What side effects are associated with this type of intervention?

Common treatments for fibromyalgia include pregabalin, gabapentin, and cyclobenzaprine. Pregabalin can cause dizziness, sedation, and weight gain. Gabapentin's side effects include dizziness, sedation, lightheadedness, and weight gain. Cyclobenzaprine may cause sedation and dizziness. Psilocybin, a serotonin receptor agonist, is being studied for its potential to reduce fibromyalgia symptoms, but its side effects can include nausea, dizziness, and transient anxiety. Patients should discuss these options and their side effects with their healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of fibromyalgia, including duloxetine (Cymbalta), milnacipran (Savella), and pregabalin (Lyrica). Duloxetine and milnacipran are serotonin-norepinephrine reuptake inhibitors (SNRIs) that increase the levels of serotonin and norepinephrine in the brain, which can help reduce pain and improve mood. Pregabalin, on the other hand, is an anticonvulsant that works by modulating calcium channels to reduce pain signaling. While these medications do not act as direct serotonin receptor agonists like psilocybin, they do influence serotonin pathways, which is a common target in the treatment of fibromyalgia.

What other types of research exist?

Promising novel alternatives to Psilocybin for fibromyalgia treatment in 2024 include pregabalin, duloxetine, milnacipran, and gabapentin. Additionally, non-pharmacological treatments such as cognitive-behavioral therapy (CBT) and meditative movement therapies have shown efficacy and may be considered.

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Psychedelic

Psilocybin for Fibromyalgia

Q: What is the mechanism of action of this treatment?

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.

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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 13 weeks for reporting.

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 • NCT02061293

Nausea

Pain

Viral upper resp. tract infection

Back pain

Bronchitis

Diarrhea

Influenza

Headache

Sinus headache

Depressed mood

Depression

Insomnia

Suicidal Ideation

Lower resp. tract congestion

Oropharyngeal pain

Alcohol withdrawal syndrome

Migraine

Thrombocytosis

Constipation

Vomiting

Oedema

Peripheral swelling

Pyrexia

Dermatitis contact

Bronchitis bacterial

Eye infection

Fungal infection

Traumatic lung injury

Hyponatremia

Arthralgia

Musculoskeletal pain

Pain in extremity

Malignant melanoma

Dizziness

Hypoesthesia

Sedation

Anger

Anxiety

Restlessness

Cough

Rhinorrhea

Sinus congestion

Sexual abuse

Endodontic procedure

Mallory-Weiss Syndrom

Anemia

Influenza like Illness

Gingivitis

Arthoscopic surgery

100%

80%

60%

40%

20%

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

~530

0 / 4Eligibility criteria met

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.