Clinical TrialParallelInterpersonal Functioning & Social ConnectednessPlaceboPsilocybinNot yet recruiting

The Effects of Psilocybin on Social Connectedness

This Phase I, randomised, triple-blind, placebo-controlled trial (n=51) will study a single 25 mg dose of psilocybin in medically healthy adults aged 21 to 65 years who report high loneliness or unresolved grief symptoms, with the aim of assessing whether psilocybin reduces loneliness and improves social connectedness. The study is designed as a mechanistic trial and will also evaluate whether early changes in neural responses to social information processing predict later improvements in these outcomes. Participants will be allocated to psilocybin 25 mg or a placebo capsule in a parallel design. The trial will examine amygdala reactivity to negative socioemotional stimuli during the Facial Emotion Recognition Task, along with dorsal anterior cingulate and insula activity during social rejection using fMRI. Primary outcomes include loneliness and social connectedness measured from baseline to Day +7 and Day +30, with fMRI assessments at baseline and Day +7.

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Target Enrollment
51 participants
Study Type
Phase I interventional
Design
Randomized, triple Blind

Detailed Description

The study is a randomized, double-blind, placebo-controlled, expectancy-controlled, mechanistic trial. This study looks to explore whether a single dose of psilocybin (25mg) reduces amygdala reactivity to negative socioemotional stimuli during the Facial Emotion Recognition Task (FERT) compared to a placebo in adults who feel lonely or those with unresolved grief symptoms.

Study Arms & Interventions

Placebo

inactive

Capsule

Interventions

  • Placebo
    • single dose• 1 doses total

Psilocybin

experimental

25 mg

Interventions

  • Psilocybin25 mg
    • single dose• 1 doses total

Participants

Ages
21 – 65
Sexes
Male & Female

Inclusion Criteria

  • Medically healthy
  • Ability to provide consent
  • High loneliness defined by the UCLA-3 Loneliness Scale
  • Willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria

  • Any unstable medical condition, psychiatric disorder, or circumstance that, in the opinion of the investigator, could compromise participant safety, interfere with study participation, or hinder the participant's ability to comply with study procedures and requirements
  • Positive pregnancy test or women who are breastfeeding
  • Any contraindication to MRI such as a pacemaker or metal implants

Study Protocol, Arms & Participants

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Study Details

Study Team

Sponsors & Collaborators

Locations

Connecticut Mental Health Center — New Haven, Connecticut, United States

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