←Safety & Adverse Effects

Study register · detail RCT (randomized, double-blind, placebo-controlled crossover) · Safety & Adverse Effects · 2016

Single dose delta-9-tetrahydrocannabinol in chronic pancreatitis patients: analgesic efficacy, pharmacokinetics and tolerability

de Vries et al. ·British Journal of Clinical Pharmacology Impact 2.1

No benefit demonstrated GRADE Moderate 51 citations

Samplen = 24 Pat.

DurationSingle dose

ControlActive placebo

EndpointVAS

Blindingdoppelblind

DesignRCT (randomized, double-blind, placebo-controlled crossover)

Cannabinoidthc

Max. dose8.0 mg

Routeoral

Key finding

Δ9-THC did not significantly reduce chronic abdominal pain in pancreatitis compared to active placebo.

Summary

n=24 patients (chronic pancreatitis), Δ9-THC 8 mg oral vs. diazepam; feeling of anxiety and heart rate significantly increased after THC (p significant); most common adverse events: somnolence, dry mouth, dizziness, euphoric mood. THC overall well tolerated; no serious adverse events with single dose.

PopulationPatients with chronic pancreatitis and chronic abdominal pain, n=24, divided into opioid and non-opioid users

InterventionOral Δ9-THC 8 mg, single dose (double-dummy design)

ControlActive placebo: diazepam 5 mg/10 mg oral, single dose

OutcomeNo significant treatment effect on delta VAS pain scores after Δ9-THC vs. diazepam; heart rate and feeling of anxiety significantly increased under Δ9-THC

Confidence in the evidence

Moderate

The third of four GRADE levels, the effect estimate is probably reliable.

Downgraded for

Imprecision

Quality profile

Sample size ★★★★★

Blinding Double-blind

Effect size No benefit

Citations / year ★★★★★

Authors

de Vries M, Van Rijckevorsel D C M, Vissers K C P et al.

DOI 10.1111/bcp.12811↗

Design: RCT (randomized, double-blind, placebo-controlled crossover)

Abstract

<h4>Aim</h4>We aimed to assess the analgesic efficacy, pharmacokinetics, tolerability and safety of a single dose of Δ9-THC in patients with chronic abdominal pain resulting from chronic pancreatitis (CP).<h4>Methods</h4>This was a randomized, single dose, double-blinded, placebo-controlled, two way crossover study in patients suffering from abdominal pain as result of CP (n = 24), post hoc subdivided into opioid and non-opioid users. Δ9-THC (8 mg) or active placebo (5 mg/10 mg diazepam) was administered orally in a double dummy design.<h4>Results</h4>No treatment effect was shown for delta VAS pain scores after Δ9-THC compared with diazepam. Δ9-THC was well absorbed with a mean tmax of 123 min. No significant differences were found between Δ9-THC vs. diazepam for alertness, mood, calmness or balance. Feeling anxious and heart rate were significantly increased after Δ9-THC compared with diazepam. The most frequently reported adverse events (AEs) after Δ9-THC administration were somnolence, dry mouth, dizziness and euphoric mood.<h4>Conclusions</h4>A single dose of Δ9-THC was not efficacious in reducing chronic pain resulting from CP, but was well tolerated with only mild or moderate AEs. The PK results in CP patients showed delayed absorption and an increased variability compared with healthy volunteers.

The impediment to action advances action. — Marcus Aurelius