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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
51
25 mg
Placebo capsule
Connecticut Mental Health Center
New Haven, Connecticut, United States
Loneliness and social connectedness
UCLA Loneliness Scale (UCLA-20)
Time frame: Baseline (Day -1) and Day +7, Day +30
fMRI Baseline Assessments
Hypervigilance to Social Threat: Facial Emotion Recognition Task (FERT)
Time frame: Day -2, Day +7
Loneliness and social connectedness
Social Connectedness Scale- Revised (SCS-R)
Time frame: Baseline (Day -1) and Day +7, Day +30
Loneliness and social connectedness
Watts Connectedness Scale (WCS)
Time frame: Baseline (Day -1) and Day +7, Day +30
Loneliness and social connectedness
PROMIS Social Isolation
Time frame: Baseline (Day -1), Day +7, Day +30
Loneliness and social connectedness
Berkman-Syme Social Network Index (SNI)
Time frame: Baseline (Day -1) and Day +7, Day +30
Loneliness and social connectedness
The Social Network Map
Time frame: Baseline (Day -1), Day +30
Loneliness and social connectedness
Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: Baseline (Day -1) and Day +7, Day +30
Unresolved Grief Symptoms
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Brief Grief Questionnaire (BGQ)
Time frame: Baseline (Day -1) and Day +7, Day +30
Unresolved Grief Symptoms
PG-13-Revised (PG-13-R)
Time frame: Baseline (Day -1) and Day +7, Day +30
Social-Information-Processing (SIP) Targets & Moderators
Adult Rejection Sensitivity Questionnaire (A-RSQ)
Time frame: Baseline (Day -1) and Day +7, Day +30
Social-Information-Processing (SIP) Targets & Moderators
Yamagishi General and Close Relationship Trust Scale
Time frame: Baseline (Day -1) and Day +7, Day +30
Social-Information-Processing (SIP) Targets & Moderators
Experiences in Close Relationships-Revised (ECR-R)
Time frame: Baseline (Day -1), Day +7, Day +30
Social-Information-Processing (SIP) Targets & Moderators
Interpersonal Reactivity Index (IRI)
Time frame: Baseline (Day -1) and Day +7, Day +30
fMRI baseline assessments
Hypersensitivity to Social Rejection: Cyberball (social exclusion)
Time frame: Day -2, Day +7