Grief, Loneliness
Conditions
Keywords
Social Connectedness
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.
Detailed description
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.
Interventions
DRUGPsilocybin
25 mg
DRUGPlacebo
Placebo capsule
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Loneliness and social connectedness | Baseline (Day -1) and Day +7, Day +30 | UCLA Loneliness Scale (UCLA-20) |
| fMRI Baseline Assessments | Day -2, Day +7 | Hypervigilance to Social Threat: Facial Emotion Recognition Task (FERT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Loneliness and social connectedness | Baseline (Day -1) and Day +7, Day +30 | Social Connectedness Scale- Revised (SCS-R) |
| Unresolved Grief Symptoms | Baseline (Day -1) and Day +7, Day +30 | Brief Grief Questionnaire (BGQ) |
| Social-Information-Processing (SIP) Targets & Moderators | Baseline (Day -1) and Day +7, Day +30 | Adult Rejection Sensitivity Questionnaire (A-RSQ) |
| fMRI baseline assessments | Day -2, Day +7 | Hypersensitivity to Social Rejection: Cyberball (social exclusion) |
Countries
United States
Contacts
CONTACTAnahita Bassir Nia, MD
CONTACTYalda Farahmand
PRINCIPAL_INVESTIGATORAnahita Bassir Nia, MD
Yale University
Outcome results
None listed