The main objective is to assess whether Bediol (containing THC and CBD) co-treatment will reduce opioid side effects in chronic pain patients. A secondary objective will be that Bediol is superior to oxycodone in the relief of chronic fibromyalgia…
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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).
Secondary outcome
The secondary outcome is pain relief. Each day the patient will give an
indication of the efficacy of pain treatment.
Background summary
Rationale Currently, over 1.3 million individuals in the Netherlands (about 8%
of the population) use an opioid for treatment of their often musculoskeletal
(i.e. non-cancer) pain. Consequently, there is the imminent need for a
replacement therapy or for an opioid-sparing therapy such that opioid load in
the population is reduced significantly, and all opioid related morbidity is
reduced (eg, opioid-related addiction, depression, hyperalgesia (reduced pain
sensitivity), respiratory depression/death). One possible solution is to add a
cannabis variant to the treatment of chronic pain in order to reduce and
possibly even eliminate opioid therapy in chronic non-cancer pain. We
previously successfully showed that two inhaled cannabis variants, 100 mg
Bedrocan (22% THC or 220 mg per gram and less than 1% CBD) and 200 mg Bediol
(6.3% THC or 63 mg per gram and 8% CBD or 80 mg per gram) produced a
significant reduction of evoked pressure pain in patients with fibromyalgia
compared to placebo cannabis. Here we propose a study to determine the effect
of Bediol on top of opioid treatment on analgesia in patients with fibromyalgia
pain. We will perform study with a three-way parallel design in patients with
moderate to severe fibromyalgia pain. Patients will be randomized to receive
Bediol treatment, Bediol + oxycodone treatment or just oxycodone treatment. All
patients will be treated for 6 weeks and followed for another 6 weeks
Objective The main objective is to assess whether Bediol (containing THC and
CBD) co-treatment will reduce opioid side effects in chronic pain patients. A
secondary objective will be that Bediol is superior to oxycodone in the relief
of chronic fibromyalgia pain.
Study objective
The main objective is to assess whether Bediol (containing THC and CBD)
co-treatment will reduce opioid side effects in chronic pain patients. A
secondary objective will be that Bediol is superior to oxycodone in the relief
of chronic fibromyalgia pain.
Study design
This is an open-label randomized controlled trial. Patients with fibromyalgia
pain will be randomized 1:1:1 to receive daily oxycodone (Group 1), Bediol +
oxycodone (Group 2), or Bediol. All patients will be treated at home.
Intervention
Treatment with oxycodone (Group 1), oxycodone and Bediol (Group 2) or Bediol
(Groups 3) for 6 weeks.
Study burden and risks
At the doses applied in the current study and the close monitoring by the study
team of the patients we foresee just limited concern for major issues. Both
opioids and cannabis may have mental effects such as anxiety, drug high, and
psychomimetic effects (issues with internal and external perception). We will
closely monitor the patient and assess whether treatment should be modified in
case of side effects.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-001861-33-NL |
| CCMO | NL69810.058.19 |