Cannabis-opioid interaction in the treatment of fibromyalgia pain – an open label proof of concept study with randomization between treatment groups: cannabis, oxycodone or cannabis/oxycodon combinatio
- Conditions
- Fibromyalgia
- Registration Number
- NL-OMON26860
- Lead Sponsor
- Investigator-Initiated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
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.
The WPI defines the number of body areas in which a patient experienced pain during the last week; the SyS score indicates the level of other core symptoms of fibromyalgia such as fatigue, non-refreshing sleep and cognitive symptoms. Additionally, tender point examinations will be performed according to the 1990 American College of Rheumatology diagnostic criteria (Wolfe F, Smythe HA, Yunus MB, et al. The American College of Rheumatology 1990 criteria for the classification of fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum 1990; 33: 160–172), however these results will not be considered for in- or exclusion. The presence of autonomic complaints such as diarrhea or obstipation, dizziness, dry mouth/eyes, etc. are no reason for exclusion in the chronic pain patient group, as these are symptoms consistent with the fibromyalgia syndrome (Niesters M, Dahan A: Fibromyalgia. In: Encyclopedia of the Neurological Sciences, 2nd edition, vol. 2. Edited by Aminoff MJ, Daroff RB. Oxford: Academic Press, 2014, pp. 288-292).
(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 (> 3 months) use of strong opioids (oxycodone, fentanyl, buprenorphine, morphine) or tramadol (> 150 mg/day); (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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>symptom will result in 1 point (max. score per day = 10) for the 42 days of treatment (= max. total score = 420).
- Secondary Outcome Measures
Name Time Method The secondary outcome is pain relief. Each day the patient will give an indication of the efficacy of pain treatment.