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Psychedelic
Psilocybin for Demoralization
Phase < 1
Recruiting
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Between 25 and 65 years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at hour 2 of drug administration #5 at week 7
Awards & highlights
Study Summary
This trial looks into whether low doses of psilocybin could treat feelings of hopelessness and meaninglessness from medical illness and life hardship.
Who is the study for?
This trial is for English-speaking adults aged 25-65 who feel hopeless and meaningless, scoring over 8 on the Demoralization Scale-II. Participants must be in good health, have not used hallucinogens recently (or at all), can secure a ride home post-session, and are not pregnant or breastfeeding. Exclusions include recent mental health treatment, substance abuse, certain medical conditions like hypertension or neurological issues, and those taking various medications for mood disorders.Check my eligibility
What is being tested?
The study tests if low doses of psilocybin can help with feelings of demoralization without causing significant mind-altering effects. It's an exploratory study comparing the effects of 'microdoses' of psilocybin to a placebo in controlled settings.See study design
What are the potential side effects?
While microdosing aims to avoid strong side effects typical of higher doses of psilocybin such as hallucinations or transcendental experiences, potential mild side effects may include changes in mood or perception, slight nausea, headache or fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 25 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at hour 2 of drug administration #5 at week 7
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at hour 2 of drug administration #5 at week 7
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
CPT-3
Challenging Experience
Demoralization
+3 moreSide effects data
From 2021 Phase 2 trial • 95 Patients • NCT020612939%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Suicidal Ideation
4%
Oropharyngeal pain
4%
Insomnia
4%
Influenza
4%
Depression
4%
Diarrhea
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Lower resp. tract congestion
4%
Alcohol withdrawal syndrome
2%
Restlessness
2%
Fungal infection
2%
Pyrexia
2%
Hypoesthesia
2%
Oedema
2%
Vomiting
2%
Rhinorrhea
2%
Musculoskeletal pain
2%
Peripheral swelling
2%
Thrombocytosis
2%
Eye infection
2%
Constipation
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Pain in extremity
2%
Dizziness
2%
Migraine
2%
Sedation
2%
Anger
2%
Anxiety
2%
Cough
2%
Sexual abuse
2%
Sinus congestion
2%
Malignant melanoma
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: 5 mg psilocybinExperimental Treatment1 Intervention
Participants in this arm will receive 5 mg psilocybin once per week for 5 weeks.
Group II: 2.5 mg psilocybinExperimental Treatment1 Intervention
Participants in this arm will receive 2.5 mg psilocybin once per week for 5 weeks.
Group III: 1 mg psilocybinExperimental Treatment1 Intervention
Participants in this arm will receive 1 mg psilocybin once per week for 5 weeks.
Group IV: Placebo (0 mg psilocybin)Placebo Group1 Intervention
Participants in this arm will receive 0 mg of psilocybin once per week for 5 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~730
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,583 Previous Clinical Trials
2,279,984 Total Patients Enrolled
Diamond Therapeutics Inc.Industry Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant or breastfeeding.I am either 24 years old or younger, or 66 years old or older.I have someone or a way to get home after my treatment sessions.I am taking medication for ADHD, anxiety, depression, mood stabilization, or psychosis.I have not participated in a clinical trial for depression, anxiety, or substance use in the last 30 days.I have been treated for depression, anxiety, or substance use in the last 30 days.I have had a head injury, lost consciousness, or have a neurological disease.I am between 25 and 65 years old.I or my close family have a history of severe mental health issues.You have not used any hallucinogenic drugs in the past 3 years.My blood pressure is above 140/90.I have had headaches, like migraines or tension headaches, in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo (0 mg psilocybin)
- Group 2: 1 mg psilocybin
- Group 3: 2.5 mg psilocybin
- Group 4: 5 mg psilocybin
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this medical trial open to participants over the age of seventy-five?
"As stated by the study's rules, only individuals aged 25 or above and not exceeding 65 years old are eligible to enrol in this experiment."
Answered by AI
What is the estimated size of the population participating in this research?
"Confirmed. According to the information presented on clinicaltrials.gov, this medical research project is actively recruiting participants - with a first post date of August 1st 2023 and most recent edits made as recently as August 15th 2023. A total of 60 patients are needed across one site for the study."
Answered by AI
Is the enrollment process for this research still open?
"Per the clinicaltrials.gov website, this medical research is currently recruiting participants to participate in their study. The trial was initially posted on August 1st 2023 and has had a recent update by its authors on August 15th of the same year."
Answered by AI
Who meets the requirements to participate in this medical experiment?
"Candidates must be between 25 and 65 years old to take part in this medical trial, which is currently registering up to 60 participants that are exhibiting signs of demoralization."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
What site did they apply to?
University of Alabama at Birmingham
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
I am currently losing hope due to tinnitus as it has recently increased for no reason. I have read that Psilocybin could possibly help with this.
PatientReceived 2+ prior treatments
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