FibromyalgiaPsiloFMNCT06368492
The Impact of Psilocybin on Pain in Fibromyalgia Patients
A study testing Psilocybin and Hypnosis script in people with Fibromyalgia, run by Maastricht University at 2 sites in Netherlands.
Trial summary
Rationale: Recent evidence shows that Lysergic Acid Diethylamide (LSD), even when administered in low, non-hallucinogenic doses, can produce analgesic effects and improve pain tolerance in a sample of healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Psilocybin and Hypnosis script
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesNetherlands
- Study dates
- 3 May 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- Normal weight, body mass index (weight/height2) between 18 and 28 kg/m2
- Fulfilment of the American College of Rheumatology criteria for FM diagnosis (43)
- A minimum Numeric Rating Scale (numeric rating scale) pain score of 5 out of 10
- Proficient knowledge of the Dutch or English language
- Written Informed Consent
Show all 11Show fewer
- Understanding the procedures and the risks associated with the study
- No regular use of psychotropic medication such as opiates, antidepressants, muscle relaxants, anticonvulsants, sleep aids, benzodiazepines. Non pharmacological regimens will be allowed along 1 rescue therapy such as acetaminophen ≤4,000 mg/day, ibuprofen ≤1,200 mg/day, naproxen ≤660 mg/day, or ketoprofen ≤75 mg/day. Use of paracetamol (PCM) and non-steroidal anti-inflammatory drugs (NSAIDS) will be allowed and monitored.
- Willingness to refrain from taking psychoactive substances during the study.
- Willingness to drink only alcohol-free liquids and no coffee, black or green tea, or energy drinks after midnight of the evening before the study session, as well as during the study days
- Willingness not to drive a traffic vehicle or to operate machines within 24 h after substance administration
Who cannot join
- Presence of any other painful condition such as inflammatory rheumatic diseases, migraines or headaches and of other chronic or acute medical conditions
- Presence or history of any other psychiatric condition such as primary major depressive disorder, anxiety disorders or substance use disorder as determined by the medical questionnaire, drug questionnaire and medical examination
- Previous experience of serious side effects to psychedelic drugs (anxiety or panic attacks)
- Tobacco smoking (>20 per day)
- Excessive drinking (>20 alcoholic consumptions per week)
- Psychotic disorder in first-degree relatives
Show all 10Show fewer
- Pregnancy or lactation
- Hypertension (diastolic > 90 mmHg; systolic > 140 mmHg)
- History of cardiac dysfunctions (arrhythmia, ischemic heart disease…)
- For women: no use of a reliable contraceptive
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Recruiting
Leiden University Medical Center
Leiden, South Holland, 2333
Monique van Velzen, PhD, M.van_Velzen@lumc.nl
- Recruiting
Maastricht University
Maastricht, Limburg, 6226AK
Mauro Cavarra, MSc, +313494438261, m.cavarra@maastrichtuniversity.nl
About this study
Official title: The Impact of Psilocybin on Pain in Fibromyalgia Patients: a Multicentre Trial.
Rationale: Recent evidence shows that Lysergic Acid Diethylamide (LSD), even when administered in low, non-hallucinogenic doses, can produce analgesic effects and improve pain tolerance in a sample of healthy volunteers. Such results complement what was already observed with other serotonergic psychedelics such as psilocybin: survey studies and case series indicate that its use may lead to improvements in chronic pain conditions such as migraines, cluster headaches and phantom limb pain even at low, non-psychedelic doses. These effects have however not yet been investigated and confirmed in clinical populations under controlled experimental conditions.
Fibromyalgia (FM) is a chronic condition characterised by widespread pain, hyperalgesia, anxiety, disturbed sleep patterns, impaired cognitive functioning and comorbid mood disorders. Most suggested therapies are only associated with small improvements in pain ratings and quality of life. Currently, there is no data concerning the effectiveness of serotonergic psychedelics in improving pain ratings in fibromyalgia patients.
Read more
Objective: The present study will explore the effects that the administration of a placebo and 2 low psilocybin doses (5 mg or 10 mg) will have on pain perception in a group of fibromyalgia patients.
Study design: The present study uses a double-blind, randomized, placebo-controlled design. All participants will receive a placebo and 2 doses of psilocybin (5 mg or 10 mg) and will undergo the Cold Pressor Test (CPT) and the Pain Pressure Threshold Task (PPT) o test its analgesic effects.
Read the detailed description
Rationale: Recent evidence shows that Lysergic Acid Diethylamide (LSD), even when administered in low, non-hallucinogenic doses, can produce analgesic effects and improve pain tolerance in a sample of healthy volunteers. Such results complement what was already observed with other serotonergic psychedelics such as psilocybin: survey studies and case series indicate that its use may lead to improvements in chronic pain conditions such as migraines, cluster headaches and phantom limb pain even at low, non-psychedelic doses. These effects have however not yet been investigated and confirmed in clinical populations under controlled experimental conditions.
Fibromyalgia (FM) is a chronic condition characterised by widespread pain, hyperalgesia, anxiety, disturbed sleep patterns, impaired cognitive functioning and comorbid mood disorders. It has high direct and indirect costs and it is considered challenging to treat. Most suggested therapies, in fact, are only associated with small improvements in pain ratings and quality of life. Currently, there is no data concerning the effectiveness of serotonergic psychedelics in improving pain ratings in fibromyalgia patients.
Objective: The present study will explore the effects that the administration of a placebo and 2 low psilocybin doses (5 mg or 10 mg) will have on pain perception in a group of fibromyalgia patients.
Study design: The present study uses a double-blind, randomized, placebo-controlled design. All participants will receive a placebo and 2 doses of psilocybin (5 mg or 10 mg) and will undergo the Cold Pressor Test (CPT) and the Pain Pressure Threshold Task (PPT) o test its analgesic effects.
Study population: 35 fibromyalgia patients aged 18 to 65 years. Intervention: Placebo, 5 mg or 10 mg of psilocybin in randomized order. Main study parameters/endpoints: Primary outcomes will be subjective and objective measures of pain perception. Secondary measures will assess the effects that placebo and psilocybin will have on mood, cognition and psychedelic experience. Finally, participants will take part to an additional CPT after receiving hypnotic suggestions of analgesia to test whether such intervention may moderate pain ratings of individuals who took small doses of psilocybin.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants will visit the research lab 5 times during 5 weeks. Before the first study day, subjects will come for a screening visit during which they will also be familiarized with tests and study procedures. This includes a medical screening by a licensed physician (medical history review, laboratory screening, electrocardiogram recording). The study visits will consist of taking the study treatment (5 mg or 10 mg of psilocybin or placebo), taking part to the experimental tasks, taking blood samples, completing computer tasks and filling out questionnaires. Finally, participants will take part to a final online visit to administer post-study questionnaires.
- Conditions
- Fibromyalgia
- Being tested
- Psilocybin, Hypnosis script
- Keywords
- fibromyalgia, psychedelics, psilocybin, chronic pain
- Medical subject headings
- Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
Each participant will receive 2 different doses of psilocybin (5mg and 10mg) and a matching placebo on three separate occasions.
