PSILOCYBINE for Fibromyalgia

Inclusion criteria

• {"criterion_text":"- Age between 18 and 65 years\n- 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\n- Willingness not to drive a traffic vehicle or to operate machines within 24 h after substance administration\n- Normal weight, body mass index (weight/height2) between 18 and 30 kg/m2\n- Fulfilment of the American College of Rheumatology criteria for FM diagnosis (43)\n- A minimum NRS pain score of 5 out of 10\n- Proficient knowledge of the Dutch or English language\n- Written Informed Consent\n- Understanding the procedures and the risks associated with the study\n- 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.\n- Willingness to refrain from taking psychoactive substances during the study."}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Analgesic effects measured by subjective measures and the outcomes of the PPT (pressure pain threshold) and CPT (cold pressor test); association with changes in BDNF levels (plasma)."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Assessment of mood, cognition, personality, autobiographical memory functioning and psychedelic experience using subjective and clinical measures; testing moderation by hypnotic suggestions on pain perception/tolerance; measuring plasma inflammatory biomarkers IL-1α, IL-1β, IL-6, IL-8, TNF-α and CRP pre- and post-administration."}

Netherlands

Earliest CTIS Part Ii Submission Date

16-10-2024

Latest Decision Or Authorization Date

14-08-2025

Processing Time Days

302

Number Of Sites

2

Number Of Participants

35

Primary sponsor

Full Name

Universiteit Maastricht

Organisation Type

Educational Institution

Country Of Registered Address

Netherlands