Interaction between opioids and cannabinoids in the treatment of fibromyalgia pai

Phase 1

• Conditions: Chronic fibromyalgia pain; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2019-001861-33-NL
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-20
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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.

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

(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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.