RECRUITING

Exploratory Study of Low Dose Psilocybin

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Exploratory Study of the Effects of Low-Dose Psilocybin on Sensory Processing, Neurophysiological Arousal, and Emotional Health

Quick Facts

Study Start:2023-08-15

Study Completion:2024-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05227742

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Peter S Hendricks, PhD

CONTACT

205.202.1387

phendricks@uab.edu

Study Locations (Sites)

University of Alabama at Birmingham

Birmingham, Alabama, 35209

United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-15

Study Completion Date2024-12

Study Record Updates

Study Start Date2023-08-15

Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

Psilocybin
Low dose
Demoralization

Additional Relevant MeSH Terms

Demoralization