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|Title||Tetrahydrocannabinol Does not Reduce Pain in Patients With Chronic Abdominal Pain in a Phase 2 Placebo-controlled Study.|
|Author(s)||de Vries M, van Rijckevorsel DC, Vissers KC, Wilder-Smith OH, van Goor H; Pain and Nociception Neuroscience Research Group.|
|Journal, Volume, Issue||Clin Gastroenterol Hepatol. 2016 Oct 5. pii: S1542-3565(16)30858-8. doi: 10.1016/j.cgh.2016.09.147. [Epub ahead of print]|
|Major outcome(s)||No effect of THC on pain in patients with abdominal pain|
BACKGROUND & AIMS: Delta-9-tetrahydrocannabinol (THC) is the most abundant cannabinoid from the plant Cannabis sativa. There is only equivocal evidence that THC has analgesic effects. We performed a phase 2 controlled trial to evaluate the analgesic efficacy, pharmacokinetics, safety, and tolerability of an oral tablet containing purified THC in patients with chronic abdominal pain. METHODS: Sixty-five patients with chronic abdominal pain for 3 months or more (numeric rating scale scores of 3 or more) after surgery or due to chronic pancreatitis were randomly assigned to groups given the THC tablet or identical matching placebos for 50-52 days. Subjects in the THC group were given the tablet first in a step-up phase (3 mg, 3 times daily for 5 days and then 5 mg, 3 times daily for 5 days) followed by a stable dose phase (8 mg, 3 times daily until day 50-52). Preceding and during the entire study period, patients were asked to continue taking their medications (including analgesics) according prescription. Patients reported any additional pain medications in a diary. Efficacy and safety assessments were conducted preceding medication intake (day 1), after 15 days, and at 50-52 days. Plasma samples were collected on study days 1, 15, and 50-52; mean plasma concentration curves of THC and 11-OH-THC were plotted. The primary endpoint was pain relief, measured by a visual analogue scale of the mean pain (VAS mean scores), based on information from patient diaries. Secondary endpoints included pain and quality of life (determined from patient questionnaires), pharmacokinetics, and safety. RESULTS: At days 50-52, VAS mean scores did not differ significantly between the THC and placebo groups (F(1, 46) =.016; P=.901). Between the start and end of the study, VAS mean scores decreased by 1.6 points (40%) in the THC group compared to 1.9 points (37%) in the placebo group. No differences were observed in secondary outcomes. Oral THC was generally well absorbed. Seven patients in the THC group stopped taking the tablets due to adverse events, compared with 2 patients in the placebo group. All (possibly) related adverse events were mild or moderate. CONCLUSIONS: In a phase 2 study, we found no difference between a THC tablet and a placebo tablet in reducing pain measures in patients with chronic abdominal pain. THC, administered 3 times daily, was safe and well tolerated during a 50-52 day treatment period. Clinicaltrials.gov no: NCT01562483 and NCT01551511.
|Participants||65 patients with chronic abdominal pain|
|Type of publication||Medical journal|
|Address of author(s)||Department of Surgery, Radboud university medical center, Nijmegen, The Netherlands. Electronic address: firstname.lastname@example.org.|