The Effects of Psilocybin on Social Connectedness

NCT07693153 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 2000041536
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Loneliness; Grief

Keywords

Social Connectedness

Outcome Measures

Primary Outcomes (2)

• Loneliness and social connectedness

  UCLA Loneliness Scale (UCLA-20)

  Baseline (Day -1) and Day +7, Day +30

• fMRI Baseline Assessments

  Hypervigilance to Social Threat: Facial Emotion Recognition Task (FERT)

  Day -2, Day +7

Secondary Outcomes (13)

• Loneliness and social connectedness

  Baseline (Day -1) and Day +7, Day +30

• Loneliness and social connectedness

  Baseline (Day -1) and Day +7, Day +30

• Loneliness and social connectedness

  Baseline (Day -1), Day +7, Day +30

• Loneliness and social connectedness

  Baseline (Day -1) and Day +7, Day +30

• Loneliness and social connectedness

  Baseline (Day -1), Day +30

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Capsule

Drug: Placebo

Psilocybin

ACTIVE COMPARATOR

25 mg

Drug: Psilocybin

Interventions

Psilocybin DRUG

25 mg

Psilocybin

Placebo DRUG

Placebo capsule

Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Interventions

Psilocybin

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Anahita Bassir Nia, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anahita Bassir Nia, MD

CONTACT

203-932-5711; anahita.bassirnia@yale.edu

Yalda Farahmand

CONTACT

203-974-7427; yalda.farahmand@yale.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 9, 2026
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): December 15, 2031
• Study Completion (Estimated): December 15, 2031
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)