Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06368492
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2023-10-31
Brief Title:
The Impact of Psilocybin on Pain in Fibromyalgia Patients
Sponsor:
Maastricht University
Organization:
Maastricht University
Study Overview
Official Title:
The Impact of Psilocybin on Pain in Fibromyalgia Patients a Multicentre Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PsiloFM
Brief 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 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
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 parametersendpoints 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
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 parametersendpoints 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NL7800806821 | OTHER | METC azMMaastricht University | None |
| 2021-002909-10 | EUDRACT_NUMBER | None | None |