The Effects of Psilocybin on Social Connectedness
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Psilocybin, Placebo.
- Who it may be relevant to
- Registry conditions: Loneliness, Grief. Basic parameters: 21 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug Psilocybin
25 mg - Drug Placebo
Placebo capsule
Primary outcome measures
- Loneliness and social connectedness [Time frame: Baseline (Day -1) and Day +7, Day +30]
- fMRI Baseline Assessments [Time frame: Day -2, Day +7]
Secondary outcome measures (12)
- Loneliness and social connectedness [Time frame: Baseline (Day -1) and Day +7, Day +30]
- Loneliness and social connectedness [Time frame: Baseline (Day -1) and Day +7, Day +30]
- Loneliness and social connectedness [Time frame: Baseline (Day -1), Day +7, Day +30]
- Loneliness and social connectedness [Time frame: Baseline (Day -1) and Day +7, Day +30]
- Loneliness and social connectedness [Time frame: Baseline (Day -1), Day +30]
- Loneliness and social connectedness [Time frame: Baseline (Day -1) and Day +7, Day +30]
- Unresolved Grief Symptoms [Time frame: Baseline (Day -1) and Day +7, Day +30]
- Unresolved Grief Symptoms [Time frame: Baseline (Day -1) and Day +7, Day +30]
- Social-Information-Processing (SIP) Targets & Moderators [Time frame: Baseline (Day -1) and Day +7, Day +30]
- Social-Information-Processing (SIP) Targets & Moderators [Time frame: Baseline (Day -1) and Day +7, Day +30]
- Social-Information-Processing (SIP) Targets & Moderators [Time frame: Baseline (Day -1), Day +7, Day +30]
- Social-Information-Processing (SIP) Targets & Moderators [Time frame: Baseline (Day -1) and Day +7, Day +30]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Other
Study locations
United States · 1 center
- Connecticut Mental Health Center — New Haven
Identifiers
NCT: NCT07693153 · 2000041536