Health TrialsbyHealthPanel

The Effects of Psilocybin on Social Connectedness

ConditionsLonelinessGrief
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-65
SponsorYale University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Psilocybin

    Drug

    25 mg

  • Placebo

    Drug

    Placebo capsule

Treatment groups

51 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: PsilocybinActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Loneliness and social connectedness

UCLA Loneliness Scale (UCLA-20)

Time frame
Baseline (Day -1) and Day +7, Day +30
2

fMRI Baseline Assessments

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

Time frame
Day -2, Day +7

Secondary outcomes

1

Loneliness and social connectedness

Social Connectedness Scale- Revised (SCS-R)

Time frame
Baseline (Day -1) and Day +7, Day +30
2

Loneliness and social connectedness

Watts Connectedness Scale (WCS)

Time frame
Baseline (Day -1) and Day +7, Day +30
3

Loneliness and social connectedness

PROMIS Social Isolation

Time frame
Baseline (Day -1), Day +7, Day +30
4

Loneliness and social connectedness

Berkman-Syme Social Network Index (SNI)

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: