The main goal of this trial is to study the efficacy of Namisol® after a single dose of Δ9-THC in the treatment of pain resulting from chronic pancreatitis. Objective measures of pain processing, e.g. encephalography (EEG) and quantitative sensory testing (QST), are included to provide insight in underlying nociceptive processing.
The most important symptom in chronic pancreatitis (CP) is abdominal pain. Pancreatic pain is often recurrent, intense and long-lasting, and is extremely difficult to treat. Medical analgesic therapy is considered as first choice in pain management of CP, resulting in regularly prescription of opioids. The adverse consequences of prolonged opioid use, including addiction, tolerance and opioid induced hyperalgesia, call for an alternative medical treatment. Cannabis has been used to treat pain for many centuries. Delta-9-tetrahydrocannabinol (Δ9-THC), the psychoactive substance of the cannabis plant, has been shown in previous studies to be a promising analgesic. The development of Namisol®, a tablet containing purified Δ9-THC showing an improved and reliable pharmacokinetic profile, provides the opportunity to test the analgesic potential of Δ9-THC in favourable conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands
Pain intensity (VAS pain)
Pain intensity (VAS pain at rest and on movement)
Time frame: Repeatedly; baseline until 6 hours after administration
EEG
Spontaneous EEG and evoked potentials to noxious electrical stimuli
Time frame: Repeatedly; baseline until 6 hours after administration
QST
Quantitative Sensory Testing, using pressure pain tolerance and electrical thresholds
Time frame: Repeatedly; baseline until 6 hours after administration
Body sway
Static body sway
Time frame: Repeatedly; baseline until 6 hours after administration
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