Hypnosis scriptBehavioural
All participants will receive a brief hypnotic induction aimed at producing analgesia before the second administration of CPT
| Study group | Role | What they receive |
|---|---|---|
| Patient group | Experimental | Each participant will receive 2 different doses of psilocybin (5mg and 10mg) and a matching placebo on three separate occasions. Receives: Drug: Psilocybin; Behavioral: Hypnosis script |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ischemic Pain perception
Pain tolerance (seconds) in the Cold Pressor Task
Measured: 1.5, 2.5 and 4 hours after administration
Pressure-evoked Pain perception
Pain threshold (kPa) in the Pressure Pain Threshold
Measured: 1.5 and 4 hours after administration
Self-reported pain
Painfulness Visual Analogue Scale (0: no pain; 10 worst pain)
Measured: 1.5, 2.5 and 4 hours after administration
Secondary outcomes (20)
Subjective effects: psychedelic phenomenology
5 Dimensions of altered states of consciousness (5D-ASC)
Measured: Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5 and 6 hours after administration
Subjective effects: mood
Profile of mood states (POMS)
Measured: Baseline, 1, 2, 3, and 5 hours after administration
Subjective effects: intensity of effects
Intensity of effects Visual Analogue Scale (VAS) (0: not under the influence; 10: very much under the influence)
Measured: Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5 and 6 hours after administration
Subjective effects: Ego dissolution
Ego Dissolution Inventory(EDI)
Measured: 6 hours after administration
Subjective effects: Dissociation
Clinical Administered Dissociative States Scale (CADSS)
Measured: Baseline and 6 hours after administration
Psychiatric symptoms
Brief Symptom Inventory (BSI)
Measured: Baseline and 6 hours after administration
Cognitive performance
Digit Symbol Substitution Test (DSST) - time to complete in seconds and number of errors
Measured: 1.5 and 4 hours after administration
Vigilance
Psychomotor Vigilance Task (PVT) - number of attention lapses
Measured: 1.5 and 4 hours after administration
Empathy
Multifaceted Empathy Test (MET) - emotion recognition accuracy (right answers/wrong answers)
Measured: 1 hour after administration
Creativity
Alternate Use Test (AUT) - Fluency and Originality, Flexibility, and Elaboration scores
Measured: 2.5 hours after administration
Creativity
Story Writing
Measured: 2 hours after administration
Autobiographical memory
Autobiographical Memory Test (AMT)
Measured: 2.5 hours after administration
Autobiographical memory
Autobiographical Recollection Test (ART)
Measured: Study baseline and 1 week after last experimental session
Treatment expectancy
Credibility/Expectancy Questionnaire (CEQ)
Measured: Study baseline
Treatment expectancy
Treatment Expectations in Chronic Pain (TEC)
Measured: Study baseline
Fibromyalgia-related pain
- Fibromyalgia Impact Questionnaire (FIQ)
Measured: Baseline and 1 week after each experimental session
Personality
Big Five Inventory (BFI)
Measured: Baseline and 1 week after last experimental session
Absorption
Modified Tellegen Absorption Scale (MODTAS)
Measured: Baseline and 1 week after the experimental session
Interpersonal Reactivity
Interpersonal Reactivity Index (IRI)
Measured: Baseline and 1 week after last experimental session
Depression
- Beck Depression Inventory - II (BDI-II)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start3 May 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- double-blind, randomized, within-subjects, placebo-controlled design.
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center
- Responsible party
- Sponsor
- Investigators
- Johannes G. Ramaekers, PhD, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368492
- Sponsor's protocol ID
- P137
- Other IDs
- 2021-002909-10, NL78008.068.21
- Acronym
- PsiloFM
- Status last verified
- Sep 2025
- First submitted
- 31 Oct 2023
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Castellanos JP, Woolley C, Bruno KA, Zeidan F, Halberstadt A, Furnish T. Chronic pain and psychedelics: a review and proposed mechanism of action. Reg Anesth Pain Med. 2020 Jul;45(7):486-494. doi: 10.1136/rapm-2020-101273. Epub 2020 May 4.
PubMed 32371500
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Psilocybin on Pain in Fibromyalgia Patients: a Multicentre Trial.
