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Psychedelic
Psilocybin + Psychotherapy for Fibromyalgia
Phase 2
Recruiting
Led By Kevin F Boehnke, PhD
Research Sponsored by Kevin Boehnke
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant must be 25 to 64 years of age, inclusive, at the time of signing the informed consent form.
Females of reproductive potential must use effective birth control for the duration of active intervention.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks following the second dose
Awards & highlights
Study Summary
This trial will investigate whether psilocybin therapy can help relieve fibromyalgia symptoms when used in combination with psychotherapy.
Who is the study for?
Adults aged 25-64 with fibromyalgia for at least 3 months, stable in psychotherapy, non-smokers, and not using certain medications can join. They must avoid psychoactive substances before sessions and women of childbearing potential need effective birth control.Check my eligibility
What is being tested?
The trial tests the combination of oral psilocybin (a psychedelic compound) with psychotherapy to see if it helps reduce chronic pain in fibromyalgia patients. Participants will take psilocybin under controlled conditions alongside their ongoing therapy.See study design
What are the potential side effects?
Psilocybin may cause temporary changes in perception, mood swings, dizziness, nausea or headaches. Psychotherapy has minimal side effects but can sometimes bring up uncomfortable emotions as part of the therapeutic process.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 25 and 64 years old.
Select...
I am using effective birth control and will continue to do so during the treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks following the second dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks following the second dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To assess the safety of psilocybin under the conditions of this trial measuring Adverse Events
To assess the safety of psilocybin under the conditions of this trial measuring vital signs
Trial Design
1Treatment groups
Experimental Treatment
Group I: Open Label Oral PsilocybinExperimental Treatment2 Interventions
This is an open-label study, and participants who meet the inclusion and exclusion criteria will be eligible and invited to enroll. Enrolled participants are planned to receive 2 doses of psilocybin: a 15 mg dose followed 2 weeks later by a 25 mg dose. The total planned duration of the study for an individual participant from screening to last follow-up is approximately 8 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~730
Psychotherapy
2020
Completed Phase 3
~3120
Find a Location
Who is running the clinical trial?
Kevin BoehnkeLead Sponsor
1 Previous Clinical Trials
468 Total Patients Enrolled
TRYP TherapeuticsLead Sponsor
3 Previous Clinical Trials
24 Total Patients Enrolled
Kevin F Boehnke, PhDPrincipal InvestigatorUniversity of Michigan
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can avoid nonprescription drugs and supplements for 7 days before each psilocybin session.I am currently on antidepressant medication.My condition matches the study's required disease characteristics.I am taking diabetes medication and have had low blood sugar episodes.I can avoid alcohol, nicotine, and psychoactive drugs 24 hours before and after taking psilocybin, except for caffeine.You have a high level of alcohol in your breath or test positive for drugs like cocaine, methamphetamine, or opioids in your urine.I have epilepsy and a history of seizures.I have been in stable psychotherapy for at least 2 months.You have had a serious problem with alcohol, tobacco, or other drugs in the past.You have been diagnosed with schizophrenia, other psychotic disorders, or bipolar I or II disorder according to the DSM-5 criteria.I have diabetes that requires insulin treatment.I have been diagnosed with severe depression.I have had a heart condition in the last year.I am sexually active and not using effective birth control.You have a current autoimmune disease that is not well controlled.I will not take any 'as needed' medications on the mornings I have psilocybin sessions.I have a close relative with schizophrenia, bipolar disorder, or another psychotic disorder.I will not take Viagra, tadalafil, or similar drugs around my psilocybin treatment.I have been diagnosed with fibromyalgia for over 3 months or had symptoms for a year.I am between 25 and 64 years old.I regularly take prescribed medication for my mental health.I have been in stable psychotherapy for at least 2 months.I am medically stable as confirmed by recent health screenings and an ECG.I am at least 18 years old.You have a high risk of harming yourself based on certain criteria.I am using effective birth control and will continue to do so during the treatment.I am using birth control as per my local laws.I am currently taking medication that affects serotonin in my brain.I am using or willing to use effective birth control during the study.I have been on antidepressants for at least 2 weeks.You need to have a score of 13 or higher on the 2016 FM survey criteria.I have been diagnosed with fibromyalgia for 3 months or have had symptoms for a year.I agree not to use any mind-altering substances or alcohol 24 hours before and after each treatment, except for caffeine.
