in this arm will receive one 25mg dose of psilocybin paired with therapeutic support.

Interventions

  • Psilocybin25 mg
    • one dose• 1 doses total

Psilocybin 25 mg (two doses, 4 weeks apart)

experimental

Participants in this arm will receive two 25mg doses of psilocybin approximately 4 weeks apart paired with therapeutic support.

Interventions

  • Psilocybin25 mg
    • two doses approximately 4 weeks apart• 2 doses total

Psilocybin 25 mg (three doses, 4 weeks apart)

experimental

Participants in this arm will receive three 25mg doses of psilocybin approximately 4 weeks apart paired with therapeutic support.

Interventions

  • Psilocybin25 mg
    • three doses approximately 4 weeks apart• 3 doses total

Wait-list Comparator

inactive

Participants in this arm will not receive psilocybin as part of the main study but will be given the opportunity to receive a single 25mg dose of psilocybin with therapeutic support after their study participation is complete.

Participants

Ages
60 – 80
Sexes
Male & Female

Inclusion Criteria

  • English speaking and able to provide informed consent and complete study procedures
  • Medically healthy, as determined by the screening physician, with no significant medical conditions that would interfere with participation or affect the safety of the subject.

Exclusion Criteria

  • History or presence of any psychiatric or medical condition that, in the opinion of the investigator, could pose a safety risk, interfere with participation, or confound study results.
  • Abnormal ECG at screening that may increase risk during participation (e.g., prolonged QTc, arrhythmias, or other clinically significant findings as determined by the study physician).
  • Unwilling or unable to discontinue medications that may interfere with study participation, as determined by the investigator.

Study Protocol, Arms & Participants

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Study Details

Study Team

Sponsors & Collaborators

Investigators

  • CR
    Charles Raison

Locations

Vail Health Behavioral Health — Edwards, Colorado, United States

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