- ClinicalTrials.gov ID
- NCT06368492
- Acronym / sponsor ID
- PsiloFM / P137
- Conditions
- Fibromyalgia
- Keywords
- fibromyalgia, psychedelics, psilocybin, chronic pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Collaborators
- Leiden University Medical Center
- Study start
- 3 May 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: Recent evidence shows that Lysergic Acid Diethylamide (LSD), even when administered in low, non-hallucinogenic doses, can produce analgesic effects and improve pain tolerance in a sample of healthy volunteers. Such results complement what was already observed with other serotonergic psychedelics such as psilocybin: survey studies and case series indicate that its use may lead to improvements in chronic pain conditions such as migraines, cluster headaches and phantom limb pain even at low, non-psychedelic doses. These effects have however not yet been investigated and confirmed in clinical populations under controlled experimental conditions.
Fibromyalgia (FM) is a chronic condition characterised by widespread pain, hyperalgesia, anxiety, disturbed sleep patterns, impaired cognitive functioning and comorbid mood disorders. Most suggested therapies are only associated with small improvements in pain ratings and quality of life. Currently, there is no data concerning the effectiveness of serotonergic psychedelics in improving pain ratings in fibromyalgia patients.
Objective: The present study will explore the effects that the administration of a placebo and 2 low psilocybin doses (5 mg or 10 mg) will have on pain perception in a group of fibromyalgia patients.
Study design: The present study uses a double-blind, randomized, placebo-controlled design. All participants will receive a placebo and 2 doses of psilocybin (5 mg or 10 mg) and will undergo the Cold Pressor Test (CPT) and the Pain Pressure Threshold Task (PPT) o test its analgesic effects.
Detailed description
Rationale: Recent evidence shows that Lysergic Acid Diethylamide (LSD), even when administered in low, non-hallucinogenic doses, can produce analgesic effects and improve pain tolerance in a sample of healthy volunteers. Such results complement what was already observed with other serotonergic psychedelics such as psilocybin: survey studies and case series indicate that its use may lead to improvements in chronic pain conditions such as migraines, cluster headaches and phantom limb pain even at low, non-psychedelic doses. These effects have however not yet been investigated and confirmed in clinical populations under controlled experimental conditions.
Fibromyalgia (FM) is a chronic condition characterised by widespread pain, hyperalgesia, anxiety, disturbed sleep patterns, impaired cognitive functioning and comorbid mood disorders. It has high direct and indirect costs and it is considered challenging to treat. Most suggested therapies, in fact, are only associated with small improvements in pain ratings and quality of life. Currently, there is no data concerning the effectiveness of serotonergic psychedelics in improving pain ratings in fibromyalgia patients.
Objective: The present study will explore the effects that the administration of a placebo and 2 low psilocybin doses (5 mg or 10 mg) will have on pain perception in a group of fibromyalgia patients.
Study design: The present study uses a double-blind, randomized, placebo-controlled design. All participants will receive a placebo and 2 doses of psilocybin (5 mg or 10 mg) and will undergo the Cold Pressor Test (CPT) and the Pain Pressure Threshold Task (PPT) o test its analgesic effects.
Study population: 35 fibromyalgia patients aged 18 to 65 years. Intervention: Placebo, 5 mg or 10 mg of psilocybin in randomized order. Main study parameters/endpoints: Primary outcomes will be subjective and objective measures of pain perception. Secondary measures will assess the effects that placebo and psilocybin will have on mood, cognition and psychedelic experience. Finally, participants will take part to an additional CPT after receiving hypnotic suggestions of analgesia to test whether such intervention may moderate pain ratings of individuals who took small doses of psilocybin.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants will visit the research lab 5 times during 5 weeks. Before the first study day, subjects will come for a screening visit during which they will also be familiarized with tests and study procedures. This includes a medical screening by a licensed physician (medical history review, laboratory screening, electrocardiogram recording). The study visits will consist of taking the study treatment (5 mg or 10 mg of psilocybin or placebo), taking part to the experimental tasks, taking blood samples, completing computer tasks and filling out questionnaires. Finally, participants will take part to a final online visit to administer post-study questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- double-blind, randomized, within-subjects, placebo-controlled design.
| Arm | Type | Receives |
|---|---|---|
| Patient group | Experimental | Drug: Psilocybin, Behavioral: Hypnosis scriptEach participant will receive 2 different doses of psilocybin (5mg and 10mg) and a matching placebo on three separate occasions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age between 18 and 65 years
- Normal weight, body mass index (weight/height2) between 18 and 28 kg/m2
- Fulfilment of the American College of Rheumatology criteria for FM diagnosis (43)
- A minimum Numeric Rating Scale (numeric rating scale) pain score of 5 out of 10
- Proficient knowledge of the Dutch or English language
Key exclusion criteria (10 listed)
- Presence of any other painful condition such as inflammatory rheumatic diseases, migraines or headaches and of other chronic or acute medical conditions
- Presence or history of any other psychiatric condition such as primary major depressive disorder, anxiety disorders or substance use disorder as determined by the medical questionnaire, drug questionnaire and medical examination
- Previous experience of serious side effects to psychedelic drugs (anxiety or panic attacks)
- Tobacco smoking (>20 per day)
- Excessive drinking (>20 alcoholic consumptions per week)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsilocybinEach participant will receive 2 different doses of psilocybin (5mg and 10mg) and a matching placebo on three separate occasions. | Drug | Patient group |
| Hypnosis scriptAll participants will receive a brief hypnotic induction aimed at producing analgesia before the second administration of CPT | Behavioural | Patient group |
Primary outcome
Ischemic Pain perception
Time frame: 1.5, 2.5 and 4 hours after administration
Pain tolerance (seconds) in the Cold Pressor Task
Pressure-evoked Pain perception
Time frame: 1.5 and 4 hours after administration
Pain threshold (kPa) in the Pressure Pain Threshold
Self-reported pain
Time frame: 1.5, 2.5 and 4 hours after administration
Painfulness Visual Analogue Scale (0: no pain; 10 worst pain)
20 secondary outcomes
Subjective effects: psychedelic phenomenology
Time frame: Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5 and 6 hours after administration
Subjective effects: mood
Time frame: Baseline, 1, 2, 3, and 5 hours after administration
Subjective effects: intensity of effects
Time frame: Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5 and 6 hours after administration
Subjective effects: Ego dissolution
Time frame: 6 hours after administration
Subjective effects: Dissociation
Time frame: Baseline and 6 hours after administration
Psychiatric symptoms
Time frame: Baseline and 6 hours after administration
Cognitive performance
Time frame: 1.5 and 4 hours after administration
Vigilance
Time frame: 1.5 and 4 hours after administration
Empathy
Time frame: 1 hour after administration
Creativity
Time frame: 2.5 hours after administration
Creativity
Time frame: 2 hours after administration
Autobiographical memory
Time frame: 2.5 hours after administration
Autobiographical memory
Time frame: Study baseline and 1 week after last experimental session
Treatment expectancy
Time frame: Study baseline
Treatment expectancy
Time frame: Study baseline
Fibromyalgia-related pain
Time frame: Baseline and 1 week after each experimental session
Personality
Time frame: Baseline and 1 week after last experimental session
Absorption
Time frame: Baseline and 1 week after the experimental session
Interpersonal Reactivity
Time frame: Baseline and 1 week after last experimental session
Depression
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Background: PubMed 32371500Castellanos JP, Woolley C, Bruno KA, Zeidan F, Halberstadt A, Furnish T. Chronic pain and psychedelics: a review and proposed mechanism of action. Reg Anesth Pain Med. 2020 Jul;45(7):486-494. doi: 10.1136/rapm-2020-101273. Epub 2020 May 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Johannes G. Ramaekers, PhD principal investigator
Maastricht University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psilocybin and Hypnosis script in people with Fibromyalgia, run by Maastricht University at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mauro Cavarra, MSc (+310683029784, fpn-pim_p137@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ischemic Pain perception (time frame: 1.5, 2.5 and 4 hours after administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06368492, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.