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NCT Number: NCT07693153

The Effects of Psilocybin on Social Connectedness

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.

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Key information

Conditions

Loneliness Grief

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location contact

Anahita Bassir Nia, MD

CONTACT

[email protected]

Anahita Bassir Nia, MD

PRINCIPAL_INVESTIGATOR

About this study

The main purpose of this study is to determine whether psilocybin engages validated neural and behavioral targets associated with social information processing (SIP), specifically, amygdala threat reactivity, dorsal anterior cingulate, and insula activity during social rejection, and whether this early neural "target engagement" predicts downstream improvements in loneliness and social connectedness. By establishing these mechanistic links, this research aims to provide a data driven, experimental medicine foundation for developing effective, mechanism-based interventions to reduce loneliness.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psilocybin

Drug

25 mg

Placebo

Drug

Placebo capsule

Primary outcomes

  1. Loneliness and social connectedness

    Time frame: Baseline (Day -1) and Day +7, Day +30

    UCLA Loneliness Scale (UCLA-20)

  2. fMRI Baseline Assessments

    Time frame: Day -2, Day +7

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

Secondary outcomes

  1. Loneliness and social connectedness

    Time frame: Baseline (Day -1) and Day +7, Day +30

    Social Connectedness Scale- Revised (SCS-R)

  2. Loneliness and social connectedness

    Time frame: Baseline (Day -1) and Day +7, Day +30

    Watts Connectedness Scale (WCS)

  3. Loneliness and social connectedness

    Time frame: Baseline (Day -1), Day +7, Day +30

    PROMIS Social Isolation

  4. Loneliness and social connectedness

    Time frame: Baseline (Day -1) and Day +7, Day +30

    Berkman-Syme Social Network Index (SNI)

  5. Loneliness and social connectedness

    Time frame: Baseline (Day -1), Day +30

    The Social Network Map

  6. Loneliness and social connectedness

    Time frame: Baseline (Day -1) and Day +7, Day +30

    Multidimensional Scale of Perceived Social Support (MSPSS)

  7. Unresolved Grief Symptoms

    Time frame: Baseline (Day -1) and Day +7, Day +30

    Brief Grief Questionnaire (BGQ)

  8. Unresolved Grief Symptoms

    Time frame: Baseline (Day -1) and Day +7, Day +30

    PG-13-Revised (PG-13-R)

  9. Social-Information-Processing (SIP) Targets & Moderators

    Time frame: Baseline (Day -1) and Day +7, Day +30

    Adult Rejection Sensitivity Questionnaire (A-RSQ)

  10. Social-Information-Processing (SIP) Targets & Moderators

    Time frame: Baseline (Day -1) and Day +7, Day +30

    Yamagishi General and Close Relationship Trust Scale

  11. Social-Information-Processing (SIP) Targets & Moderators

    Time frame: Baseline (Day -1), Day +7, Day +30

    Experiences in Close Relationships-Revised (ECR-R)

  12. Social-Information-Processing (SIP) Targets & Moderators

    Time frame: Baseline (Day -1) and Day +7, Day +30

    Interpersonal Reactivity Index (IRI)

  13. fMRI baseline assessments

    Time frame: Day -2, Day +7

    Hypersensitivity to Social Rejection: Cyberball (social exclusion)

Study contacts

Contact information is provided by the study sponsor or research team.

Anahita Bassir Nia, MD

CONTACT

[email protected]

203-932-5711 ext. 1-5342

Yalda Farahmand

CONTACT

[email protected]

203-974-7427

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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