Open-label Study to Assess the Safety and... — Clinical Trial Details

This single-group, open-label trial evaluates the safety and efficacy of two oral psilocybin doses administered two weeks apart alongside psychotherapy in adults meeting 2016 fibromyalgia survey criteria.

Primary assessments focus on change in chronic pain symptoms and related domains; safety is monitored via adverse events, ECG, and clinical interviews. Psychotherapy includes preparatory, dosing-day support, and post-dose integration sessions.

Participants

Ages

25 – 64

Sexes

Male & Female

BMI

Psychosis History

Excluded

Inclusion Criteria

Participants are eligible to be included in the study only if all of the following criteria apply:
Participant must be 25 to 64 years of age, inclusive, at the time of signing the informed consent form.
Participant must meet criteria for FM per the 2016 FM survey criteria.
Concurrent psychotherapy is allowed if the type and frequency of the therapy has been stable for at least 2 months prior to screening and is expected to remain stable during participation in the study.
Participant must be a non-smoker (tobacco).
Participant must be medically stable as determined by screening for medical problems via a personal interview and/or a medical questionnaire, and an ECG, within 1 month of starting active intervention.
Participant must agree to consume approximately the same amount of caffeine-containing beverage on the mornings of psilocybin session days as they usually do.
Participant must agree to refrain from using any psychoactive drugs, including alcoholic beverages and nicotine, within 24 hours before and after each psilocybin administration (exception: caffeine).
Participant must agree not to take sildenafil, tadalafil, or similar medications within 72 hours before and after each psilocybin administration.
Participant must agree to not take any PRN medications on the mornings of psilocybin sessions.
For 7 days before each psilocybin session, participant will refrain from taking any nonprescription medication, cannabis, nutritional supplement, or herbal supplement except when approved by the PI (exceptions include acetaminophen, NSAIDs, common vitamins/minerals).
Participant must have at least a high school level of education or equivalent.

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:
Within the past 1 year: cardiovascular condition such as coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g., atrial fibrillation), prolonged QTc (>450 msec), artificial heart valve, or transient ischemic attack.
Epilepsy with a history of seizures.
Insulin-dependent diabetes, or taking an oral hypoglycemic agent with a history of hypoglycaemia.
Active autoimmune disease (e.g., lupus, rheumatoid arthritis).
Current or past history of DSM-5 schizophrenia spectrum or other psychotic disorders, or bipolar I or II disorder (except substance/medication-induced or due to another medical condition).
Current or past history (within 1 year) of moderate or severe alcohol, tobacco, or other drug use disorder (excluding caffeine).
History of a medically significant suicide attempt.
Taking psychoactive prescription medication regularly (e.g., opioids, tramadol, benzodiazepines) more than twice weekly.
Currently taking an antidepressant (participants must refrain from antidepressants through completion of primary outcome assessments; re-screening allowed after appropriate washout/taper per physician guidance).
Currently taking bupropion or antidepressants other than SSRIs/SNRIs, or any regularly used centrally-acting serotonergic medication (including MAOIs) without appropriate washout.
Positive breath alcohol or urine test for cocaine, methamphetamine, or opioids above allowed thresholds.
Psychiatric condition judged incompatible with establishing rapport or safe exposure to psilocybin.
Currently enrolled in another clinical trial.

Company

Product

Legal

Open-label Study to Assess the Safety and Efficacy of Psilocybin With Psychotherapy in Adult Participants With Fibromyalgia

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Related Publications

Preliminary safety and effectiveness of psilocybin-assisted therapy in adults with fibromyalgia: An open-label, proof-of-concept clinical trial

Integration

Therapeutic Protocol

Study Arms & Interventions

Oral Psilocybin + Therapy

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details