Research Study Groups:
This trial has the following groups:- Group 1: Open Label Oral Psilocybin
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.
Are there any risks associated with psychological counseling?
"Despite the absence of evidence for Psychotherapy's efficacy, there is ample data suggesting its safety and so it earned a rating of 2."
Answered by AI
Are researchers still accepting volunteers for this investigation?
"According to the information on clinicaltrials.gov, this particular medical study is no longer enrolling new patients. It was first made public on March 1st 2022 and last updated November 10th 2021; however, 129 other healthcare trials are presently open for recruitment."
Answered by AI
Are seniors being included in the sample size of this experiment?
"To participate in this trial, applicants must be between the age of 25 and 64. Seven clinical trials are available for those younger than 18, while 103 studies can accommodate seniors over 65 years old."
Answered by AI
Have there been any other investigations into the efficacy of psychotherapies?
"Right now, there are 32 ongoing clinical studies looking into psychotherapy. None of these trials have reached the advanced Phase 3 stage yet. Interestingly, Vancouver, Washington is home to most of these initiatives with a total of 35 research sites available in multiple locations."
Answered by AI
What criteria must participants meet to qualify for enrollment into this trial?
"This research is recruiting 20 individuals aged 25 to 64 with a confirmed diagnosis of fibromyalgia that have had the condition for at least 3 months or experienced symptoms for 12 months.In addition, participants must meet other criteria such as medical stability and be non-smokers (tobacco), not consume psychoactive drugs 24 hours before/after administration, and agree to maintain caffeine consumption on testing days."
Answered by AI
What is the current enrollment count for this research endeavor?
"As of November 10th 2021, this clinical trial is no longer accepting new participants. It was first advertised on March 1st 2022 and has since been edited multiple times. For those still looking for research opportunities related to fibromyalgia, there are 97 studies available with 32 trials focusing on psychotherapy."
Answered by AI
Who else is applying?
What state do they live in?
California
Illinois
Other
Michigan
How old are they?
18 - 65
What site did they apply to?
University of Michigan - Functional MRI laboratory
Chronic Pain and Fatigue Research Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I have suffered with Fibromyalgia pain for more than 4 years and I am hoping that this study could help with it.
PatientReceived 2+ prior treatments
I have fibromyalgia and I’m always curious to combine psychotherapy with adjunctive therapy of medication to help the pain spikes.
PatientReceived 2+ prior treatments
I have tried many different treatments since my 20s and I haven't been able to find relief. I'm tired, I hurt all the time, and I am losing the best years of my life.
PatientReceived 2+ prior treatments
I have been on several medications that don't seem to help much, and all have bad side effects. It is my hope that this trial will either cure me or at the very least be a springboard to finding better alternatives to chronic pain like FM, restless leg and autoimmune conditions.
PatientReceived 1 prior treatment
I have been in chronic pain without any hope of help. My joints are shot, knees elbows shoulders.
everything I do causes me discomfort. I'm losing choices everyday doing to health matters. If I don't get help soon my only option is going to be adult foster care. I'm losing ability to do anything even walking more than twenty wards without excruciating pain. I have had 2 knee replacements on same knee and still can't walk my elbows need a total replacement. I feel like me body is attacking itself I've went from working construction a year ago to sitting in a chair and struggling to do anything, I'm desperate if your trail could help me please contact me this has been a thirty year struggle at 62 I can't keep fighting when I just keep losing ability to work or I've become homeless. e-mail is pvtrock15@outlook.com phone 231-419-0268 thank you .
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How would transportation work? Is there compensation for travel? How long do visits take and what time of day?
PatientReceived no prior treatments
Does this medicine prove as a resolution to physicalized mental pain?
PatientReceived 1 prior treatment
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