Exploring low doses of psilocybin for treating demoralization
Exploratory Study of the Effects of Low-Dose Psilocybin on Sensory Processing, Neurophysiological Arousal, and Emotional Health
This study is testing if small doses of psilocybin can help adults aged 25 to 65 who feel very hopeless feel better.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 25 Years to 65 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT05227742 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility and initial efficacy of microdoses of psilocybin in treating moderate to severe demoralization, characterized by feelings of hopelessness. Participants aged 25 to 65 will undergo a screening process, followed by a baseline intake appointment and psychoeducational orientation. They will then be randomized to receive varying doses of psilocybin or a placebo over five weekly sessions, with assessments conducted to monitor effects and safety.
Who should consider this trial
Good fit: Ideal candidates are adults aged 25 to 65 who score above 8 on the Demoralization Scale-II and are in good general health.
Not a fit: Patients under 25 or over 65, pregnant or breastfeeding women, and those with certain medical conditions or on specific medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel treatment option for individuals experiencing significant feelings of hopelessness and demoralization.
How similar studies have performed: While the use of psilocybin in higher doses has been studied, the specific approach of microdosing for demoralization is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Ability to read and write in English 2. Between 25 and 65 years old 3. Demoralization Scale-II (DS-II) score of \> 8 4. No prior hallucinogen use or it would have been 3 years since the last use of a hallucinogen 5. Availability of a friend, family member, or other form of transportation (e.g., Uber) to drive participants home after their drug administration sessions 6. In good general health as assessed by detailed medical history interview and physical examination Exclusion Criteria: 1. 24 years of age or younger; 66 years of age or older 2. Women who are pregnant (pregnancy status confirmed via urine pregnancy test) or breastfeeding 3. Current hypertension (exceeding 140 systolic and/or 90 diastolic at resting) 4. 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) 5. Personal or family history (first or second degree relatives) of psychotic or bipolar I or II disorders 6. 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). 7. History of head trauma, loss of consciousness, or neurological disease 8. Receiving treatment within the past 30 days for depression, anxiety, or substance use disorder 9. Participation within the past 30 days in a clinical trial for the treatment of depression, anxiety, or substance use disorder 10. Any current substance use disorder diagnosis (substance abstinence confirmed via urine drug screen) 11. 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 12. Any headache disorder (i.e., migraine, tension-type headache, or cluster headache) in the past year 13. Planning to move from the Birmingham area in the next 3 months
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Study coordinator: Peter S Hendricks, PhD
- Email: phendricks@uab.edu
- Phone: 205.202.1387
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.