1. Determination of the PK of THC, CBD after inhalation of cannabis products Bedrocan©, Bedrolite© and Bediol© 2. Determination of the analgesic effects of THC, CBD and the combination of THC and CBD after inhalation of cannabis products Bedrocan©,…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
chronische pijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main end-points: PK data, spontaneous and experimental pain relief.
Secondary outcome
Secondary end-points: Blood pressure, cardiac output, temperature, mental state
(drug high, internal perception, external perception, depression, anxiety,
arousal, positive mood, alertness, contentment, calmness), psychomimetic side
effects.
Background summary
Various studies examined the effects of cannabinoids on pain relief in a
multitude of pain syndromes (including neuropathic pain, fibromyalgia, spinal
cord injury, diabetic neuropathy, general chronic pain, spasticity and
neuropathic pain in multiple sclerosis, brachial plexus avulsion, rheumatoid
arthritis, cancer pain, HIV neuropathy, post-traumatic neuropathy and Crohn*s
disease). Few studies addressed the effect of the highly purified components of
medicinal cannabis, delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD).
In the current protocol we aim to study and model the pharmacokinetics and
pharmacodynamics of inhaled medicinal cannabinoids: Bedrocan©, Bedrolite© and
Bediol© (Bedrocan, Veendam, The Netherlands) in fibromyalgia patients with
chronic pain. We will study blood concentrations, pain relief (spontaneous and
experimentally induced pain) as well as subjective effects.
Study objective
1. Determination of the PK of THC, CBD after inhalation of cannabis products
Bedrocan©, Bedrolite© and Bediol©
2. Determination of the analgesic effects of THC, CBD and the combination of
THC and CBD after inhalation of cannabis products Bedrocan©, Bedrolite© and
Bediol©
3. Determination of the subjective effects of THC, CBD and the combination of
THC and CBD after inhalation of cannabis products Bedrocan©, Bedrolite© and
Bediol©
4. Determination of the hemodynamic and temperature effects of THC, CBD and the
combination of THC and CBD after inhalation of cannabis products Bedrocan©,
Bedrolite© and Bediol©
Study design
Dubble blind, randomized, placebo-controlled, crossover design
Intervention
1. inhalation of cannabis
2. questionnaires (HADS, Bond & Lader, Bowdle, POMS)
3. Blood sampling
4. pain testing
5. Cornea photo (Cornea Confocal Microscopy)
Study burden and risks
There are five distinct activities in this study, each with their own (limited)
discomfort to the participants.
1. Inhalation of cannabis. In rare occasions cannabis can induces psychomimetic
side effects, especially in subjects that are prone to such effects. Regarding
psychotypical side effects, patients with a (family) history of psychotic
disorders and bipolar disease will not be enrolled in the study. Regarding
anxiety, some anxiety may occur but this is often self-limiting after
reassurance. Additionally, (mild) nausea has been reported. We will assess the
level of nausea and the decide whether additional treatment is required.
Anti-emetics can be given via the intravenous access line
2. Intravenous line and arterial line. Apart from some possible bruising, no
discomfort is expected from the placement of the intravenous and arterial
lines.
3. Questionnaires. No discomfort is expected from the surveys.
4. Pain Testing. The pain testing is purposefully painful. No long-term effects
are seen using the electrical and pressure pain tests.
5. Cornea Confocal Microscopy. The cornea will be anesthetized. Hence the test
is painless. No discomfort is expected from this test.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
Twenty pain patients diagnosed with fibromyalgia will be included if they have a pain score p(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.
Exclusion criteria
i) Unable to give written informed consent; (ii) medical disease such as pulmonary, renal, liver, cardiac, gastro-intestinal, vascular disease; (iii) allergy to study medication; (iv) use of strong opioids; (v) use of benzodiazepines; (vi) history of illicit drug use (incl. cannabis-related products) or alcohol abuse; (vii) (family) history of psychosis; (viii) epilepsy; (ix) raised intracranial pressure;(x) pregnancy and/or lactation; (xi) the presence of pain syndromes other than fibromyalgia.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2015-003811-39-NL |
| CCMO | NL54902.058.15 |