Abdominal pain resulting from chronic pancreatitis (CP) 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 pharmacokinetic profile, provides the opportunity to test the analgesic potential of Δ9-THC in favourable conditions. The current study aims to investigate the analgesic efficacy of Namisol® as add-on analgesic during a long-term treatment (52 days) of abdominal pain resulting from CP.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
29
The add-on treatment consists of two phases: a step-up phase (day 1-5: 3 mg TID; day 6-10: 5 mg TID), and a stable dose phase (day 11-52: 8 mg TID). The dosage may be tapered to at least 5 mg TID, when 8 mg is not tolerated.
Identical step-up approach to the Namisol arm.
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands
Average VAS pain
The primary outcome measure is defined as the reduction in average VAS pain scores at the end of the study (day 50-52) compared to the pre-treatment level between the Namisol® and placebo group, measured by a Visual Analoge Scale (VAS) in a daily pain diary.
Time frame: Baseline versus day 52
EEG
Electroencephalogram; measuring evoked potentials to noxious electrical stimuli, evoked potentials to auditory stimuli (oddball), and FFT of spontaneous EEG.
Time frame: Baseline and day 52
QST
Quantitative Sensory Testing; measuring pressure pain thresholds, electrical thresholds, electric wind-up response, and DNIC.
Time frame: Baseline versus day 15 and day 52
Safety
* Laboratory * ECG * HF / BP * Adverse events
Time frame: Baseline until follow-up (day 59-61)
Pharmacokinetics
THC, 11-OH-THC and THC-COOH concentrations
Time frame: Predose levels at baseline, day 15 and day 52; postdose levels (30 min, 45 min, 60 min, 100 min) at day 15 and 52
Functional parameters
* Body weight * Supplementary feeding
Time frame: Baseline until day 52
Quality of life
Quality of life will be evaluated by questionnaires
Time frame: Baseline versus day 52
Pharmacodynamics
Pharmacodynamics measured by body sway and questionnaires (VASBond \& Lader and VASBowdle)
Time frame: Baseline versus day 15 and day 52
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