LonelinessPhase 1NCT07693153
The Effects of Psilocybin on Social Connectedness
A Phase 1 study testing Psilocybin in people with Loneliness and Grief, run by Yale University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Loneliness, Grief
- What is being tested?
- Psilocybin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2026to 15 Dec 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Connecticut Mental Health Center
New Haven, Connecticut, 06519
Anahita Bassir Nia, MD, anahita.bassirnia@yale.edu
Anahita Bassir Nia, MD
About this study
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.
Read the 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.
- Conditions
- Loneliness, Grief
- Being tested
- Psilocybin, Placebo
- Keywords
- Social Connectedness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
25 mg
PlaceboDrug
Placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Capsule Receives: Drug: Placebo |
| Psilocybin | Active comparator | 25 mg Receives: Drug: Psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loneliness and social connectedness
UCLA Loneliness Scale (UCLA-20)
Measured: Baseline (Day -1) and Day +7, Day +30
fMRI Baseline Assessments
Hypervigilance to Social Threat: Facial Emotion Recognition Task (FERT)
Measured: Day -2, Day +7
Secondary outcomes (13)
Loneliness and social connectedness
Social Connectedness Scale- Revised (SCS-R)
Measured: Baseline (Day -1) and Day +7, Day +30
Loneliness and social connectedness
Watts Connectedness Scale (WCS)
Measured: Baseline (Day -1) and Day +7, Day +30
Loneliness and social connectedness
PROMIS Social Isolation
Measured: Baseline (Day -1), Day +7, Day +30
Loneliness and social connectedness
Berkman-Syme Social Network Index (SNI)
Measured: Baseline (Day -1) and Day +7, Day +30
Loneliness and social connectedness
The Social Network Map
Measured: Baseline (Day -1), Day +30
Loneliness and social connectedness
Multidimensional Scale of Perceived Social Support (MSPSS)
Measured: Baseline (Day -1) and Day +7, Day +30
Unresolved Grief Symptoms
Brief Grief Questionnaire (BGQ)
Measured: Baseline (Day -1) and Day +7, Day +30
Unresolved Grief Symptoms
PG-13-Revised (PG-13-R)
Measured: Baseline (Day -1) and Day +7, Day +30
Social-Information-Processing (SIP) Targets & Moderators
Adult Rejection Sensitivity Questionnaire (A-RSQ)
Measured: Baseline (Day -1) and Day +7, Day +30
Social-Information-Processing (SIP) Targets & Moderators
Yamagishi General and Close Relationship Trust Scale
Measured: Baseline (Day -1) and Day +7, Day +30
Social-Information-Processing (SIP) Targets & Moderators
Experiences in Close Relationships-Revised (ECR-R)
Measured: Baseline (Day -1), Day +7, Day +30
Social-Information-Processing (SIP) Targets & Moderators
Interpersonal Reactivity Index (IRI)
Measured: Baseline (Day -1) and Day +7, Day +30
fMRI baseline assessments
Hypersensitivity to Social Rejection: Cyberball (social exclusion)
Measured: Day -2, Day +7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start31 Aug 2026 (estimated)
- Primary completion15 Dec 2031 (estimated)
- Study completion15 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LonelinessStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anahita Bassir Nia, Yale University
- Investigators
- Anahita Bassir Nia, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693153
- Sponsor's protocol ID
- 2000041536
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Psilocybin on Social Connectedness
- ClinicalTrials.gov ID
- NCT07693153
- Acronym / sponsor ID
- 2000041536
- Conditions
- Loneliness, Grief
- Keywords
- Social Connectedness
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 15 Dec 2031 (estimated)
- Study completion
- 15 Dec 2031 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboCapsule |
| Psilocybin | Active comparator | Drug: Psilocybin25 mg |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psilocybin25 mg | Drug | Psilocybin |
| PlaceboPlacebo capsule | Drug | Placebo |
Primary outcome
Loneliness and social connectedness
Time frame: Baseline (Day -1) and Day +7, Day +30
UCLA Loneliness Scale (UCLA-20)
fMRI Baseline Assessments
Time frame: Day -2, Day +7
Hypervigilance to Social Threat: Facial Emotion Recognition Task (FERT)
13 secondary outcomes
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
fMRI baseline assessments
Time frame: Day -2, Day +7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Loneliness
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Hangeoreum: A Self-Paced Web-Based Program for Loneliness and Connectedness Among Korean Immigrants Aged 50 and Older
Loneliness, Korean
Not yet recruiting
Interpersonal Relational Role Analysis Group Therapy for Nursing Students at Risk of Internet Addiction
Internet Addiction
Active, not recruiting
PREWELL Digital Well-being Promotion Intervention With the BitHabit App
General Mental Health and Well-Being, Mental Disorders
Recruiting
Intergenerational Interaction Program for Nursing Home Residents and Nursing Students
Ageism, Loneliness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anahita Bassir Nia, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Psilocybin in people with Loneliness and Grief, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anahita Bassir Nia, MD (203-932-5711 ext. 1-5342, anahita.bassirnia@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loneliness and social connectedness (time frame: Baseline (Day -1) and Day +7, Day +30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.