Exploratory Study of Low Dose Psilocybin

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Jan 26, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring the use of low doses of psilocybin, a natural substance found in certain mushrooms, to help people who are feeling very demoralized. Demoralization can make individuals feel hopeless and as if life has no meaning, especially during tough times like dealing with medical issues. The researchers want to see if these small doses, which don't cause the strong hallucinogenic effects that larger doses might, can help improve feelings of demoralization.

To participate, you need to be between 25 and 65 years old and have a specific score on a demoralization scale that shows you're experiencing significant feelings of hopelessness. You should be in good health, and it's important that you have someone to drive you home after the sessions, as the treatment involves taking the psilocybin in a controlled setting. However, there are several criteria that could exclude you from joining, such as being under 25 or over 65 years old, having certain health conditions, or currently using specific medications for mental health issues. If eligible, participants can expect to attend sessions where they will take the microdoses and be monitored for effects and safety.

Gender

ALL

Eligibility 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