Het effect van psilocybine op pijn bij fibromyalgiepatiënten: een multicenter trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universiteit Maastricht

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

21 Jan 2025 → ongoing

Decision date (initial)

2025-01-21

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-516890-63-00

EudraCT number

2021-002909-10

ClinicalTrials.gov

NCT06368492

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

Primary Objective: The primary objective is to assess the effects of low psilocybin doses on pain perception in FM patients and their association with BDNF levels.

Secondary objectives 1

1. Secondary Objective(s): The secondary objective is to assess the impact of low psilocybin doses on mood, cognition, personality, autobiographical memory functioning and psychedelic experience. We will also test whether hypnotic suggestions can moderate the potential effects of psilocybin on pain perception and tolerance. Finally, we will test whether the plasma levels of inflammatory biomarkers (IL-1α, IL-1β, IL-6, IL-8, and TNF)

Conditions and MedDRA coding

Fibromyalgia

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. Age between 18 and 65 years
2. Normal weight, body mass index (weight/height2) between 18 and 30 kg/m2
3. Fulfilment of the American College of Rheumatology criteria for FM diagnosis (43)
4. A minimum NRS pain score of 5 out of 10
5. Proficient knowledge of the Dutch or English language
6. Written Informed Consent
7. Understanding the procedures and the risks associated with the study
8. No regular use of psychotropic medication such as opiates, muscle relaxants, anticonvulsants, sleep aids, benzodiazepines, MAO-A inhibitors. 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.
9. Willingness to refrain from taking psychoactive substances during the study.
10. 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
11. Willingness not to drive a traffic vehicle or to operate machines within 24 h after substance administration

Exclusion criteria 11

1. Presence of inflammatory rheumatic diseases such as ankylosing spondylitis.
2. Presence or history of psychotic, bipolar or substance use disorder as determined by the medical questionnaire, drug questionnaire and medical examination
3. Current mental health diagnosis
4. Previous experience of serious side effects to psychedelic drugs (anxiety or panic attacks)
5. Tobacco smoking (>20 per day)
6. Excessive drinking (>20 alcoholic consumptions per week)
7. Psychotic disorder in first-degree relatives
8. Pregnancy or lactation
9. Hypertension (diastolic > 90 mmHg; systolic > 140 mmHg)
10. History of cardiac dysfunctions (arrhythmia, ischemic heart disease…)
11. For women: no use of a reliable contraceptive

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. We hypothesize that psilocybin will induce significant analgesic effects at 5 mg and 10 mg compared to placebo as measured by subjective measures and the outcomes of the PPT and CPT. We also hypothesize that these potential effects will be associated with variations in BDNF levels.

Secondary endpoints 1

1. The secondary objective is to assess the impact of low psilocybin doses on mood, cognition, personality, autobiographical memory functioning and psychedelic experience. We will also test whether hypnotic suggestions can moderate the potential effects of psilocybin on pain perception and tolerance. Finally, we will test whether the plasma levels of inflammatory biomarkers (IL-1α, IL-1β, IL-6, IL-8, and TNF-α, C-reactive protein (CRP)) will decrease in response to psilocybin administration.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universiteit Maastricht

Sponsor organisation

Universiteit Maastricht

Address

P. O. Box 616

City

Maastricht

Postcode

6200 MD

Country

Netherlands

Scientific contact point

Organisation

Universiteit Maastricht

Contact name

Mauro Cavarra

Public contact point

Organisation

Universiteit Maastricht

Contact name

Mauro Cavarra

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 20 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications