Health TrialsbyHealthPanel

Psilocybin for Prolonged Grief Disorder

ConditionProlonged Grief Disorder
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Virginia

About this trial

The primary purpose of this study is to explore the feasibility of conducting a clinical trial on the effects of psilocybin for individuals with prolonged grief disorder (PGD).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Ages 18 years old up to and including 65 years of age

Negative UDS results for illicit drugs at screening and prior to each drug administration session

Consent to all study procedures

Have an existing diagnosis of Prolonged Grief Disorder. May also be determined to have Complicated Grief Disorder without official diagnosis as determined by PI or designate based on DSM V criteria

Disqualifiers

Previous use of a psychedelic drug may be exclusionary depending on frequency, context, and participant safety as determined by the PI or designate.

Person who is pregnant, nursing, or planning to get pregnant determined at screening and before drug session by urine test or self-report

People of childbearing potential that are sexually active who are not practicing an effective means of birth control

Cardiovascular conditions: coronary artery disease, stroke, angina, a clinically significant ECG abnormality (e.g., atrial fibrillation), prolonged QTc interval (i.e., QTc > 450 msec), heart valve, or TIA in the past year.

Trial design

Design model

Single group

Treatments tested in this trial

  • Psilocybin 25 mg

    Drug

    25 mg psilocybin administered to each participant in single arm, open-label trial

  • Functional Magnetic Resonance Imaging (fMRI)

    Diagnostic test

    There are two "fMRIs" (functional magnetic resonance imaging) that take place 1-14 days before and 1-14 days after psilocybin administration.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Open-label, single arm trialExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Recruitment Rate

Number of participants enrolled divided by number screened over the recruitment period.

Time frame
Through end of enrollment period
2

Dropout Rate

Proportion of enrolled participants who withdraw or are lost to follow-up prior to completing the 6-month assessment.

Time frame
Baseline to 6-month Follow-up

Secondary outcomes

1

Change in Prolonged Grief Disorder Symptoms (ICG)

Change in the Inventory of Complicated Grief (ICG) is a 19-item scale assessing prolonged grief symptoms. Scores range from 0 to 76, with higher scores indicating greater symptom severity.

Time frame
Baseline (Visit 0 - Screening) to 6-month Follow-up
2

Change in PTSD Symptoms (DTS)

Change in Davidson Trauma Scale (DTS) total score; range 0-136; higher scores indicate more severe PTSD symptoms.

Time frame
Baseline (Visit 0 Screening) to 6-month Follow-up
3

Mystical Experience (MEQ)

Change in Mystical Experiences Questionnaire (MEQ-30) mean score; range 0-5; higher scores indicate greater mystical-type experience.

Time frame
Baseline (Visit 3 - Treatment Visit) to 6-month Follow-up
4

Altered States of Consciousness (5-D ASC)

Change in 5-Dimensions of Altered States of Consciousness score; range 0-100%; higher percentages indicate greater altered-state intensity.

Time frame
Baseline (Visit 3 - Treatment Visit) to 6-month Follow-up

Other outcomes

Sponsors and contacts

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

University of Virginia

Lead sponsor

Tiny Blue Dot Foundation

Collaborator

Texas Tech University

Collaborator

Source ClinicalTrials.gov
Apply now