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 combination.;substudy: follow-up vragenlijst

Completed

Conditions: pain
10034606

Registration Number: NL-OMON52397

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

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.

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study outcome is the number of side effects observed during the course<br /><br>of treatment. To that end we will construct a composite side effects score. The<br /><br>score includes the following 10 symptoms dizziness (when getting up),<br /><br>sleepiness, insomnia, headache, nausea, vomiting, constipation, drug high,<br /><br>hallucinations, paranoia. The subjects will score all of these symptoms at the<br /><br>end of each day of treatment on paper. Each positive symptom will result in 1<br /><br>point (max. score per day = 10) for the 42 days of treatment (= max. total<br /><br>score = 420).</p><br>

Secondary Outcome Measures