Exploratory Study of Low Dose Psilocybin

Withdrawn before enrolling · Early Phase 1 · Has a placebo group

Conditions studied: Demoralization

In brief

The purpose of the present study is to evaluate the feasibility, initial signals of efficacy, and potential mechanisms of action of "microdoses" of psilocybin (i.e., low doses of psilocybin that are not believed to produce mystical-type, transcendent, hallucinogenic, or other overtly salient subjective effects that limit functionality) in the treatment of moderate to severe demoralization (feelings of hopelessness and meaningless that frequently accompany medical illness and other life hardship).

Key facts

Study ID

NCT05227742

Run by

University of Alabama at Birmingham

People needed

0

Starts

2023-08-15

Expected to finish

2026-03-01

Last updated by the study team

2026-03-11

Who can join

Age: 25 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Ability to read and write in English
• Between 25 and 65 years old
• Demoralization Scale-II (DS-II) score of > 8
• No prior hallucinogen use or it would have been 3 years since the last use of a hallucinogen
• Availability of a friend, family member, or other form of transportation (e.g., Uber) to drive participants home after their drug administration sessions
• In good general health as assessed by detailed medical history interview and physical examination

You may not qualify if…

• 24 years of age or younger; 66 years of age or older
• Women who are pregnant (pregnancy status confirmed via urine pregnancy test) or breastfeeding
• Current hypertension (exceeding 140 systolic and/or 90 diastolic at resting)
• Use of methylphenidate or other medications for ADHD, benzodiazepines or other medications for anxiety (e.g., beta-blockers), tricyclic antidepressants, MAOIs, SSRIs, SNRIs or other medications for depression, lithium or other mood stabilizers, haloperidol or other antipsychotic medications, any medications or supplements with serotonin activity (e.g., St. John's Wort), or any other pharmacologic or biologic agent used to treat depression or anxiety (e.g., magnesium, cannabis)
• Personal or family history (first or second degree relatives) of psychotic or bipolar I or II disorders
• Any suicidal ideation of type 4 or type 5 on the Columbia Suicide Severity Rating Scale (C-SSRS) in the 3 months prior to screening (i.e., active suicidal thought with method and intent but without a specific plan, or active suicidal thought with method, intent and plan).
• History of head trauma, loss of consciousness, or neurological disease
• Receiving treatment within the past 30 days for depression, anxiety, or substance use disorder
• Participation within the past 30 days in a clinical trial for the treatment of depression, anxiety, or substance use disorder
• Any current substance use disorder diagnosis (substance abstinence confirmed via urine drug screen)
• History of immoderate alcohol consumption within the past 3 months per NIAAA definitions: more than 4 drinks per day or 14 drinks per week for men; more than 3 drinks per day or 7 drinks per week for women
• Any headache disorder (i.e., migraine, tension-type headache, or cluster headache) in the past year
• Planning to move from the Birmingham area in the next 3 months

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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