Chronic fibromyalgia pain
Conditions
Interventions
Product Name: Bediol Cannabis Flos
Pharmaceutical Form: Granules in single-dose container
INN or Proposed INN: DELTA-9-TETRAHYDROCANNABINOL
CAS Number: 1972-08-3
Other descriptive name: DELTA-9-TETRAH
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Fibromyalgia patients with a pain score = 5 (on a scale from 0 = no pain to 10 = most pain imaginable) for most of the day and meet the 2010 American College of Rheumatology diagnostic criteria (Wolfe F, Clauw DJ, Fitzcharles MA, et al. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res 2010; 62: 600–10). These criteria include (i) a widespread pain index (WPI) = 7 (on a scale from 0 to 19); (ii) and a symptom severity (SyS) score = 5 (on a scale from 0 to 12) or a WPI of 3-6 and a SyS score = 9. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: (i) Unable to give written informed consent; (ii) presence of medical disease that may alter the pharmacokinetics of inhaled cannabinoids or oral oxycodone such as pulmonary or liver disease; (iii) allergy to study medication; (iv) prolonged use of strong opioids (> 3 months); (v) history of illicit drug abuse or alcohol abuse; (vi) (family) history of psychosis; (vii) pregnancy and/or lactation; (vii) the presence of pain syndromes other than fibromyalgia; (viii) age < 18 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to assess whether Bediol (containing THC and CBD) co-treatment will reduce opioid side effects in chronic pain patients. ;Secondary Objective: A secondary objective will be that Bediol is superior to oxycodone in the relief of chronic fibromyalgia pain. ;Primary end point(s): The main study outcome is the number of side effects observed during the course of treatment. To that end we will construct a composite side effects score. The score includes the following 10 symptoms dizziness (when getting up), sleepiness, insomnia, headache, nausea, vomiting, constipation, drug high, hallucinations, paranoia. The subjects will score all of these symptoms at the end of each day of treatment on paper. Each positive symptom will result in 1 point (max. score per day = 10) for the 42 days of treatment (= max. total score = 420).;Timepoint(s) of evaluation of this end point: End of trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary outcome is pain relief. Each day the patient will give an indication of the efficacy of pain treatment. There will be several questions asked (on paper): (1) How much pain did you experience on average over the last 24 h (score 0-10); (2) What was the maximum pain that you experienced over the last 24 h (score 0-10); (3) How satisfied are you with the treatment over the last 24 h (score 0-10); (4) How dissatisfied are you with your pain over the last 24 h (score 0-10); (5) How do you rate the treatment in relation to the side effects (score 0-10); Q1 and 2: score 0 = no pain, score 10 = the most severe pain imaginable; Q3-5: score 0 = not satisfied at all, score 10 = very satisfied with this treatment; At the end of the treatment period we will ask these same questions but then also for the complete treatment period. Upon follow-up we will continue asking Q1 and 2 on a weekly basis for 6 weeks. ;Timepoint(s) of evaluation of this end point: End of trial. | — |
Countries
Netherlands
Contacts
Public ContactAlbert Dahan
Leiden University Medical Center
Outcome results
None listed