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Psychedelic
Psilocybin-Induced Psychedelic Experiences During Sleep (CoPE Pilot Trial)
Phase 1
Waitlist Available
Led By Charles Raison, MD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 19 days
Awards & highlights
CoPE Pilot Trial Summary
This trial aims to safely administer psychedelic drugs while asleep to induce a psychedelic experience.
Who is the study for?
This trial is for medically healthy, English-speaking individuals. It's not suitable for those on medications that interact with psilocybin, have sleep disorders like insomnia or apnea, are pregnant women at any point during the study, or have a history of heart transplant or stroke.Check my eligibility
What is being tested?
The study tests intravenous (IV) psilocybin administration in sleeping participants to find a dose that doesn't wake them and to see if it induces psychedelic experiences. A saline solution is used as a comparison.See study design
What are the potential side effects?
While the specific side effects aren't listed here, psilocybin can typically cause changes in perception, mood swings, nausea, and an increase in heart rate and blood pressure among other potential reactions.
CoPE Pilot Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 19 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 19 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number and nature of adverse events associated with the administration of a single dose of IV psilocybin while asleep or awake
Secondary outcome measures
Percentage of subjects administered IV psilocybin while asleep who remain asleep for at least 1 hour post dosing
Post-dosing scores on the 30-item Mystical Experiences Questionnaire (MEQ30) following administration of IV psilocybin while asleep or awake
Post-dosing scores on the Altered States of Consciousness Questionnaire (ASC) following administration of IV psilocybin while asleep or awake
+7 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%
Rhinorrhea
2%
Pyrexia
2%
Hypoesthesia
2%
Oedema
2%
Vomiting
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
CoPE Pilot Trial Design
4Treatment groups
Experimental Treatment
Group I: 2-minute IV Psilocybin/Placebo Infusion - AwakeExperimental Treatment1 Intervention
Participants will receive either 2mg of IV psilocybin or 10 mL of IV saline (placebo) over 2 minutes during an overnight visit while awake.
Group II: 2-minute IV Psilocybin/Placebo Infusion - AsleepExperimental Treatment1 Intervention
Participants will receive 2mg of IV psilocybin over 2 minutes while asleep during an overnight visit and 10 mL of placebo (saline) over 2 minutes while asleep during another overnight visit. The order of administration will be determined by the study protocol.
Group III: 10-minute IV Psilocybin/Placebo Infusion - AwakeExperimental Treatment1 Intervention
Participants will receive either 2mg of IV psilocybin or 10 mL of IV saline (placebo) over 10 minutes during an overnight visit while awake.
Group IV: 10-minute IV Psilocybin/Placebo Infusion - AsleepExperimental Treatment1 Intervention
Participants will receive 2mg of IV psilocybin over 10 minutes while asleep during an overnight visit and 10 mL of placebo (saline) over 10 minutes while asleep during another overnight visit. The order of administration will be determined by the study protocol.
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Usona InstituteOTHER
12 Previous Clinical Trials
743 Total Patients Enrolled
Tiny Blue Dot FoundationUNKNOWN
4 Previous Clinical Trials
376 Total Patients Enrolled
1 Trials studying Psychedelic Experiences
108 Patients Enrolled for Psychedelic Experiences
University of Wisconsin, MadisonLead Sponsor
1,189 Previous Clinical Trials
3,169,516 Total Patients Enrolled
2 Trials studying Psychedelic Experiences
116 Patients Enrolled for Psychedelic Experiences
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant.I have a heart valve problem.I have a sleep disorder such as insomnia, sleep apnea, restless legs syndrome, or narcolepsy.I am taking medication that could interact with psilocybin.
Research Study Groups:
This trial has the following groups:- Group 1: 2-minute IV Psilocybin/Placebo Infusion - Asleep
- Group 2: 2-minute IV Psilocybin/Placebo Infusion - Awake
- Group 3: 10-minute IV Psilocybin/Placebo Infusion - Awake
- Group 4: 10-minute IV Psilocybin/Placebo Infusion - Asleep
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Which individuals are being considered for enrollment in this trial?
"Applicants to this medical trial must conform to the requirements of healthy subjects (hs) and be within the 18-40 age bracket. The team is currently recruiting approximately 15 individuals."
Answered by AI
Has this particular therapy been given regulatory approval by the FDA?
"Due to the Phase 1 nature of this trial, our team at Power judged its safety rating a 1 due to the limited evidence that exists concerning efficacy and safety."
Answered by AI
Is eligibility for the trial contingent on being over eighteen years old?
"The age requirement for this trial is 18 to 40. Separately, there are 81 clinical trials open to patients below the age of majority and 462 specifically designed for those 65 years or older."
Answered by AI
Are participants still invited to join this experiment?
"Reports on clinicaltrials.gov suggest that this trial, which was first posted March 1st 2023 and most recently edited November 3rd 2022, is no longer seeking participants; however, there are 986 other medical studies recruiting now."
Answered by AI
Who else is applying?
What site did they apply to?
University of Wisconsin Hospital and Clinics
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Why did patients apply to this trial?
I feel like this could be interesting research for mental health reasons. I’ve been wanting to try psychedelics to see if they might help my PTSD from childhood. I want to do it in a clinical setting and not in a field at a festival. :).
PatientReceived 1 prior treatment
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