Your session is about to expire
← Back to Search
Psychedelic
Psilocybin for Fibromyalgia
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
Female age 25-65;
Widespread musculoskeletal pain for ≥12 months;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 13 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if psilocybin, a substance from certain mushrooms, can help people with fibromyalgia by reducing their pain and improving their mood. The treatment works by changing how the brain processes information and emotions. Psilocybin is a naturally occurring substance found in certain mushrooms, known for its potential therapeutic benefits for depression and anxiety.
Who is the study for?
This trial is for women aged 25-65 with chronic pain conditions like fibromyalgia, meeting specific diagnostic criteria. Participants must have had widespread musculoskeletal pain for over a year and report an average daily pain score of at least 5 out of 10. They should be able to attend all appointments, read/write in English, not have used hallucinogens recently (or at least not in the past three years), and have someone to drive them home after treatment sessions.
What is being tested?
The study is testing if psilocybin can help reduce symptoms of fibromyalgia such as pain and fatigue. It will compare the effects of psilocybin-facilitated treatment against dextromethorphan to see which one improves patients' quality of life and functioning better.
What are the potential side effects?
Psilocybin may cause psychological effects like altered perception, mood changes, or anxiety during treatment. Physical side effects could include nausea or headaches. Dextromethorphan might also lead to dizziness, sleepiness, or gastrointestinal disturbances.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman aged between 25 and 65.
Select...
I have had widespread body pain for at least 12 months.
Select...
I have been diagnosed with fibromyalgia according to the latest criteria.
Select...
My daily pain level averages at least 5 out of 10.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, up to 13 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 13 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in daily self-reported pain severity
Secondary study objectives
Change in self-reported pain interference (Brief Pain Inventory [BPI])
Change in self-reported pain severity (Brief Pain Inventory [BPI])
Patient Global Impression of Change (PGIC)
Side 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%
Diarrhea
4%
Influenza
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Depression
4%
Insomnia
4%
Suicidal Ideation
4%
Lower resp. tract congestion
4%
Oropharyngeal pain
4%
Alcohol withdrawal syndrome
2%
Migraine
2%
Thrombocytosis
2%
Constipation
2%
Vomiting
2%
Oedema
2%
Peripheral swelling
2%
Pyrexia
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Eye infection
2%
Fungal infection
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Musculoskeletal pain
2%
Pain in extremity
2%
Malignant melanoma
2%
Dizziness
2%
Hypoesthesia
2%
Sedation
2%
Anger
2%
Anxiety
2%
Restlessness
2%
Cough
2%
Rhinorrhea
2%
Sinus congestion
2%
Sexual abuse
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PsilocybinExperimental Treatment1 Intervention
Participants in the Psilocybin condition will receive .36 mg/kg of psilocybin.
Group II: Active PlaceboActive Control1 Intervention
Participants in the Active Placebo condition will receive 2.6 mg/kg of dextromethorphan (DXM).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~750
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for fibromyalgia often involve medications that modulate serotonin and norepinephrine levels, such as selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). These medications work by increasing the levels of neurotransmitters in the brain, which can help reduce pain perception and improve mood.
Tricyclic antidepressants, like amitriptyline, also increase serotonin and norepinephrine but have additional effects on other neurotransmitter systems. Cyclobenzaprine, a muscle relaxant with a tricyclic structure, is thought to improve sleep and reduce pain.
These mechanisms are crucial for fibromyalgia patients as they address both the central pain processing abnormalities and the associated mood disturbances, potentially leading to better overall symptom management.
Antidepressant therapy for unexplained symptoms and symptom syndromes.
Antidepressant therapy for unexplained symptoms and symptom syndromes.
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,640 Previous Clinical Trials
2,332,060 Total Patients Enrolled
6 Trials studying Fibromyalgia
40,312 Patients Enrolled for Fibromyalgia
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger