FibromyalgiaPsilopainNCT05548075
Psilocybin in Patients With Fibromyalgia: EEG-measured Brain Biomarkers of Action
An observational study of Fibromyalgia, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess brain activity under Psilocybin in a cohort of people with fibromyalgia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Psilocybin and Therapeutic support
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Aug 2022to 30 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Fibromyalgia lasting for more than 3 months, as diagnosed by an appropriate medical professional using the American College of Rheumatology diagnostic criteria.
Who may be able to join
- Fibromyalgia lasting for more than 3 months, as diagnosed by an appropriate medical professional using the American College of Rheumatology diagnostic criteria.
- Over 18 years of age
- United Kingdom (UK) resident registered with a primary care medical practice
- Sufficiently competent in English with capacity to provide written informed consent
- Agreement for research team to contact primary and/or secondary care team over the course of the study
- No psychedelic use in the past 6 months
Who cannot join
- Current or previously diagnosed psychotic disorder or bipolar disorder
- Immediate family member with a diagnosed psychotic disorder
- History of serious suicide attempts or presence of significant suicide/self-harm risk at screening
- Emotionally unstable personality, history of mania, or other psychiatric problem that the screening clinician feels may jeopardise the therapeutic alliance and/or safe exposure to psilocybin
- Currently using medication which could interact with psilocybin including anti-psychotics, mood stabilizers \& serotonergic antidepressants including selective serotonin reuptake inhibitors (SSRIs), SNRIs, and tricyclic antidepressants (TCAs)*
- On waiting list for interventional treatment for pain (e.g. surgery or targeted injections)
Show all 19Show fewer
- Actively enrolled on pain management programme over course of study or awaiting further investigations for pain
- Contraindications to EEG components of the study (e.g., epilepsy, migraine, focal scalp sensitivity)
- MRI contraindications (e.g. claustrophobia, metal implants)
- Physical co-morbidities that are unsuitable for the psychedelic component of the study (e.g., epilepsy, severe cardiovascular disease, insulin-dependent diabetes, hepatic or renal failure e.g., CrCl < 30ml/min etc)
- Blood or needle phobia
- Positive pregnancy test at screening or during the study
- People who are breastfeeding
- Unable to engage with physical demands of dosing session (i.e. attend centre and remain in research facility for an extended period of time)
- Unable to access virtual meetings/phone for remote follow-ups
- Patients consuming more than 35 units of alcohol per week.
- Presence of new or un-investigated 'red flag' symptom indicating need for urgent investigation (e.g. upper motor neuron syndrome, gait ataxia, bladder or bowel dysfunction).
- Limited life expectancy (<18 months) or rapidly deteriorating condition that may inhibit completion of the study (6 month remote follow up).
- Currently prescribed any of the following drugs: Antiepileptics, 5HT3-receptor antagonists, Aspirin, Coumarins, Cyproheptadine, Dabigatran, Dapoxetine, Duloxetine, Lithium, Methylphenidate, Methylthioninium, Metoclopramide, NSAIDs (should be avoided), Naratriptan, Pimozide, Rasagiline, Ritonavir, St John's Wort and Vortioxetine. Tramadol and Fentanyl will be avoided due to their serotonergic action, but all other opioids will not be grounds for exclusion.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess brain activity under Psilocybin in a cohort of people with fibromyalgia.
Read the detailed description
This mechanistic (Non-CTIMP) study will utilise a within-subjects design to examine a candidate brain biomarker of increased plasticity under Psilocybin. Up to 25mg of Psilocybin will be administered under standardised conditions on two occasions, separated by four weeks with in-dosing EEG recordings.
The primary end-point will take place 8 weeks from the first dosing session after which patients will be remotely monitored monthly for 6 months.
- Conditions
- Fibromyalgia
- Being tested
- Psilocybin, Therapeutic support
- Keywords
- Fibromyalgia, Psilocybin, Lempel-Ziv Complexity, Psychological Flexibility, 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
Also called O-phosphoryl-4-hydroxy-N,N-dimethyltryptamine
Up to 25mg of Psilocybin on 2 occasions.
Therapeutic supportBehavioural
Psychological and physical therapeutic support
| Study group | Role | What they receive |
|---|---|---|
| Fibromyalgia Cohort | *As diagnosed by an appropriate medical professional according to the American College of Rheumatology(ACR) diagnostic criteria Receives: Drug: Psilocybin; Behavioral: Therapeutic support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lempel-Ziv complexity (LZc)
Lempel-Ziv complexity (LZc) of spontaneous brain activity recorded via EEG.
Measured: 8 weeks
The Brief Experiential Avoidance Questionnaire (BEAQ)
Experiential avoidance as a part component of psychological flexibility
Measured: 8 weeks
Secondary outcomes (4)
MRI
Structural and functional magnetic resonance imaging
Measured: 8 weeks
Patient reported outcome measures
Secondary outcomes will aim to capture broad aspects of the pain experience
Measured: 6 months
Physiology: Heart rate, body temperature, accelerometry
Wearable technology will capture physiological outcomes
Measured: 8 weeks
Qualitative interviews
Semi-structured and unstructured interviews
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start15 Aug 2022
- Primary completion10 Jan 2024
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Nutt, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548075
- Sponsor's protocol ID
- 275349
- Other IDs
- EUPAS48284
- Acronym
- Psilopain
- Status last verified
- Jan 2024
- First submitted
- 16 Sep 2022
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psilocybin in Patients With Fibromyalgia: EEG-measured Brain Biomarkers of Action
- ClinicalTrials.gov ID
- NCT05548075
- Acronym / sponsor ID
- Psilopain / 275349
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Psilocybin, Lempel-Ziv Complexity, Psychological Flexibility, Chronic Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 21 Sep 2022 (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.
The purpose of this study is to assess brain activity under Psilocybin in a cohort of people with fibromyalgia.
Detailed description
This mechanistic (Non-CTIMP) study will utilise a within-subjects design to examine a candidate brain biomarker of increased plasticity under Psilocybin. Up to 25mg of Psilocybin will be administered under standardised conditions on two occasions, separated by four weeks with in-dosing EEG recordings.
The primary end-point will take place 8 weeks from the first dosing session after which patients will be remotely monitored monthly for 6 months.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia Cohort | – | Drug: Psilocybin, Behavioral: Therapeutic support*As diagnosed by an appropriate medical professional according to the American College of Rheumatology(ACR) diagnostic criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Fibromyalgia lasting for more than 3 months, as diagnosed by an appropriate medical professional using the American College of Rheumatology diagnostic criteria.
Key inclusion criteria (6 listed)
- Fibromyalgia lasting for more than 3 months, as diagnosed by an appropriate medical professional using the American College of Rheumatology diagnostic criteria.
- Over 18 years of age
- United Kingdom (UK) resident registered with a primary care medical practice
- Sufficiently competent in English with capacity to provide written informed consent
- Agreement for research team to contact primary and/or secondary care team over the course of the study
Key exclusion criteria (19 listed)
- Current or previously diagnosed psychotic disorder or bipolar disorder
- Immediate family member with a diagnosed psychotic disorder
- History of serious suicide attempts or presence of significant suicide/self-harm risk at screening
- Emotionally unstable personality, history of mania, or other psychiatric problem that the screening clinician feels may jeopardise the therapeutic alliance and/or safe exposure to psilocybin
- Currently using medication which could interact with psilocybin including anti-psychotics, mood stabilizers \& serotonergic antidepressants including selective serotonin reuptake inhibitors (SSRIs), SNRIs, and tricyclic antidepressants (TCAs)*
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 |
|---|---|---|
| PsilocybinAlso: O-phosphoryl-4-hydroxy-N,N-dimethyltryptamineUp to 25mg of Psilocybin on 2 occasions. | Drug | Fibromyalgia Cohort |
| Therapeutic supportPsychological and physical therapeutic support | Behavioural | Fibromyalgia Cohort |
Primary outcome
Lempel-Ziv complexity (LZc)
Time frame: 8 weeks
Lempel-Ziv complexity (LZc) of spontaneous brain activity recorded via EEG.
The Brief Experiential Avoidance Questionnaire (BEAQ)
Time frame: 8 weeks
Experiential avoidance as a part component of psychological flexibility
4 secondary outcomes
MRI
Time frame: 8 weeks
Patient reported outcome measures
Time frame: 6 months
Physiology: Heart rate, body temperature, accelerometry
Time frame: 8 weeks
Qualitative interviews
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
David Nutt principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by Imperial College London at 1 site in United Kingdom.
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 6 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lempel-Ziv complexity (LZc) (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2024.