Fibromyalgia
Conditions
Interventions
Patients will inhale Bedrocan©, Bedrolite© and Bediol© (Bedrocan BV, Veendam, The Netherlands) on four separate treatment days.
Sponsors
Leiden University Medical Center (LUMC)
Eligibility
Inclusion criteria
Inclusion criteria: Female fibromyalgia patients will be included if they have a pain score ≥ 5 for most of the day and meet the 2010 American College of Rheumatology diagnostic criteria.
Exclusion criteria
Exclusion criteria: (i) Unable to give written informed consent; (ii) presence of medical disease that may alter PKPD of cannabinoids such as pulmonary, renal, liver, cardiac, gastro‐intestinal, vascular disease; (iii) allergy to study medication; (iv) use of strong opioids; (v) use of benzodiazepines; (vi) history of illicit drug abuse (incl. cannabisrelated products) or alcohol abuse; (vii) (family) history of psychosis; (viii) epilepsy; (ix) raised intracranial pressure;(x) pregnancy and/or lactation; (xi) the presence of pain syndromes other than fibromyalgia; (xii) age < 18 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK data, spontaneous and experimental pain relief | — |
Secondary
| Measure | Time frame |
|---|---|
| Mental state using Bowdle and Bond & Lader questionnaires. | — |
Contacts
Public ContactM. Niesters
Leiden University Medical Center
Outcome results
None listed